FDA Device recall Z-0895-2022
Amplatzer Steerable Delivery Sheath
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Amplatzer Steerable Delivery Sheath by Abbott, citing instructions for use were updated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0895-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-09 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott |
| Distribution | n/a |
Product
Amplatzer Steerable Delivery Sheath
Reason
Instructions for use were updated.
Identifiers
| code_info | Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102…Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0895-2022%22
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