Performa®
1,101 catalogue numbers from 00884450182567, listed by Merit Medical Systems, Inc., United States, under Catheter, Intravascular, Diagnostic. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
1,101catalogue numbers in this listing
8510(k) clearances naming this product code
33recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2023-09-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5, pack of 10, pack of 3 |
| Sizes | Catheter gauge 5 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450182567 | Length-100 cm | In distribution |
| 00884450002483 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| 00884450004265 | Label Long Description-JUDKINS RIGHT 3.5 cm | In distribution |
| 00884450006047 | French Size (F)-4F | In distribution |
| 00884450025338 | Label Peelable Line 1-6F, STR PIG, PRC, JL 4.0, Performa® | In distribution |
| 00884450040485 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450119198 | Label Long Description-ULTIMATE 2 | In distribution |
| B | French Size (F)-4F | In distribution |
| 00884450000557 | Length-100 cm | In distribution |
| 00884450011249 | Length-80 cm | In distribution |
| 00884450010242 | Length-100 cm | In distribution |
| 00884450074923 | Length-100 cm | In distribution |
| 00884450258903 | French Size (F)-6F | In distribution |
| 00884450003558 | French Size (F)-4F | In distribution |
| 00884450249567 | French Size-6F (2.0 mm) | In distribution |
| 00884450283134 | Internal Diameter-0.052″ (1.32 mm) | In distribution |
| 00884450028940 | French Size (F)-5F | In distribution |
| 00884450123577 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450001370 | French Size (F)-5F | In distribution |
| 00884450074961 | Internal Diameter-0.042″ (1.07 mm) | In distribution |
| 00884450004623 | Length-125 cm | In distribution |
| 00884450230046 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| 00884450001028 | Label Long Description-AMPLATZ RIGHT 2 | In distribution |
| D | Label Long Description-MODIFIED HOOK | In distribution |
| 00884450383414 | French Size (F)-5F | In distribution |
| 00884450064542 | Label Short Description-JL 0.5 | In distribution |
| 00884450161111 | Length-110 cm | In distribution |
| 00884450269879 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450363119 | Length-100 cm | In distribution |
| 00884450011010 | Length-70 cm | In distribution |
| 00884450004388 | Label Long Description-MULTIPURPOSE B2 | In distribution |
| 00884450294888 | Label Peelable Line 1-5F, MIV RAD PIG, JR 4.0, JL 3.5, Performa® | In distribution |
| 00884450006085 | Label Long Description-HOOK 1.0 cm | In distribution |
| 00884450087688 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450003190 | Length-100 cm | In distribution |
| 00884450253137 | Length-110 cm | In distribution |
| 00884450040782 | Length-100 cm | In distribution |
| 00884450265338 | Label Short Description-MP | In distribution |
| A | Catheter Gauge 5 Fr | In distribution |
| 00884450005804 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450099483 | French Size (F)-4F | In distribution |
| 00884450006030 | French Size (F)-4F | In distribution |
| 00884450245170 | Label Peelable Line 2-100 cm, 0.038″, 1 SH, 1200 psi | In distribution |
| D | Label Long Description-MODIFIED HOOK | In distribution |
| 00884450269930 | French Size (F)-5F | In distribution |
| 00884450000915 | Length-100 cm | In distribution |
| 00884450294536 | Label Short Description-ULTIMATE 3 | In distribution |
| B | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| 00884450003534 | Label Long Description-JUDKINS RIGHT 1.5 cm BUMPER TIP | In distribution |
| 00884450294529 | French Size-5F (1.7 mm) | In distribution |
| 00884450087275 | French Size (F)-6F | In distribution |
| B | Length-100 cm | In distribution |
| 00884450362181 | Label Long Description-ULTIMATE 1 | In distribution |
| 00884450003305 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450147771 | French Size (F)-5F | In distribution |
| 00884450306604 | Internal Diameter-0.054″ (1.37 mm) | In distribution |
