Esophageal Stent Systems Recalled for Potential Delivery Catheter Detachment
Boston Scientific is recalling esophageal stent systems due to potential delivery catheter tip detachment during placement. Patients and providers with affected devices should contact the manufacturer for guidance.
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 medical device recall for potential mechanical failure (delivery catheter tip detachment) during a critical clinical procedure. Classified as a risk-of-harm product where loss of device functionality could lead to serious patient injury.
Plain-English summary
Boston Scientific Corporation is recalling AGILE ESO OTW PC and WALLFLEXTM Esophageal Stent Systems due to the potential for delivery catheter tip detachment during stent placement. These medical devices are used to maintain esophageal patency in patients with strictures caused by malignant tumors and esophageal fistulas.
The affected lot number is 33178843 (6 units total). The stent systems have been distributed worldwide, including throughout the United States and regions in APAC, Canada, EMEA, and LATAM.
Patients who have received these stent systems and healthcare providers with affected inventory should contact Boston Scientific for guidance regarding management of the recalled devices.
The recalled product
- Product
- AGILE ESO OTW PC 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
- 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 (1)
- GTIN: 00191506006587 Lot Numbers: 33178843
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.
See all 31 products in this recall →Related recalls
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