Venclose RF Ablation Catheters Recalled for Wiring Defect Causing Excessive Heat
Bard Peripheral Vascular's Venclose RF ablation catheters may have swapped signal wires causing excessive heating. The defect can lead to temperatures exceeding therapeutic levels, increasing risk of 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: This FDA Class II recall involves a manufacturing defect causing the device to exceed therapeutic temperatures without reported injuries. This constitutes a risk-of-harm product without actualized injury, meeting the High severity criterion per the rubric.
Plain-English summary
The Venclose RF Ablation Catheter is a sterile, single-use medical device used to treat refluxing veins through endovenous radiofrequency ablation. The device uses a heating element powered by a radiofrequency generator to permanently eliminate diseased veins. Approximately 222,373 affected catheters were distributed worldwide.
The recalled catheters contain an internal manufacturing error in which the red and yellow signal wires were soldered to the wrong ports on the catheter's circuit board. This wiring error causes power to flow through the proximal three-quarters of the heating coil while bypassing the temperature sensor (thermocouple).
As a result, the device heats to temperatures exceeding the intended 120°C therapeutic level. The control console displays an inaccurate temperature reading, indicating the target has not been reached while the device is actually overheating. This increases the risk of thermal injury to veins and surrounding tissue.
No injuries have been reported in connection with these devices to date.
The recalled product
- Product
- The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- wiring-error
- excessive-temperature
- burn-injury
Distribution
Distributed nationwide across the United States.
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