Device type
Temporary Non-Roller Type Left Heart Support Blood Pump
Product code OZD · Class III · Unknown
A blood pump that provides temporary full or partial left heart support
Recent 510(k)s
No 510(k) clearances in the archive for OZD.
Recent recalls
Nov 4, 2026
Z-0208-2027
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Nov 4, 2026
Z-0209-2027
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Nov 4, 2026
Z-0210-2027
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Sep 30, 2026
Z-3251-2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042…
Abiomed, Inc.
- OZD
- Class II
- Ongoing
Sep 23, 2026
Z-3150-2026
Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optic…
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Sep 23, 2026
Z-3148-2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042…
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Sep 23, 2026
Z-3149-2026
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042…
Abiomed, Inc.
- OZD
- Class I
- Ongoing