Wallflex and Agile Esophageal Stent Systems Recalled Due to Catheter Tip Detachment Risk
Boston Scientific is recalling the Wallflex Esophageal Stent System and Agile Esophageal Over the Wire Stent System due to potential delivery catheter tip detachment during placement. Wallflex devices totaling 115 units are affected.
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 recall of delivery-dependent medical devices with potential for catheter tip detachment. No illnesses or injuries have been reported, but this hazard represents a risk of harm during esophageal stent placement in vulnerable patients.
Plain-English summary
Boston Scientific Corporation is recalling the Wallflex Esophageal Stent System and the Agile Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment during placement.
The Wallflex Esophageal Stent System is designed to maintain esophageal luminal patency in patients with esophageal strictures caused by malignant tumors or esophageal fistulas. The Wallflex recall affects 115 units with lot numbers: 32858862, 32865977, 32898069, 32914769, 32985474, and 33256092.
The recall is due to the potential for delivery catheter tip detachment during the stent placement procedure. This delivery mechanism defect could compromise the safety and efficacy of the placement procedure.
The recalled devices have been distributed worldwide, including throughout the United States and to countries in APAC (Asia-Pacific), Canada, EMEA (Europe, Middle East, Africa), and LATAM (Latin America). Healthcare facilities and clinicians should stop using affected lot numbers immediately and contact Boston Scientific for guidance on device replacement and patient management.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
- Manufacturer
- Boston Scientific Corporation
- Hazard
- catheter-tip-detachment
- delivery-system-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 (6)
- GTIN: 08714729905561 Lot Numbers: 32858862
- 32865977
- 32898069
- 32914769
- 32985474
- 33256092
Distribution
Distributed nationwide across the United States.
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