| 00884450025123 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450064603 | Label Short Description-LT AL 1.6 cm | In distribution |
| 00884450069899 | Label Peelable Line 1-5F, STR PIG, JR 4.0, JL 4.0, Performa® | In distribution |
| 00884450010273 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450003510 | Label Long Description-JUDKINS LEFT 2.0 cm BUMPER TIP | In distribution |
| 00884450269855 | Length-125 cm | In distribution |
| 00884450042519 | French Size (F)-4F | In distribution |
| 00884450269848 | Length-125 cm | In distribution |
| 00884450044780 | French Size (F)-4F | In distribution |
| A | French Size-5F (1.7 mm) | In distribution |
| 00884450003480 | Length-100 cm | In distribution |
| 00884450307007 | In distribution | |
| 00884450001301 | Label Long Description-JUDKINS LEFT 5.0 cm | In distribution |
| 00884450005729 | Length-100 cm | In distribution |
| 00884450004678 | Label Peelable Line 1-6F, PIG 155, JR 4.0, JL 4.0, Performa® | In distribution |
| 00884450269794 | Length-125 cm | In distribution |
| 00884450258224 | French Size (F)-5F | In distribution |
| B | Length-65 cm | In distribution |
| 00884450004852 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450025345 | Label Peelable Line 2-110/100/100 cm, 0.038″, 5 SH, 1200 psi | In distribution |
| 00884450006276 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| 00884450168097 | French Size (F)-5F | In distribution |
| 00884450082270 | Length-80 cm | In distribution |
| 00884450040621 | Internal Diameter-0.046″ (1.17 mm) | In distribution |
| 00884450002568 | Label Long Description-UHF STRAIGHT FLUSH | In distribution |
| 00884450079027 | Length-80 cm | In distribution |
| 00884450002681 | Label Long Description-BERENSTEIN 1 | In distribution |
| 00884450006245 | Length-65 cm | In distribution |
| B | Length-65 cm | In distribution |
| 00884450001257 | Label Long Description-JUDKINS RIGHT 4.0 cm | In distribution |
| 00884450043950 | French Size (F)-6F | In distribution |
| 00884450005071 | Label Long Description-BENTSON 3 | In distribution |
| 00884450004067 | Length-125 cm | In distribution |
| B | Length-100 cm | In distribution |
| 00884450159682 | Length-100 cm | In distribution |
| 00884450362105 | Label Long Description-ULTIMATE 4-T45 | In distribution |
| 00884450122914 | Label Short Description-IM | In distribution |
| 00884450766552 | Label Long Description-PEDIATRIC PIGTAIL | In distribution |
| 00884450029640 | Label Long Description-MODIFIED HOOK 2 | In distribution |
| 00884450066652 | Internal Diameter-0.046″ (1.17 mm) | In distribution |
| 00884450000991 | French Size (F)-5F | In distribution |
| 00884450023273 | Length-100 cm | In distribution |
| 00884450004340 | Length-100 cm | In distribution |
| 00884450002551 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| 00884450001431 | Label Long Description-UHF PIGTAIL | In distribution |
| A | Length-125 cm | In distribution |
| 00884450085226 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| D | Internal Diameter-0.046″ (1.17 mm) | In distribution |
| 00884450004654 | Label Peelable Line 2-110/100/100 cm, 0.038″, 5 SH, 1200 psi | In distribution |
| 00884450025154 | French Size (F)-5F | In distribution |
| 00884450004142 | French Size (F)-4F | In distribution |
| 00884450083970 | French Size-4F (1.3 mm) | In distribution |
| 00884450394465 | French Size (F)-5F | In distribution |
| 00884450065532 | French Size-5F (1.7 mm) | In distribution |
| 00884450073551 | French Size (F)-5F | In distribution |
| 00884450020500 | French Size (F)-5F | In distribution |
| 00884450088173 | Label Peelable Line 1-6F, JR 4.0, JL 4.0, Performa® | In distribution |
| 00884450023396 | French Size (F)-4F | In distribution |
| 00884450207161 | Length-85 cm | In distribution |
| 00884450002131 | French Size (F)-4F | In distribution |
| 00884450269961 | Length-125 cm | In distribution |
| 00884450283332 | Length-125 cm | In distribution |
| 00884450002827 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450356678 | Label Long Description-UHF PIGTAIL | In distribution |
