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

Model Number	AUTOMATED IMPELLA CONTROLLER
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 is unknown.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 automated impella controller showed "failure system, please switch to back up controller".There was no patient involved.
Additional Manufacturer Narrative
Additional information has been provided in d9 including device available for evaluation, device returned to manufacturer and date device returned to manufacturer.Corrected information has been provided in h3 to reflect the device was evaluated manufacturer.H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The cause of the report controller failure was due to a power management circuit board component failure.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 23889571
• Report Number: 1220648-2025-49345
• Device Sequence Number: 11938788
• Product Code: OZD
• UDI-Device Identifier: 00813502011289
• UDI-Public: (01)00813502011289(10)1133144(11)130611
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

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: 1133144
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2013
• 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