Recall Z-2110-2023
Abbott · initiated June 12, 2023
Class I – dangerous or defective products that could cause serious health problems or death
Product
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Codes / lots: UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-2110-2023
- Initiated
- June 12, 2023
- Posted by FDA
- July 11, 2023
- Product code
- DQY – Catheter, Percutaneous
- Quantity
- 675 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
- Recalling firm
- Abbott, Plymouth, MN