Esophageal Stent Systems Recalled Due to Catheter Detachment Risk
Boston Scientific is recalling Wallflex and Agile esophageal stent systems worldwide due to the potential for delivery catheter tip detachment during placement. The recall affects 133 units distributed globally.
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 recall of a medical device with potential for serious harm from catheter tip detachment during esophageal stent placement. The source text does not report any injuries, deaths, or hospitalizations. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
Boston Scientific Corporation is recalling the Wallflex Esophageal Stent System and Agile Esophageal Over-the-Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. These devices are used to maintain esophageal patency in patients with strictures caused by malignant tumors or esophageal fistulas. A total of 133 units are affected by this recall.
The devices have been distributed worldwide, including throughout the United States, Asia-Pacific, Canada, Europe, Middle East and Africa, and Latin America. Healthcare providers using or patients who have received these devices should verify the lot numbers of their devices against those identified in the recall.
Affected lot numbers are: 32770265, 32799938, 32799939, 32809371, 32809372, 32957301, 33128874, 33156073, 33156074, 33156075, 33156076, 33233491, and 33233492. Patients and healthcare providers are advised to contact Boston Scientific for information regarding this recall.
The recalled product
- Product
- WALLFLEX PC ESOPH STENT 23/28MM X 105MM- 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
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 (9)
- GTIN: 08714729765271 Lot Numbers: 32770265
- 32799938
- 32799939 32809371
- 32809372
- 32957301 33128874
- 33156073
- 33156074 33156075
- 33156076
- 33233491 33233492
Distribution
Distributed nationwide across the United States.
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