Z-1397-2023 Class II Ongoing
FDA device recall Z-1397-2023 was initiated by Boston Scientific Corporation on February 2, 2023 and is designated Class II. Reason for recall: Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccu… The recall status is ongoing. Affected quantity: 6635 units US: 1815 US units; 4820 OUS units.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- February 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6635 units US: 1815 US units; 4820 OUS units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Iraq, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Unit. Arab Emir.