WallFlex™ Esophageal
12 catalogue numbers from M00516700, listed by Boston Scientific Corporation, United States, under Prosthesis, Esophageal. 1 manufacturer in China is registered for this product code.
1manufacturer
12catalogue numbers in this listing
15510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | ESW |
| Device type | Prosthesis, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3610 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2024-06-18 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00516700 | 103 mm Stent Length | In distribution |
| M00516910 | 18 mm Stent Diameter | In distribution |
| M00516920 | 18 mm Stent Diameter | In distribution |
| M00516720 | 18 mm Stent Diameter | In distribution |
| M00516730 | 105 mm Stent Length | In distribution |
| M00516950 | 155 mm Stent Length | In distribution |
| M00516750 | 155 mm Stent Length | In distribution |
| M00516930 | 23 mm Stent Diameter | In distribution |
| M00516740 | 125 mm Stent Length | In distribution |
| M00516940 | 23 mm Stent Diameter | In distribution |
| M00516710 | 123 mm Stent Length | In distribution |
| M00516900 | 103 mm Stent Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hilzo Esophageal stents | BCM Co., Ltd. | 464 |
| Esophageal TTS Stent | Taewoongmedical.co., Ltd. | 144 |
| Hanarostent® Esophagus (CCC) | M.I.Tech Co Ltd | 44 |
| Hanarostent® Esophagus TTS(NCN) | M.I.Tech Co Ltd | 40 |
| Hanarostent® Esophagus TTS(CCC) | M.I.Tech Co Ltd | 40 |
| Niti-S Esophageal Stent | Taewoongmedical.co., Ltd. | 40 |
| Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 36 |
| Hanarostent® Esophagus Asymmetric (CCC) | M.I.Tech Co Ltd | 32 |
| Alimaxx-ES™ | Merit Medical Systems, Inc. | 27 |
| Hanarostent® Esophagus (NCN) | M.I.Tech Co Ltd | 24 |
| EndoMAXX® | Merit Medical Systems, Inc. | 24 |
| Agile™ Esophageal | Boston Scientific Corporation | 24 |
Showing 12 of 20. All products under Prosthesis, Esophageal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261978 | 2026-07-10 |
| K233939 | 2024-04-29 |
| K233837 | 2024-04-04 |
| K211960 | 2021-11-22 |
| K180144 | 2018-09-21 |
| K130004 | 2013-12-06 |
| K120983 | 2012-05-02 |
| K091816 | 2009-07-01 |
| K091510 | 2009-06-26 |
| K080332 | 2008-09-05 |
| K073266 | 2008-02-27 |
| K032930 | 2003-10-23 |
| K012883 | 2001-10-12 |
| K955347 | 1996-02-16 |
| K940838 | 1994-08-18 |
Recalls Naming This Product
12 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 231 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 124 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 79 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 364 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 507 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 516 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 297 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 308 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 39 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 133 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 305 units |
| Boston Scientific Corporation | UDI-DI | 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 199 units |
Recalls
19 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 |
|---|---|---|---|---|---|
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 115 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 79 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 18 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 6 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 10 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 40 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 6 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 66 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 146 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 15 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 2 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 176 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 145 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 77 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 18 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 77 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 7 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 19 units | |
| 2024-08-01 | Class II | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | 17 units | |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 8 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 10 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 10 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 2 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 0 | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 8 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 3 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment | 9 units | 2011-10-14 |
| 2010-07-15 | Not classified | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | 9 units | 2011-10-14 |
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.