Recall Z-3149-2026
Abiomed, Inc. · initiated August 12, 2026
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.
Codes / lots: 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU; UDI-DI: 00813502010930; Serial Numbers: IC5130, IC5131; 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU; UDI-DI: 00813502010961; Serial Numbers: IC12955, IC12978, IC13013, IC13027, IC13042, IC13202, IC13223, IC13228, IC6947, IC6948, IC7625, IC7740, IC7741, IC8064, IC8065, IC8157, IC8158, IC8419, IC8727, IC7937, IC7940, IC9356, IC9363, IC9365, IC9369, IC9370, IC9371, IC9832, IC9833, IC5409, IC7794, IC7795, IC7796, IC7798, IC7799, IC7800, IC7945, IC7946, IC8069, IC8070, IC8263, IC8337, IC8341, IC8343, IC8441, IC8445, IC8447, IC8448, IC8449, IC8451, IC8861, IC9025, IC9028, IC9366, IC9799, IC8476A, IC9181A, IC13190, IC13205, IC9031, IC9094, IC9801, IC9865, IC9867, IC9973, IC7825, IC9095, IC8032, IC8126, IC8629, IC8630, IC8640, IC8641, IC9364, IC9368, IC9804, IC9805, IC9834, IC9835, IC8388, IC8751, IC9501, IC9972, IC10035, IC7629, IC7636, IC8164, IC8683, IC5592, IC6277, IC7046, IC7637, IC7638, IC7639, IC7640, IC7762, IC7763, IC7764, IC7765, IC8013, IC8057, IC8058, IC8128, IC8130, IC8131, IC8132, IC8387, IC8401, IC8402, IC8560, IC8621, IC8623, IC8748, IC8750, IC8752, IC8763, IC8814, IC9092…
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.
FDA-determined cause: Under Investigation by firm
Action taken
On August 12, 2026 URGENT MEDICAL DEVICE RECALL (REMOVAL) letters were sent to customers. Actions to be Taken: 1. Hospital inventory can continue to be used while awaiting service from Abiomed to ensure continuity of care. 2. Abiomed s field service team will contact you to schedule the specified replacement. 3. In the event of these purge flag component failures and associated alarms, as per IFU, first reinsert purge disc to address the alarm. If that action does not clear the alarm, switch to a backup Automated Impella Controller. 4. Ensure cleaning of the AIC housing with mild detergent as specified in the IFU. 5. Ensure future routine preventive maintenance is performed annually on your AIC(s) following the guidance in the IFU 6. Forward this notice to anyone in your facility that needs to be informed. 7. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 8. Post a copy of this notice in a visible area for awareness.
Details
- Recall number
- Z-3149-2026
- Initiated
- August 12, 2026
- Posted by FDA
- September 16, 2026
- Product code
- OZD – Temporary Non-Roller Type Left Heart Support Blood Pump
- Quantity
- 1422 units (487 US, 935 OUS)
- Distribution
- Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New…
- Recalling firm
- Abiomed, Inc., Danvers, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3148-2026 | Automated Impella Controller (AIC) with the below product descriptions and corresponding…The potential for purge cassette recognition issues due to the failure of the purge flag component of the… | 08/12/2026Open, Classified |
| Z-3150-2026 | Impella Optical Controller, Automated Impella Controller, Impella Connect Package with…The potential for purge cassette recognition issues due to the failure of the purge flag component of the… | 08/12/2026Open, Classified |