Wallflex and Agile Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected 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 an FDA Class II medical device recall involving a potential mechanical defect (catheter tip detachment) that poses a risk of harm during device use. No illnesses, injuries, or deaths have been reported. The recall addresses a risk-of-harm scenario without documented adverse events, meeting the criteria for Score 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling the Wallflex FC (Fully Covered) Esophageal Stent System and the Agile Esophageal Over the Wire (OTW) Stent System. These devices are intended for maintaining esophageal patency in patients with esophageal strictures caused by malignant tumors or concurrent esophageal fistulas.
The recall is issued due to the potential for the delivery catheter tip to detach during the stent placement or removal procedure.
Approximately 145 units have been distributed worldwide, including throughout the United States and in APAC, Canada, EMEA, and LATAM regions. The affected lot numbers are: 32752366, 32752367, 32789716, 32919840, 32927193, 32956258, 32994874, and 33056529.
Healthcare providers should verify lot numbers before use and contact Boston Scientific Corporation or the FDA for further guidance regarding affected units.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV 23X155MM- 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 esoph
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 145
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 (8)
- GTIN: 08714729854524 Lot Numbers: 32752366
- 32752367
- 32789716
- 32919840
- 32927193
- 32956258
- 32994874
- 33056529
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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