| 00884450072349 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450020548 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| 00884450044629 | Length-100 cm | In distribution |
| B | French Size (F)-5F | In distribution |
| 00884450299982 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450010440 | French Size (F)-4F | In distribution |
| 00884450253151 | Internal Diameter-0.046″ (1.17 mm) | In distribution |
| 00884450004166 | French Size (F)-4F | In distribution |
| D | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450000496 | Label Long Description-BENTSON 1 | In distribution |
| 00884450270998 | Label Peelable Line 2-5F: JR 4.0, JL 3.5, Performa® | In distribution |
| 00884450064481 | French Size-4F (1.3 mm) | In distribution |
| 00884450408582 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450270011 | Label Long Description-ULTIMATE 4-T40 | In distribution |
| 00884450055465 | In distribution | |
| 00884450020470 | French Size (F)-5F | In distribution |
| 00884450004210 | French Size (F)-4F | In distribution |
| 00884450299975 | Length-65 cm | In distribution |
| 00884450003282 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450002582 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| B | Label Long Description-MODIFIED HOOK | In distribution |
| 00884450000144 | Length-65 cm | In distribution |
| 00884450072844 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450006474 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450040751 | Label Short Description-HAVI V | In distribution |
| 00884450010280 | Label Long Description-AMPLATZ LEFT 1 | In distribution |
| 00884450270981 | Label Peelable Line 2-6F: JR 4.0, JL 3.5, Performa® | In distribution |
| 00884450069790 | Length-80 cm | In distribution |
| 00884450122372 | Label Long Description-STANDARD PEDIATRIC PIGTAIL | In distribution |
| 00884450269916 | Length-125 cm | In distribution |
| 00884450079089 | French Size (F)-4F | In distribution |
| 00884450083949 | Length-80 cm | In distribution |
| 00884450004449 | French Size (F)-5F | In distribution |
| 00884450075036 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450003589 | Label Long Description-JUDKINS LEFT 2.5 cm BUMPER TIP | In distribution |
| 00884450003251 | Length-100 cm | In distribution |
| 00884450077733 | Label Long Description-JUDKINS RIGHT 4.0 cm BUMPER TIP | In distribution |
| 00884450044483 | Label Short Description-LT AL 1.3 cm | In distribution |
| 00884450000182 | Label Long Description-COBRA 3 | In distribution |
| 00884450003114 | Label Long Description-JUDKINS LEFT 5.0 cm | In distribution |
| 00884450027592 | Length-65 cm | In distribution |
| 00884450005880 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450006221 | Label Long Description-MOD SHEPHERD HOOK 1.0 cm BT | In distribution |
| 00884450258835 | Length-125 cm | In distribution |
| 00884450004951 | Label Long Description-UHF CARDIAC PIGTAIL 155 DEGREE | In distribution |
| 00884450001400 | Label Long Description-MODIFIED HOOK | In distribution |
| 00884450255254 | Label Short Description-ULTIMATE 3 | In distribution |
| 00884450002629 | Label Long Description-COBRA 3 | In distribution |
| 00884450103975 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| B | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| 00884450000229 | Label Long Description-COBRA 1 BUMPER TIP | In distribution |
| 00884450005187 | French Size (F)-6F | In distribution |
| B | Length-100 cm | In distribution |
| 00884450207178 | French Size (F)-4F | In distribution |
| 00884450082294 | Length-80 cm | In distribution |
| 00884450087329 | French Size (F)-6F | In distribution |
| 00884450151495 | French Size (F)-5F | In distribution |
| 00884450137826 | Label Peelable Line 2-100 cm, 0.038″, 1 SH, 1050 psi | In distribution |
| 00884450006450 | French Size (F)-4F | In distribution |
| 00884450253977 | Label Peelable Line 2-5F: ULTIMATE 2 w/BT, Performa® | In distribution |
| 00884450002148 | Length-100 cm | In distribution |
| 00884450004562 | Label Peelable Line 1-5F, STR PIG, JR 4.0, JL 4.0, Performa® | In distribution |
| 00884450123065 | French Size (F)-4F | In distribution |
| 00884450227992 | French Size (F)-4F | In distribution |
| 00884450009925 | Label Long Description-MODIFIED HOOK | In distribution |
| 00884450010006 | Label Long Description-MULTIPURPOSE A2 BUMPER TIP | In distribution |
| 00884450000533 | French Size (F)-4F | In distribution |
| 00884450044841 | Length-110 cm | In distribution |
| 00884450165164 | Length-110 cm | In distribution |
| D | Label Long Description-MIV RAD PIG ST | In distribution |
| 00884450002209 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450002865 | Label Long Description-HEADHUNTER 6 | In distribution |
| 00884450151488 | French Size (F)-5F | In distribution |
| 00884450269022 | French Size (F)-4F | In distribution |
| 00884450062111 | Length-65 cm | In distribution |
| 00884450002520 | French Size (F)-5F | In distribution |
| 00884450005798 | French Size (F)-5F | In distribution |
| 00884450005767 | French Size (F)-4F | In distribution |
| 00884450002803 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450004593 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450005484 | French Size (F)-6F | In distribution |
| 00884450161838 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450099186 | Label Peelable Line 2-110/100/100 cm, 0.038″, 5 SH, 1200 psi | In distribution |
| 00884450320723 | French Size (F)-5F | In distribution |
| 00884450286067 | Length-65 cm | In distribution |
| 00884450040652 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| 00884450067697 | Label Short Description-AL 0.5 | In distribution |
| 00884450000960 | French Size (F)-5F | In distribution |
| D | Length-90 cm | In distribution |
| 00884450235850 | Label Peelable Line 2-100 cm, 0.038″, 1050 psi | In distribution |
| B | French Size (F)-4F | In distribution |
| 00884450006054 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450010266 | French Size (F)-6F | In distribution |
| 00884450002575 | Label Long Description-UHF STRAIGHT FLUSH | In distribution |
| 00884450258927 | Label Long Description-ULTIMATE 3 | In distribution |
| 00884450010327 | Label Long Description-UHF CARDIAC PIGTAIL 155 DEGREE | In distribution |
| 00884450006061 | Length-65 cm | In distribution |
| 00884450022504 | French Size (F)-5F | In distribution |
| 00884450006252 | French Size (F)-4F | In distribution |
| 00884450294574 | French Size-5F (1.7 mm) | In distribution |
| 00884450269978 | Label Long Description-UHF CARDIAC PIGTAIL | In distribution |
| 00884450168110 | French Size (F)-5F | In distribution |
| 00884450044452 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450000984 | Label Long Description-INTERNAL MAMMARY | In distribution |
| 00884450009888 | Length-65 cm | In distribution |
| 00884450076132 | Length-100 cm | In distribution |
| 00884450245422 | Label Peelable Line 1-6F, JR 4.0, JL 3.5, Performa® | In distribution |
| 00884450010945 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450120323 | Length-80 cm | In distribution |
| D | Label Long Description-MODIFIED HOOK 2 | In distribution |
| 00884450088432 | French Size (F)-4F | In distribution |
| 00884450205617 | Label Peelable Line 1-6F, JR 3.5, JL 3.5, Performa® | In distribution |
| 00884450072325 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| B | Length-65 cm | In distribution |
| D | Internal Diameter-0.041″ (1.04 mm) | In distribution |
| 00884450021125 | French Size (F)-4F | In distribution |
| B | Label Long Description-UHF STRAIGHT FLUSH | In distribution |
| 00884450044407 | Length-40 cm | In distribution |
| 00884450362839 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450004456 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450258859 | Label Long Description-ULTIMATE 2 | In distribution |
| B | French Size (F)-5F | In distribution |
| 00884450004289 | French Size (F)-5F | In distribution |
| 00884450258910 | Label Long Description-ULTIMATE 2 | In distribution |
| 00884450027622 | Recommended Guide Wire-0.035″ (0.89 mm) | In distribution |
| A | Label Short Description-Spiral Angled Pig | In distribution |
