Boston Scientific esophageal stents recalled due to catheter tip detachment risk
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential detachment of the delivery catheter tip during stent placement. These devices are used to maintain patency in esophageal strictures caused by malignant tumors or esophageal fistulas.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 of a medical device used in sensitive esophageal procedures. Although the hazard—delivery catheter tip detachment—could potentially cause serious injury if it occurs, no illnesses or injuries have been reported. The risk is characterized as potential rather than realized harm.
Plain-English summary
Boston Scientific Corporation is recalling esophageal stent systems—specifically the Wallflex Esophageal Stent System (in partially covered and fully covered versions) and the Agile Esophageal Over the Wire (OTW) Stent System. These devices are intended to maintain esophageal luminal patency in strictures caused by malignant tumors or esophageal fistulas.
The recall is due to the potential for delivery catheter tip detachment during stent placement. If the catheter tip detaches during insertion, it could remain in the esophagus and potentially cause harm.
The affected devices were distributed worldwide, including throughout the United States, Asia-Pacific region, Canada, Europe, Middle East, Africa, and Latin America. The specific affected Wallflex lot number is 33094174.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV 18X153MM-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
- Affected units
- 2
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 (1)
- GTIN: 08714729854494 Lot Numbers: 33094174
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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See all →- HighBoston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment
FDA (Devices) · 2024-10-02
- HighEsophageal Stent Systems Recalled Due to Catheter Detachment Risk
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- HighBoston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment
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- HighWallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment
FDA (Devices) · 2024-10-02
- HighWallFlex and Agile Esophageal Stent Systems Recalled for Catheter Tip Detachment
FDA (Devices) · 2024-10-02
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