Bard Peripheral Vascular Inc recalled The EVSRF catheter on Sept. 4, 2024, after the FDA announced the sterile, single-use medical device may deliver excessive heat due to an internal wiring error. Owners should contact the company for a remedy.
How to tell if you have it
- Brand: Bard Peripheral Vascular
- Product: The EVSRF catheter
- Catalog Number: VC-10A2.5-6F-100
- Catalog Number: VC-10A2.5-6F-60
- Catalog Number: VC10A256F100
- Catalog Number: VC10A256F60
- Catalog Number: VCOUS6F100
- Catalog Number: VCOUS6F60
- UPC: 00858254006008
- UPC: 00858254006015
- UPC: 00858254006244
- UPC: 00858254006251
The hazard
The Venclose RF Ablation Catheters may have been manufactured with internal wiring error where red and yellow signal wires were soldered on swapped ports. This causes the generator to overdrive the catheter, reaching temperatures exceeding intended levels while falsely indicating the target temperature has not been reached.
Context
GovInfoNow's records show Bard Peripheral Vascular Inc has 40 other recalls on record since 2017-09-22. Other recent recalls include a Bard Breast Biopsy System recall on 2026-08-20, a Broviac Cutdown Trays recall on 2025-12-12, and a Safe-T-Centesis Catheter Drainage Tray recall on 2025-11-06. Similar product recalls include Bard PowerMidline Catheter and PowerPICC Catheters recalls on 2026-05-21.