| 00884450080405 | Recommended Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450240380 | Internal Diameter-0.046″ (1.17 mm) | In distribution |
| 00884450080672 | Label Peelable Line 2-110/100/100 cm, 0.038″, 5 SH, 1200 psi | In distribution |
| 00884450522721 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
| Expo™ | Boston Scientific Corporation | 180 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233268 | 2024-05-22 |
| K191608 | 2019-07-16 |
| K110643 | 2011-07-01 |
| K093004 | 2010-02-12 |
| K053171 | 2006-01-19 |
| K000659 | 2000-03-29 |
| K914208 | 1991-12-18 |
| K913682 | 1991-11-15 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-09-13 | Class II | Process control | 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. | 200 | 2014-01-03 |
| 2013-05-02 | Class II | Process control | Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape. | 1,465 | 2013-07-22 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 92 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 265 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 3,636 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 1,057 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 124 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 679 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 57 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 1033 units | 2012-03-23 |
| 2010-05-05 | Not classified | Process control | Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands. | 96 units | 2010-06-01 |
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 1 connection tube | 2009-12-15 |
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 1 connection tube | 2009-12-15 |
| 2008-09-12 | Not classified | Process control | Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748. | 399 kits | 2009-01-13 |
| 2008-04-15 | Not classified | Process control | Convenience kits may be non-sterile due to inadequate package sealing. | 10 kits | 2008-09-03 |
| 2008-04-15 | Not classified | Process control | Convenience kits may be non-sterile due to inadequate package sealing. | 10 kits | 2008-09-03 |
| 2008-04-15 | Not classified | Process control | Convenience kits may be non-sterile due to inadequate package sealing. | 119 kits | 2008-09-03 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 99 units | 2005-10-28 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 84 units | 2005-10-28 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 243 units | 2005-10-28 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 372 units | 2005-10-28 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 119 units | 2005-10-28 |
| 2004-10-15 | Not classified | Other | Merit Custom Convenience Kits contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use. | 10202 kits | 2004-12-15 |
| 2004-09-14 | Not classified | Other | Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch. | 143 kits | 2005-03-31 |
| 2003-11-05 | Not classified | Other | Angiographic catheter tips may separate during use. | 32 units | 2003-12-01 |
| 2003-11-05 | Not classified | Other | Angiographic catheter tips may separate during use. | 410 units | 2003-12-01 |
| 2003-10-01 | Not classified | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated t | 6155 units | 2004-02-02 |
| 2003-10-01 | Not classified | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated t | 30 units | 2004-02-02 |
| 2003-10-01 | Not classified | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated t | 1927 units | 2004-02-02 |
| 2003-05-16 | Not classified | Other | Cracks in the syringe barrels could allow for air aspiration into the syringe barrel. | 20 kits | 2003-07-21 |
| 2003-02-13 | Not classified | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. | 100 kits. | 2003-03-07 |
| 2003-02-13 | Not classified | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. | 250 kits | 2003-03-07 |
| 2003-02-13 | Not classified | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. | 82 kits. | 2003-03-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.