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	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4 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
It was reported that an automated impella controller entered battery mode despite being permanently connected to the electrical current, then spontaneously returned to receiving electrical power.No patient harm was reported.
Additional Manufacturer Narrative
The impella device was returned, and an evaluation is underway.Upon completion of our analysis, a supplemental report will be filed.Section d9 has been updated.Section d brand name corrected.
Additional Manufacturer Narrative
Added d3 manufacturer fax was omitted during initial report.Updated h3 device evaluated by manufacturer to "yes".H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The root cause of the ¿battery level low¿ alarm was most likely that the aic was disconnected from ac power for an extended period, indicating a user-related issue.No issue within the aic was found.

• 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: 24177102
• Report Number: 1220648-2026-01511
• Device Sequence Number: 9979805
• Product Code: OZD
• UDI-Device Identifier: 00813502011289
• UDI-Public: (01)00813502011289(10)1311372(11)171127
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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 Catalogue Number: 0042-0000-EU
• Device Lot Number: 1311372
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 06/03/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/30/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2017
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White