Esophageal Stent System Recalled Due to Potential Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.
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: FDA Class II medical device with potential for delivery catheter tip detachment. No reported injuries, hospitalizations, or deaths. The source describes a risk-of-harm product where injury has not yet been reported, meeting the criteria for score 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling the WallFlex Esophageal Stent System and the Agile Esophageal Over the Wire (OTW) Stent System. These devices are intended to maintain esophageal luminal patency in esophageal strictures caused by malignant tumors or fistulas.
The recall is due to the potential for delivery catheter tip detachment. Approximately 305 units were distributed worldwide, including across the United States, Asia-Pacific, Canada, Europe/Middle East/Africa, and Latin America.
Healthcare providers and patients who have received these stent systems should contact Boston Scientific Corporation for guidance. Multiple lot numbers of the WallFlex system are affected, including batches 32759900, 32759903, 32789717, 32789718, 32829629, 32847692, 32848481, 32898067, 32919347, 32927195, 32949480, 32956257, 32957302, 32965072, 32985475, 32987961, 33047928, 33145976, 33145978, 33208046, 33208048, 33242626, and 33275535.
The recalled product
- Product
- WALLFLEX PC ESOPH STENT 23/28MM X 125MM- 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
- device-component-detachment
- device-failure
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 (16)
- GTIN: 08714729765288 Lot Numbers: 32759900
- 32759903
- 32789717 32789718
- 32829629
- 32847692 32848481
- 32898067
- 32919347 32927195
- 32949480
- 32956257 32957302
- 32965072
- 32985475 32987961
- 33047928
- 33145976 33145978
- 33208046
- 33208048 33242626
- 33275535
Distribution
Distributed nationwide across the United States.
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