WallFlex Esophageal Stent System Recalled Due to Catheter Tip Detachment Risk
Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 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 an FDA Class II recall involving a medical device for serious esophageal conditions. However, the source describes the hazard as a 'potential for' delivery catheter tip detachment with no reported illnesses, injuries, or deaths. Per the severity rubric, recalls with theoretical hazards and no reported harm are classified as High (score 3).
Plain-English summary
Boston Scientific Corporation is recalling the WallFlex Esophageal Stent System (Partially Covered and Fully Covered variants) and the Agile Esophageal Over-the-Wire (OTW) Stent System. These esophageal stents maintain patency in patients with strictures caused by malignant tumors or esophageal fistulas.
The recall is due to a potential risk of delivery catheter tip detachment during stent placement. This could affect the delivery system's integrity and the ability to properly place the stent.
The recall impacts 77 units with worldwide distribution, including US nationwide distribution and markets in APAC, Canada, EMEA, and LATAM. Affected lot numbers are 32753933, 32937357, 32987960, and 33218763.
Healthcare providers using these devices should review patient records for affected lot numbers and contact Boston Scientific for guidance on managing patients with these devices.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV LL 23X155- 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
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: 08714729905578 Lot Numbers: 32753933
- 32937357
- 32987960
- 33218763
Distribution
Distributed nationwide across the United States.
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