Esophageal stent system recalled due to potential delivery catheter detachment
Boston Scientific is recalling Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment that could affect proper stent deployment during medical procedures.
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 for a device with potential for malfunction (catheter tip detachment) that could impact proper stent deployment. No illnesses or injuries are reported in the source documentation, fitting the rubric criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the Wallflex FC ESO Esophageal Stent System due to the potential for the delivery catheter tip to detach. This stent is intended to maintain esophageal luminal patency (openness) in patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors or esophageal fistulas.
If the catheter tip detaches during the delivery procedure, the stent may not be placed properly in the esophagus, potentially requiring additional intervention.
Approximately 79 units with lot numbers 33045962, 33120912, 33137308, 33208045, and 33245087 are affected. These units have been distributed worldwide. The material number is M00516210 (GTIN: 08714729854470).
Healthcare facilities and clinicians should contact Boston Scientific for information about this recall and next steps for affected devices.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV 18X103MM- 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-detachment
- stent-delivery-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 (5)
- GTIN: 08714729854470 Lot Numbers: 33045962
- 33120912
- 33137308
- 33208045
- 33245087
Distribution
Distributed nationwide across the United States.
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