Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
FDA device recall Z-2110-2023 · posted 2023-07-11 · Open, Classified
Recall details
- Recalling firm
- Abbott
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DQY
- Quantity affected
- 675 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
- Date initiated
- 2023-06-12
- Date posted
- 2023-07-11
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Amplatzer Steerable Delivery Sheath (K220340) | ABBOTT MEDICAL | 2022-03-09 |