Recall
Class I — Abbott
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| Product | Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac). |
| Quantity | 675 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic. |
| Initiated | 2023-06-12 |
| Classified | 2023-07-11 |
| Recall number | Z-2110-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Abbott (Z-2110-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92502/
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