FDA Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems (516 units) due to potential for delivery catheter tip detachment during stent placement procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a potential failure mode (catheter tip detachment) that could affect proper stent placement. The defect is substantiated but no manifestations of harm are reported in the recall notice. This meets the criteria for high severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the WallFlex Esophageal Stent System and Agile Esophageal Over the Wire (OTW) Stent System. The recall affects 516 units distributed worldwide including the US and countries in Asia-Pacific, Canada, Europe, Middle East, Africa, and Latin America. The reason for the recall is a potential for delivery catheter tip detachment during the stent placement procedure.
These stent systems are used to maintain esophageal patency in patients with esophageal strictures caused by malignant tumors or concurrent esophageal fistulas. A catheter tip detachment during delivery could affect proper stent placement and complicate the procedure.
Patients and healthcare providers should contact Boston Scientific for instructions regarding their specific devices and lot numbers affected by this recall.
The recalled product
- Product
- WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-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 f
- Manufacturer
- Boston Scientific Corporation
- Hazard
- catheter-detachment
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN: 08714729778080 Lot Numbers: 32809369
- 32809370
- 32820234
- 32829719
- 32837015
- 32859849
- 32888837
- 32888838
- 32914768
- 32919658
- 32919659
- 32938991 32956256
- 32977683
- 32980850
- 32986659
- 32994875
- 32998177
- 33014830
- 33101458
- 33119730
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27