Boston Scientific Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
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 classified as FDA Class II and involves a potential mechanical failure (delivery catheter tip detachment) in a device used for patient care. No illnesses or injuries have been reported. As a risk-of-harm product where injury has not yet been documented, this meets the criterion for High severity.
Plain-English summary
Boston Scientific Corporation is recalling the WallFlex Esophageal Stent System (Partially Covered and Fully Covered versions) and the Agile Esophageal Over-the-Wire Stent System. These devices are used to maintain esophageal patency in patients with esophageal strictures caused by malignant tumors and esophageal fistulas.
The recall is due to the potential for delivery catheter tip detachment during the stent placement procedure.
The recall affects 231 units distributed worldwide, including throughout the United States and in APAC, Canada, EMEA, and LATAM regions. Affected lot numbers are specified in the FDA recall documentation.
Patients and healthcare providers should contact Boston Scientific immediately. Do not use affected units. Consult your healthcare provider if you have concerns about stents already placed using affected lots.
The recalled product
- Product
- WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent e
- Manufacturer
- Boston Scientific Corporation
- Hazard
- delivery-catheter-detachment
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 (15)
- GTIN: 08714729778035 Lot Numbers: 32779260
- 32790021
- 32817917
- 32860922
- 32906415
- 32966005
- 32967262
- 33026701
- 33026703
- 33077154
- 33077157
- 33085584 33147800
- 33156072
- 33218764
- 33256093
Distribution
Distributed nationwide across the United States.
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