Drug recall
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides…
FDA recall event 91792 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 91792 |
|---|---|
| Recall numbers | Z-1397-2023 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 2, 2023 |
| Report date | Apr 26, 2023 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 3005099803 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: