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.
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 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 esophag
- Manufacturer
- Boston Scientific Corporation
- Hazard
- catheter-tip-detachment
- device-malfunction
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.
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