FDA Device recall Z-0887-2022
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001 by Maquet Cardiovascular, citing potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0887-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-09 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Cardiovascular |
| Distribution | AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI |
Product
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Reason
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
Identifiers
| code_info | UDI# 00607567700901, Lots (3): 25153700, 25157489, 25158616. Please note affected lot numbers (25153700, 25157489, 2515…UDI# 00607567700901, Lots (3): 25153700, 25157489, 25158616. Please note affected lot numbers (25153700, 25157489, 25158616) appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number (200501), which is etched onto all 3 device components on side of handle and on underside above each pin. |
|---|
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-0887-2022%22
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