Percuflex™ Biliary
Biliary Stent with Introducer Kit
6manufacturers in China registered for this device type
20catalogue numbers in this listing
56510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2026-03-19 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-11-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00533780 | 2.3 mm Stent Diameter | Withdrawn |
| M00533820 | 10 F Stent Diameter | Withdrawn |
| M00533660 | 10 F Stent Diameter | Withdrawn |
| M00533630 | 10 cm Effective Length | Withdrawn |
| M00533610 | 7 F Stent Diameter | Withdrawn |
| M00533800 | 2.3 mm Stent Diameter | Withdrawn |
| M00533650 | 15 cm Effective Length | Withdrawn |
| M00533810 | 5 cm Effective Length | Withdrawn |
| M00533690 | 12 cm Effective Length | Withdrawn |
| M00533850 | 10 F Stent Diameter | Withdrawn |
| M00533640 | 2.3 mm Stent Diameter | Withdrawn |
| M00533790 | 2.3 mm Stent Diameter | Withdrawn |
| M00533840 | 3.3 mm Stent Diameter | Withdrawn |
| M00533620 | 7 cm Effective Length | Withdrawn |
| M00533830 | 10 cm Effective Length | Withdrawn |
| M00533700 | 3.3 mm Stent Diameter | Withdrawn |
| M00533770 | 2.3 mm Stent Diameter | Withdrawn |
| M00533760 | 5 cm Effective Length | Withdrawn |
| M00533670 | 7 cm Effective Length | Withdrawn |
| M00533680 | 3.3 mm Stent Diameter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zimmon | Cook Ireland Ltd | 213 |
| Single Use Biliary Drainage Stent V | Olympus Medical Systems Corp. | 181 |
| Mustang™ | Boston Scientific Corporation | 167 |
| Geenen | Cook Ireland Ltd | 158 |
| Cotton-Leung | Cook Ireland Ltd | 144 |
| Advanix™ Pancreatic Stent | Boston Scientific Corporation | 135 |
| Single Use Biliary Stent V | Olympus Medical Systems Corp. | 106 |
| Single-use Balloon Dilatation Catheter | LEO Medical Co., Ltd. | 102 |
| Biliary Plastic Stent Set | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| Biliary Plastic Stent | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| M-Drain | Mermaid Medical A/S | 86 |
| Advanix™ Biliary | Boston Scientific Corporation | 84 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251291 | 2025-07-03 |
| K242950 | 2024-12-06 |
| K240464 | 2024-08-30 |
| K223469 | 2023-06-15 |
| K223592 | 2022-12-29 |
| K203162 | 2020-12-18 |
| K172520 | 2017-10-04 |
| K171809 | 2017-08-09 |
| K162404 | 2016-10-12 |
| K152853 | 2015-11-20 |
| K152607 | 2015-10-27 |
| K141335 | 2014-10-17 |
| K141597 | 2014-08-22 |
| K133110 | 2014-07-02 |
| K140630 | 2014-05-23 |
| K133700 | 2014-05-14 |
| K130484 | 2013-08-09 |
| K122072 | 2012-09-28 |
| K112994 | 2012-02-10 |
| K112543 | 2011-12-29 |
| K112701 | 2011-10-25 |
| K110122 | 2011-05-12 |
| K102082 | 2010-08-23 |
| K101314 | 2010-07-23 |
| K101786 | 2010-07-23 |
| K083374 | 2009-04-22 |
| K083627 | 2009-04-07 |
| K081733 | 2008-10-27 |
| K061231 | 2006-09-01 |
| K041606 | 2004-07-07 |
| K040027 | 2004-03-30 |
| K032025 | 2003-09-25 |
| K032360 | 2003-08-27 |
| K030645 | 2003-03-25 |
| K030107 | 2003-03-21 |
| K021630 | 2002-10-25 |
| K011909 | 2001-11-28 |
| K012752 | 2001-11-15 |
| K003929 | 2001-03-22 |
| K002133 | 2000-10-12 |
| K001338 | 2000-08-30 |
| K000308 | 2000-05-19 |
| K993303 | 2000-03-23 |
| K982508 | 1998-10-16 |
| K973008 | 1997-12-15 |
| K973113 | 1997-11-10 |
| K965147 | 1997-06-30 |
| K963254 | 1997-05-21 |
| K962899 | 1997-05-20 |
| K970052 | 1997-03-25 |
| K963691 | 1996-12-12 |
| K963397 | 1996-11-25 |
| K930623 | 1994-09-28 |
| K924608 | 1994-01-26 |
| K900205 | 1991-08-20 |
| K910931 | 1991-04-02 |
Recalls
39 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 |
|---|---|---|---|---|---|
| 2026-05-21 | Class II | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. | 81,543 units | |
| 2026-05-21 | Class II | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. | 81,543 units | |
| 2026-05-21 | Class II | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. | 81,543 units | |
| 2026-05-21 | Class II | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. | 81,543 units | |
| 2026-05-21 | Class II | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. | 81,543 units | |
| 2026-05-21 | Class II | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. | 81,543 units | |
| 2025-08-28 | Class II | Process control | The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa. | 156 units | |
| 2021-10-21 | Class II | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | ||
| 2021-10-21 | Class II | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | ||
| 2021-10-21 | Class II | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | ||
| 2021-10-21 | Class II | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | ||
| 2021-10-21 | Class II | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | ||
| 2021-10-21 | Class II | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | ||
| 2021-10-21 | Class II | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | ||
| 2021-10-21 | Class II | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | ||
| 2020-09-16 | Class II | Vendor change control | RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. | 15,062 devices distributed in US. 12,930 distributed OUS | |
| 2020-08-07 | Class II | Packaging process control | Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device | 40 units | 2020-12-23 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 139 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 66 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 271 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 940 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 109 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 35 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 66 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 542 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 97 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 54 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 222 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 179 units | 2023-12-20 |
| 2019-10-21 | Class II | Incorrect or no expiration date | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | 651 units | 2023-12-20 |
| 2018-12-26 | Class II | Other | The sterile barrier may contain packaging seal defects. | 75 units | 2020-04-17 |
| 2018-12-26 | Class II | Other | The sterile barrier may contain packaging seal defects. | 18 units | 2020-04-17 |
| 2017-06-01 | Class II | Employee error | Label on the affected devices incorrectly identifies the injection location as “above” the balloon when it should be below the balloon and “below” the balloon when it should be above the balloon | 32 units | 2018-06-26 |
| 2017-06-01 | Class II | Employee error | Label on the affected devices incorrectly identifies the injection location as “above” the balloon when it should be below the balloon and “below” the balloon when it should be above the balloon | 39 units | 2018-06-26 |
| 2015-04-27 | Class II | Employee error | One lot of the Extractor” Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label. | 39 units | 2016-01-27 |
| 2015-02-25 | Class II | Device Design | Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the r | 289 | 2017-06-30 |
| 2015-02-25 | Class II | Nonconforming Material/Component | Boston Scientific is initiating this Medical Device Field Correction of the Expel” APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after an Expel” APD catheter was implanted in | 918 | 2016-08-12 |
| 2013-12-18 | Class II | Process control | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size | 39 units | 2014-08-19 |
| 2013-12-18 | Class II | Process control | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size | 38 units | 2014-08-19 |
| 2010-02-18 | Not classified | Packaging | Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determined that, the sterile barrier in the cathe | 99 | 2011-12-10 |
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.