Esophageal stent systems recalled due to delivery catheter tip detachment risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement 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 medical device recall for a potential equipment malfunction (catheter tip detachment) during a critical medical procedure. No illnesses or injuries have been reported, but the hazard poses a risk of patient harm.
Plain-English summary
The WallFlex Esophageal Stent System and Agile Esophageal Over the Wire (OTW) Stent System are being recalled by Boston Scientific Corporation. These stent systems are intended for maintaining esophageal luminal patency in patients with esophageal strictures caused by malignant tumors, and for occlusion of concurrent esophageal fistulas.
The recall affects 40 units with lot numbers 32771052 and 32846905. These devices have been distributed worldwide, including throughout the United States and to facilities in APAC, Canada, EMEA, and LATAM regions.
The recall was initiated due to the potential for delivery catheter tip detachment during stent placement. This could interfere with proper device deployment and function.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516300
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 40
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 (2)
- GTIN: 08714729905554 Lot Numbers: 32771052
- 32846905
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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