Recall Z-0676-2024 ยท PDU Catheter For Crossing Total Occlusions
Bard Peripheral Vascular Inc
BD Recanalization System, REF: BDRECANSYSTEM
| Date | Jan 5, 2024 (initiated Nov 14, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| Action | On 11/14/23 recall notices were mailed and emailed to customers who were asked to do the following: 1) Discontinue use of affected product and immediately quarantine until ready to return for service activities. 2) Share this notification with all device users within your facility and network to ensure they are aware of this field action. This notification should also be shared with any organization where the potentially affected devices have been transferred. 3) Complete and return the response form via email to BDRC49@bd.com 4) Recalling firm will contact customers to coordinate product ret |
| Quantity | 403 |
| Distribution | US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA, NM, CO, KY, ME, MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203363 | Crosser iQ CTO Recanalization System C.R. Bard, Inc., Aug 12, 2021 |