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

Catalog Number	0042-0000-EU
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The console was returned to field service for annual preventive maintenance.Upon initial startup, a red battery failure alarm was displayed.
Additional Manufacturer Narrative
The impella device was returned, and an evaluation is underway.Upon completion of our analysis, a supplemental report will be filed.
Additional Manufacturer Narrative
The impella device was returned, and an evaluation is underway.Upon completion of our analysis, a supplemental report will be filed.D9 updated.E4 was inadvertently omitted on the initial manufacturer device report.
Additional Manufacturer Narrative
Corrected information was provided in d3 (manufacturer fax).Upon review, it was identified that it was inadvertently omitted from the initial report.Corrected information was provided in h3 (device evaluated by manufacturer?).Upon review, the section h device evaluated by manufacturer? has now been updated.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The root cause of the battery failure alarm on ic7406 was an internal battery fault likely due to the customer not routinely charging the console.

• 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 (Section G): DANVERS
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24741052
• Report Number: 1220648-2026-06154
• Device Sequence Number: 18351382
• Product Code: OZD
• UDI-Device Identifier: 00813502011289
• UDI-Public: (01)00813502011289(10)1424423
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,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 Catalogue Number: 0042-0000-EU
• Device Lot Number: 1424423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 04/28/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/14/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2019
• 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