Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
- Company
- Abbott
- Recall Initiated
- June 12, 2023
- Posted
- July 11, 2023
- Recall Number
- Z-2110-2023
- Quantity
- 675 units
- Firm Location
- Plymouth, MN
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
Lot / Code Info
UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
Root 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.