MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 AUTOMATED IMPELLA CONTROLLER; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	AUTOMATED IMPELLA CONTROLLER
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
The complainant reported a patient was implanted with an impella device for mechanical circulatory support.It was reported that the battery had an issue on alarm, and no information about error code.Subsequently they switched the automated impella controller (aic), as follows there is a need of replacement of the device.No patient injury was reported.The patient outcome is stable.
Additional Manufacturer Narrative
D9 updated; the product has been returned.The investigation is still ongoing.
Additional Manufacturer Narrative
Corrections: h6 component code g04035 changed to g0201201 and g07001.The investigation for the communication issue has been completed.The device and logs were returned and evaluated.The communication issue with the power battery manager during boot up was observed and determined to be caused by pbm corrosion, due to leakage of the electrolyte from the battery failure alarm super capacitors.

• Brand Name: AUTOMATED IMPELLA CONTROLLER
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 23961150
• Report Number: 1220648-2026-00145
• Device Sequence Number: 9528573
• Product Code: OZD
• UDI-Device Identifier: 00813502011289
• UDI-Public: (01)00813502011289(10)1319205(11)180116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AUTOMATED IMPELLA CONTROLLER
• Device Catalogue Number: 0042-0000-EU
• Device Lot Number: 1319205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 01/19/2026; 02/23/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/30/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown