Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
Boston Scientific is recalling Agile Esophageal Over the Wire Stent Systems because the delivery catheter tip may detach. The recall affects 19 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for device malfunction (catheter tip detachment) in a medical context.
Plain-English summary
Boston Scientific Corporation is recalling the Agile Esophageal Over the Wire (OTW) Stent System, specifically the 23mm x 15.0cm in 18.5F configuration. 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 19 units of the product, identified by GTIN 00191506006655 and Lot Number 33266651. These units were distributed worldwide, including the United States, APAC, Canada, EMEA, and LATAM regions.
Healthcare providers and patients should contact Boston Scientific for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- AGILE ESO OTW FC 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
- 19
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: 00191506006655 Lot Numbers: 33266651
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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