Recall Z-0090-2021 ยท OBJ Catheter, Ultrasound, Intravascular
Siemens Medical Solutions USA, Inc.
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
| Date | May 22, 2020 |
| Status | Terminated |
| Reason | Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block. |
| Root cause | Under Investigation by firm |
| Action | On 05/22/2020, the firm notified customers via telephone of the recall and send on 05/26/2020 an email with an attached "URGENT SAFETY ADVISORY NOTIFICATION" Letter inform customer that the Recalling Firm has received reports of left atrial perforations and Atrioventricular Node block occurring while using the affected product. The customer notification instructs customers to: -Immediately stop performing procedures using the affected catheters and segregate the product. -All remaining affected inventory in their possession will be collected. The following steps outline the sequence of this p |
| Distribution | U.S.: AZ, CA, FL, GA, IL, KY, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TX, VA, WA and WV. O.U.S; Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173618 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Siemens Medical Solutions USA, Inc., Dec 19, 2017 |