WallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.
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 medical device recall with a functional defect (delivery catheter tip detachment) that represents a risk of harm during esophageal stent placement. However, no injuries or hospitalizations have been reported in the recall notice, meeting the rubric criterion for score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling WallFlex Esophageal Stent System and Agile Esophageal Over the Wire (OTW) Stent System due to potential for delivery catheter tip detachment during insertion. These devices are used to maintain esophageal luminal patency in patients with esophageal strictures caused by malignant tumors and concurrent esophageal fistulas.
A total of 199 units have been distributed worldwide with global scope including the United States, Asia-Pacific, Canada, Europe/Middle East/Africa, and Latin America. Multiple lot numbers are affected in this recall.
The recalled product
- Product
- WALLFLEX PC ESOPH STENT 23/28MM X 155MM- 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
- Affected units
- 199
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 (11)
- GTIN: 08714729765295 Lot Numbers: 32764205
- 32764206
- 32827703 32837016
- 32837017
- 32850357 32869530
- 32876613
- 32891019 32900187
- 32938379
- 33145977 33160189
- 33167134
- 33242627
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 tip detachment
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
FDA (Devices) · 2024-10-02
- HighBoston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- HighBoston Scientific esophageal stents recalled due to catheter tip detachment risk
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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