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 17 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. 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, and the hazard involves a structural defect in a medical device (catheter tip detachment) which poses a significant risk of injury during use.
Plain-English summary
Boston Scientific Corporation is recalling the Agile Esophageal Over the Wire (OTW) Stent System, specifically the 23mm x 12.0cm 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 17 units with Lot Number 33005086 and GTIN 00191506006600. These devices were distributed worldwide, including the United States, Canada, and regions in APAC, EMEA, and LATAM. The agency has classified this as a Class II recall.
Healthcare providers and patients should contact Boston Scientific Corporation for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- AGILE ESO OTW PC 23MM X 12.0CM 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 concu
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 17
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: 00191506006600 Lot Numbers: 33005086
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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