Abbott Amplatzer Steerable Delivery Sheath — Class I medical device recall Z-2110-2023
Ongoing recall by Abbott, reported 2023-07-19, distributed nationwide. There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during proc
| Recall number | Z-2110-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Plymouth, MN, United States |
| Recall initiated | 2023-06-12 |
| Classified | 2023-07-11 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, SK |
| Quantity | 675 units |
| UPC / GTIN / UDI-DI | 05415067036025 |
| Lot numbers | 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835 |
| Model numbers | ASDS-14F-075 |
Product
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
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.
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-2110-2023. 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.