Reported Apr 26, 2023 · Ongoing
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts
- UPNM00500070
- Lot codes and dates
- GTIN8714729981909 All lots , All Expiration Dates
- Amount recalled
- 6635 units US: 1815 US units; 4820 OUS units
Where it was sold
- Nationwide
Why it was recalled
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 inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").
This product could cause temporary or reversible health problems — stop using it.
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