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

Model Number	AUTOMATED IMPELLA CONTROLLER
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the automated impella controller had a system self check failure.
Additional Manufacturer Narrative
The automated impella controller was not received from the customer.Therefore, the investigation of the device was not possible.Should the device or any new information be received, a supplemental report will be filed.
Additional Manufacturer Narrative
B.5 additional information was received.G.1 manufacturing site name and address should of been left blank on the initial report that was submitted.
Event or Problem Description
Additional information was received.It is unknown whether a patient case was involved in the discovery of the failure.The controller is scheduled for return.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct a previously reported h6 impact code the impact code f26 reported on the initial mdr was not applicable to the event and has been removed and updated with a correct one.

• Brand Name: AUTOMATED IMPELLA CONTROLLER
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen 52074 ; GM 52074
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24021228
• Report Number: 1220648-2026-00445
• Device Sequence Number: 10594877
• Product Code: OZD
• UDI-Device Identifier: 00813502011289
• UDI-Public: (01)00813502011289(10)1192789(11)150609
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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

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: 1192789
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 02/10/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/12/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2015
• 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