Bard Peripheral Vascular, Inc.PDUClass II

Catheter For Crossing Total Occlusions

Bard Peripheral Vascular, Inc.'s record for this product code

MDR events1,022All time

Recalls1All time

510(k) clearances0All time

Recent MDR events

1,022 adverse event reports on file

Recalls

1 recall events for this product code

Open, ClassifiedJan 5, 2024
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
View FDA record ↗

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for Bard Peripheral Vascular, Inc. under this product code.