Boston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment
Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.
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: This is a Class II FDA medical device recall with a theoretical hazard (potential delivery catheter tip detachment) and no reported injuries, illnesses, or deaths. Per the severity rubric, risk-of-harm products without reported injury are classified as High (3).
Plain-English summary
Boston Scientific Corporation is recalling the Agile Esophageal Over-the-Wire (OTW) Stent System. This esophageal stent maintains esophageal patency in patients with malignant tumor-related strictures or concurrent esophageal fistulas.
The recall is due to the potential for delivery catheter tip detachment. Seven units with lot numbers 32889020 and 33178844 (GTIN 00191506006662) are affected, distributed worldwide including the United States, APAC, Canada, EMEA, and LATAM regions.
Healthcare providers and patients should be aware of this recall and should contact Boston Scientific Corporation for information regarding affected units.
The recalled product
- Product
- AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-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
- Hazard
- Affected units
- 7
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: 00191506006662 Lot Numbers: 32889020
- 33178844
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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