Guidezilla™ II
Guide Extension Catheter
14manufacturers in China registered for this device type
4catalogue numbers in this listing
31510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-04-03 |
| Record revised | 2021-12-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H7493933515080 | 8 F Diameter | In distribution |
| H7493933515070 | 1.98 mm Diameter | In distribution |
| H74939335150610 | 1.78 mm Diameter | In distribution |
| H7493933515060 | 6 F Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Sherpa NX Balanced™ | Medtronic, Inc. | 1,523 |
| Arrow | Teleflex Medical LLC | 1,249 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| Zuma® | Medtronic, Inc. | 569 |
| Convey | Pendracare International B.V. | 532 |
| Taiga | Medtronic, Inc. | 307 |
| RunWay™ | Boston Scientific Corporation | 300 |
| ConcierGE Guiding Excellence™ | Merit Medical Systems, Inc. | 295 |
Showing 12 of 500. All products under Catheter, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240018 | 2024-02-01 |
| K223633 | 2023-08-08 |
| K231176 | 2023-05-25 |
| K212228 | 2021-08-13 |
| K190401 | 2019-03-15 |
| K180864 | 2018-07-20 |
| K171452 | 2017-08-21 |
| K171913 | 2017-07-25 |
| K171612 | 2017-06-30 |
| K163314 | 2017-03-23 |
| K152401 | 2015-12-04 |
| K132914 | 2014-04-03 |
| K123765 | 2013-03-19 |
| K122394 | 2012-08-30 |
| K112303 | 2011-11-09 |
| K111252 | 2011-06-02 |
| K062202 | 2006-10-20 |
| K062594 | 2006-09-20 |
| K060572 | 2006-03-15 |
| K053116 | 2005-12-16 |
| K053118 | 2005-12-16 |
| K050599 | 2005-06-03 |
| K050389 | 2005-05-25 |
| K042568 | 2004-10-15 |
| K033441 | 2003-11-21 |
| K021721 | 2002-06-20 |
| K020028 | 2002-01-22 |
| K011889 | 2001-12-21 |
| K010874 | 2001-06-21 |
| K963663 | 1997-01-13 |
| K930476 | 1994-02-10 |
Recalls
11 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2025-07-29 | Class I | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requ | 340185 units in total | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 3738 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 4990 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 1170 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 2184 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 2245 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 3783 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 116 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 1004 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 4426 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 326 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 17436 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 1728 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 828 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 8475 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 3777 units | |
| 2023-07-27 | Class II | Employee error | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve sh | 1086 units | |
| 2022-08-09 | Class II | Process control | The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter. | 184 devices (UPDATED) | |
| 2021-03-05 | Class II | Labeling False and Misleading | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. | 63 devices | 2023-01-05 |
| 2021-03-05 | Class II | Labeling False and Misleading | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. | 52 devices | 2023-01-05 |
| 2020-12-15 | Class II | Process control | Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure. | 5 units | 2023-08-14 |
| 2019-10-24 | Class II | Process control | Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process. | 14,145 devices total | 2023-03-20 |
| 2017-12-11 | Class II | Process change control | Potential polymer material degradation. | 31,005 | 2019-11-04 |
| 2015-11-25 | Class II | Process control | Potential for separation of the proximal handle from the shaft. | 900 units | 2016-04-08 |
| 2014-03-03 | Class II | Packaging | The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic | 7 | 2014-06-09 |
| 2012-06-26 | Class II | Process control | BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a | 95 (57 USA, 38 OUS) | 2012-09-06 |
| 2009-12-18 | Not classified | Other | Complaint about product quality: degradation of polymer portion of the distal section of the catheter. | 94,296 units | 2011-12-19 |
| 2009-10-06 | Not classified | Environmental control | Product degradation– a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications. | 94,296 units | 2011-12-19 |
| 2009-09-29 | Not classified | Other | Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached | 9800 total (2373 US and 7427 OUS) | 2011-12-17 |
| 2009-09-29 | Not classified | Other | Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached | 9800 total (2373 US and 7427 OUS) | 2011-12-17 |
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.