Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 10 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, which indicates a risk of temporary or medically reversible adverse health consequences. The hazard involves a mechanical defect (catheter tip detachment) in a medical device where no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Boston Scientific Corporation is recalling the Agile Esophageal Partially Covered (PC) and Fully Covered (FC) Over the Wire (OTW) Stent System. The recall is due to the potential for the delivery catheter tip to detach. The affected product is the AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F, with Material Number M00517800.
The recall involves 10 units of the device. The product was distributed worldwide, including the United States, APAC, Canada, EMEA, and LATAM regions. The specific lot number is 33005087, and the GTIN is 00191506006679.
The FDA has classified this recall as Class II. This classification indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Healthcare providers and patients should contact Boston Scientific for further instructions regarding the affected devices.
The recalled product
- Product
- AGILE ESO FC RMV 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
- 10
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: 00191506006679 Lot Numbers: 33005087
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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