Habib™ EndoHPB Catheter
Brand(s)
Last updated
Summary
Product
Habib™ EndoHPB Catheter
Issue
Medical devices - Device compatibility
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Habib™ EndoHPB Catheter |
All lots. |
M00500070 |
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
Additional information
Details
Original published date: 2023-03-16
Alert / recall type
Health product recall
Category
Health product - Medical device - Obstetrics and gynaecology
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73336