FDA Device recall Z-2110-2023
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac)
- FDA Device
- Class I
- ongoing
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class I recall of Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac) by Abbott, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2110-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-06-12 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott |
| Distribution | US |
Product
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
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.
Identifiers
| code_info | UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2110-2023%22
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