Amplatzer Steerable Delivery Sheath — Class II medical device recall Z-0895-2022
Terminated recall by Abbott, reported 2022-04-13. Instructions for use were updated.
| Recall number | Z-0895-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Plymouth, MN, United States |
| Recall initiated | 2021-11-09 |
| Classified | 2022-04-07 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2024-08-07 |
| Quantity | 529 units |
| Model numbers | ASDS-14F-075 |
Product
Amplatzer Steerable Delivery Sheath
Reason for recall
Instructions for use were updated.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0895-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.