Wallflex and Agile Esophageal Stent Systems Recalled for Potential Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment. The recall affects 39 units distributed worldwide.
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: Class II medical device recall for potential delivery catheter tip detachment with no reported injuries or illnesses. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Boston Scientific has recalled the WallFlex Esophageal Stent System and Agile Esophageal Over-the-Wire (OTW) Stent System. These devices are intended to maintain open esophageal passages in patients with strictures caused by malignant tumors or concurrent esophageal fistulas.
The recall was initiated due to the potential for delivery catheter tip detachment during device placement.
The recall affects 39 units distributed worldwide, including the United States and regions such as Asia-Pacific, Canada, Europe/Middle East/Africa, and Latin America. The affected lot numbers are: 32965060, 33077153, 33120914, and 33266650.
The recalled product
- Product
- WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is 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
- 39
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: 08714729765264 Lot Numbers: 32965060
- 33077153
- 33120914
- 33266650
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.
See all 31 products in this recall →Related recalls
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Same hazard · catheter detachment
See all →- HighBoston Scientific Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- SevereBoston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- HighBoston Scientific Recalls WallFlex Esophageal Stents Due to Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- HighBoston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- HighBoston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk
FDA (Devices) · 2024-10-02
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