Recall Z-2110-2023 ยท DQY Catheter, Percutaneous
Abbott
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
| Date | Jul 11, 2023 (initiated Jun 12, 2023) |
| Status | Open, Classified |
| Reason | There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used. |
| Root cause | Device Design |
| Action | Abbott issued a MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023. The notice explained the problem with the device, the risk, and requested the return of all units. Should you have questions about this issue, please contact your local Abbott Representative or Abbott Support at 1-800-544-1664 (Option 2) (U.S.), 7:00 a.m. - 7:00 p.m. Central Time, Monday through Friday. |
| Quantity | 675 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220340 | Amplatzer Steerable Delivery Sheath ABBOTT MEDICAL, Mar 9, 2022 |