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.
What this means for you
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.
Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
Same hazard · thermal injury
See all →- HighCASE cardiac testing systems may spark at the printer head
FDA (Devices) · 2026-06-10
- HighEndoscopy video processors recalled over hot light guide and thermal injury risk
FDA (Devices) · 2025-08-27
- HighVideo Colonoscope May Cause Thermal Burns to Tissue During Use
FDA (Devices) · 2025-03-05
- HighStryker iBur Surgical Bur Recall Due to Excessive Heat Risk
FDA (Devices) · 2024-09-04
- HighStryker iBur 3.0mm surgical burr recalled over thermal hazard
FDA (Devices) · 2024-09-04