Esophageal stent systems recalled due to delivery catheter defect
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
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 a medical device with risk-of-harm due to delivery catheter tip detachment during deployment; no reported illnesses or injuries documented in source material.
Plain-English summary
Boston Scientific Corporation is recalling AGILE ESO OTW PC and WallFlex Esophageal Stent Systems due to the potential for delivery catheter tip detachment during deployment. These devices are intended to maintain esophageal luminal patency in patients with esophageal strictures caused by malignant tumors or concurrent fistulas.
The recalled products have a defect that could result in the catheter tip detaching from the device during the deployment procedure. This defect could affect proper stent placement and function.
The recalled stent systems were distributed worldwide, including throughout the United States and internationally to APAC, Canada, EMEA, and LATAM regions. The affected lot number is 33005084.
Patients and healthcare providers should discontinue use of the affected lot and contact Boston Scientific for instructions regarding replacement or return of the recalled devices.
The recalled product
- Product
- AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
- Manufacturer
- Boston Scientific Corporation
- Hazard
- catheter-tip-detachment
- delivery-system-defect
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 (1)
- GTIN: 00191506006617 Lot Numbers: 33005084
Distribution
Distributed nationwide across the United States.
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