Public recall detail

Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System

2025-01-08

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Recall Safety notice
Quick summary

Quick summary: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System. Date: 2025-01-08.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System. Date: 2025-01-08.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBOSTON SCIENTIFIC CORPORATION
ProductHot AXIOS™ Stent and Electrocautery Enhanced Delivery System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76806

Affected products

ProductHot AXIOS™ Stent and Electrocautery Enhanced Delivery System
LotMore than 10 numbers, contact manufacturer.
ModelM00553520 M00553570 M00553550 M00553530 M00553540 M00553560
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHot AXIOS™ Stent and Electrocautery Enhanced Delivery System

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesBoston Scientific Corporation 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76806
Background{}
CompaniesBoston Scientific Corporation 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
AudiencesHealthcare
Source updated2025-01-08

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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