Boston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment
Boston Scientific is recalling Wallflex and Agile Esophageal Stent Systems due to potential for delivery catheter tip detachment. The recall involves 124 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: FDA Class II recall for a medical device with potential delivery system failure and no reported injuries. Qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling Wallflex Esophageal Stent Systems and Agile Esophageal Over-the-Wire (OTW) Stent Systems due to potential for delivery catheter tip detachment during use.
The recalled devices are designed to maintain esophageal luminal patency in patients with esophageal strictures caused by malignant tumors or concurrent esophageal fistulas. A total of 124 units have been identified in this recall, distributed worldwide including the United States, Asia-Pacific, Canada, Europe, Middle East, Africa, and Latin America.
Consumers and healthcare providers with affected units should contact Boston Scientific for specific guidance. No illnesses or injuries related to this defect have been reported at this time.
The recalled product
- Product
- WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- 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
- Manufacturer
- Boston Scientific Corporation
- Hazard
- catheter-tip-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 (10)
- GTIN: 08714729778042 Lot Numbers: 32779261
- 32820237
- 32906416
- 33030432
- 33077155
- 33077156
- 33094173
- 33137309
- 33137313
- 33195043
Distribution
Distributed nationwide across the United States.
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