Boston Scientific recalls Habib EndoHPB Bipolar RF Catheters due to potential thermal injury from excessive energy delivery. Affected units have specific model and lot numbers; stop using immediately to prevent tissue damage.
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").
Boston Scientific is recalling Habib EndoHPB Bipolar RF Catheters that could cause thermal injury if used improperly. This recall is critical because the device's instructions may provide inaccurate settings, risking serious tissue damage during medical procedures.
The catheter's instructions for use contain an inaccurate setting that could deliver excessive radiofrequency energy. This may cause thermal injury or tissue damage during medical procedures, particularly in the pancreas or bile ducts.
Patients undergoing pancreatic or biliary procedures who use the Habib EndoHPB Bipolar RF Catheter are most at risk. Healthcare providers who have the device in their inventory or on hand for procedures should also stop using it immediately.
Check for the Habib EndoHPB Bipolar RF Catheter 8F (2.7mm) model. All lots and all expiration dates are affected. The product is sold under the UPN code M00500070 and GTIN 8714729981909.
Cease using the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator to prevent thermal injury or tissue damage.
The recall is due to an inaccurate setting in the device's instructions for use that could deliver excessive radiofrequency energy, leading to thermal injury or tissue damage.
All lots of the Habib EndoHPB Bipolar RF Catheter 8F (2.7mm) are affected, with the UPN code M00500070 and GTIN 8714729981909.
The official recall does not mention a fix; the remedy is to stop using the device immediately to prevent harm.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1397-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1397-2023 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
