Boston Scientific Agile Esophageal Stent Recall: Catheter Tip Detachment Risk
Boston Scientific is recalling Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The Class II recall affects 6 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with no reported illnesses or deaths. The hazard—potential delivery catheter tip detachment during esophageal stent placement—represents a risk of harm to patients during a critical medical procedure, but no adverse events have been reported. This meets the 'High' severity threshold for risk-of-harm medical devices without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling the Agile Esophageal Partially Covered (PC) and Fully Covered (FC) Over-the-Wire (OTW) Stent System. This medical device is used to maintain esophageal patency in patients with strictures caused by malignant tumors or to manage esophageal fistulas. The affected lot numbers are 32889021 and 33178845, with 6 units identified. The product has been distributed worldwide, including the United States, APAC, Canada, EMEA, and LATAM regions.
The FDA classified this as a Class II recall due to the potential for delivery catheter tip detachment. If the catheter tip detaches during stent placement, it could compromise the delivery mechanism and potentially cause patient harm.
Healthcare providers should identify and quarantine any units bearing lot numbers 32889021 or 33178845. Patients or healthcare providers with questions or concerns should contact Boston Scientific Corporation.
The recalled product
- Product
- AGILE ESO FC RMV 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…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 6
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 (2)
- GTIN: 00191506006693 Lot Numbers: 32889021
- 33178845
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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