Boston Scientific Esophageal Stent Systems Recalled for Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems for potential delivery catheter tip detachment during insertion. Eighteen units were distributed worldwide including the United States.
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 a Class II FDA recall involving medical devices where delivery catheter tip detachment could result in patient harm or improper stent placement. However, no illnesses or injuries are reported, and the hazard is described as potential rather than confirmed. Per the rubric, when no illnesses are reported and the hazard is theoretical, the score is at most 3.
Plain-English summary
Boston Scientific Corporation is recalling two esophageal stent systems: the WallFlex Esophageal Stent System and the Agile Esophageal Over-the-Wire (OTW) Stent System. These devices maintain esophageal patency in patients with strictures caused by malignant tumors or concurrent esophageal fistulas.
The recall addresses the potential for delivery catheter tip detachment. This defect could occur during device insertion and may impact proper stent placement.
Eighteen units with lot number 33005085 were distributed worldwide, including the United States and the Asia-Pacific, Canadian, European, Middle Eastern, African, and Latin American markets. Further information is available from the FDA and Boston Scientific Corporation.
The recalled product
- Product
- AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 18
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: 00191506006631 Lot Numbers: 33005085
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 Esophageal Stents Recalled for Catheter Tip Detachment Risk
FDA (Devices) · 2024-10-02
- HighBoston Scientific recalls WallFlex and Agile esophageal stents for delivery catheter detachment
FDA (Devices) · 2024-10-02
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