WallFlex Esophageal Stent System Recalled for Potential Catheter Tip Detachment
Boston Scientific Corporation is recalling WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems due to potential delivery catheter tip detachment during insertion 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 an FDA Class II recall for a device defect with potential for harm. The source text indicates this is a potential hazard without reported illnesses or injuries, which per the severity rubric places it in the High (3) category for risk-of-harm products 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. These devices are used to maintain esophageal luminal patency in patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors, and for concurrent esophageal fistula occlusion.
The recall is due to the potential for delivery catheter tip detachment during insertion procedures. This could compromise the safety and effectiveness of the procedure.
Approximately 77 units have been distributed worldwide, including throughout the United States and in APAC, Canada, EMEA, and LATAM regions. The affected lot numbers are 32837018, 32946075, 33014125, and 33218762.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV LL 18X103- 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 esop
- Manufacturer
- Boston Scientific Corporation
- Hazard
- catheter-tip-detachment
- device-defect
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 (4)
- GTIN: 08714729905523 Lot Numbers: 32837018
- 32946075
- 33014125
- 33218762
Distribution
Distributed nationwide across the United States.
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