Habib EndoHPB Bipolar RF Catheter Recalled Due to Thermal Injury Risk
Boston Scientific recalls the Habib EndoHPB Bipolar RF Catheter used in pancreatic and biliary procedures due to inaccurate instructions that could result in excessive energy delivery and thermal injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with risk of thermal injury and tissue damage, but no reported illnesses or injuries. Meets the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm), a device used for ablation procedures in the pancreatic and biliary tracts. The recall affects approximately 6,635 units distributed worldwide, including 1,815 units in the United States.
The device is being recalled due to an inaccurate setting in the device's Instructions for Use (IFU). This inaccuracy creates a risk of delivering excessive radiofrequency energy, which could result in thermal injury or tissue damage to patients during procedures.
The Habib EndoHPB Bipolar RF Catheter is used with the ERBE VIO3 Generator. Immediate cessation of use is required.
The recalled product
- Product
- 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. UPN: M00500070
- Manufacturer
- Boston Scientific Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 8714729981909 All lots
- All Expiration Dates
Distribution
Distributed nationwide across the United States.
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