Product Wiki · Recalls · Health Canada — Medical Devices

Habib™ EndoHPB Catheter — recall 73336

Health Canada — Medical Devices · Canada · 2023-03-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
73336
Date of alert
2023-03-16
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Obstetrics and gynaecology
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/habibtm-endohpb-catheter

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