Habib™ EndoHPB Catheter
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
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