Recall Z-3149-2026— Abiomed, Inc.
Class I · Ongoing
Class I FDA medical device recall by Abiomed, Inc., initiated 2026-08-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.. Reason: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-08-12
- Firm location
- Danvers, MA, United States
Product description
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.
Reason for recall
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.