Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 15 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: The recall is classified as FDA Class II. The hazard involves a mechanical failure (catheter tip detachment) in a medical device, which poses a risk of harm, but the source does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the Agile Esophageal Over the Wire (OTW) Stent System, specifically the 23mm x 10.1cm in 18.5F model. The recall is due to the potential for the delivery catheter tip to detach. The affected product is intended for maintaining esophageal luminal patency in esophageal strictures caused by malignant tumors and occlusion of concurrent esophageal fistulas.
The recall involves 15 units with Lot Number 33215327 and GTIN 00191506006594. These devices were distributed worldwide, including the United States, Canada, and regions in APAC, EMEA, and LATAM.
Healthcare providers and patients should stop using the affected devices and contact Boston Scientific for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AGILE ESO OTW PC 23MM X 10.1CM 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
- 15
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: 00191506006594 Lot Numbers: 33215327
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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