Public recall detail

Habib™ EndoHPB Catheter

2023-03-16

medium
Recall Safety notice
Quick summary

Quick summary: Habib™ EndoHPB Catheter. Date: 2023-03-16.

Recommended action

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

Recall details

Quick summary: Habib™ EndoHPB Catheter. Date: 2023-03-16.

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
ProductHabib™ EndoHPB Catheter
IssueMedical devices - Device compatibility Medical devices - Performance
Recall classType II
IdentificationRA-73336

Affected products

ProductHabib™ EndoHPB Catheter
LotAll lots.
ModelM00500070
Serial numberAll lots.
DescriptionHabib™ EndoHPB Catheter

Issue

During investigational testing of the Habib™ Catheter with the ERBE VIO 3 generator (compatible 3rd party device), an issue with the generator setting in the Habib™ IFU (50738103) was identified. From the results of this testing, it was determined that the VIO 3 setting produces results that do not meet the dimensional requirements identified for the ablation heating zone in the Habib™ design matrix (92252607). Recall start date: March 2, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Obstetrics and gynaecology
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-73336
Background{}
CompaniesBoston Scientific Corporation 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
AudiencesHealthcare
Source updated2023-03-16

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

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...