Recall Z-0676-2024— Bard Peripheral Vascular Inc
Class II · Ongoing
Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2023-11-14. It names one FDA 510(k) clearance: K203363. Product: BD Recanalization System, REF: BDRECANSYSTEM. Reason: 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..
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-14
- Firm location
- Tempe, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BD Recanalization System, REF: BDRECANSYSTEM
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.