Recall Monitor
Health Products

Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Hot AXIOS™ Stent and Electrocautery Enhanced Delivery SystemMore than 10 numbers, contact manufacturer.M00553520
M00553570
M00553550
M00553530
M00553540
M00553560

Issue

Boston Scientific is initiating a removal of specific lots of the AXIOS™ Stent and Electrocautery Enhanced Delivery System due to reports of the outer sheath distal black tip detaching from the device. Boston Scientific has received seven (7) reports of this issue between June 1, 2023, and present day. Recall start date: December 20, 2024

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