FDA Device recall Z-3285-2024
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining e…
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining e… by Boston Scientific, citing wallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3285-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-01 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516940
Reason
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Identifiers
| code_info | GTIN: 08714729765288 Lot Numbers: 32759900, 32759903, 32789717 32789718, 32829629, 32847692 32848481, 32898067, 329193…GTIN: 08714729765288 Lot Numbers: 32759900, 32759903, 32789717 32789718, 32829629, 32847692 32848481, 32898067, 32919347 32927195, 32949480, 32956257 32957302, 32965072, 32985475 32987961, 33047928, 33145976 33145978, 33208046, 33208048 33242626, 33275535 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3285-2024%22
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