Agile™ Esophageal
Partially Covered OTW Stent System
1manufacturer
24catalogue 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 | 2020-05-29 |
| Record revised | 2022-11-28 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Stent diameter 14 to 23 mm; stent length 59 to 150 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00517440 | Stent Diameter 18 mm | In distribution |
| M00517780 | Stent Diameter 23 mm | In distribution |
| M00517220 | Stent Length 119 mm | In distribution |
| M00517210 | Stent Length 102 mm | In distribution |
| M00517250 | Stent Length 97 mm | In distribution |
| M00517470 | Stent Diameter 18 mm | In distribution |
| M00517450 | Stent Diameter 18 mm | In distribution |
| M00517260 | Stent Length 119 mm | In distribution |
| M00517240 | Stent Length 59 mm | In distribution |
| M00517400 | Stent Length 62 mm | In distribution |
| M00517200 | Stent Diameter 14 mm | In distribution |
| M00517460 | Stent Length 119 mm | In distribution |
| M00517270 | Stent Diameter 18 mm | In distribution |
| M00517430 | Stent Diameter 14 mm | In distribution |
| M00517770 | Stent Diameter 23 mm | In distribution |
| M00517740 | Stent Length 150 mm | In distribution |
| M00517750 | Stent Length 62 mm | In distribution |
| M00517410 | Stent Diameter 14 mm | In distribution |
| M00517720 | Stent Diameter 23 mm | In distribution |
| M00517420 | Stent Length 119 mm | In distribution |
| M00517230 | Stent Diameter 14 mm | In distribution |
| M00517710 | Stent Length 62 mm | In distribution |
| M00517760 | Stent Diameter 23 mm | In distribution |
| M00517730 | Stent Diameter 23 mm | 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 |
| Ultraflex™ Esophageal NG | Boston Scientific Corporation | 19 |
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
6 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. | 6 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. | 15 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. | 17 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. | 18 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. | 18 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. | 19 units |
Recalls
25 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. | 507 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. | 516 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. | 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. | 199 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. | 305 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. | 124 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. | 133 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. | 364 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. | 231 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. | 297 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. | 39 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. | 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. | 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. | 308 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.