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	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc, or its employees that the report constitutes an admission that the product, abiomed inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the clinic wanted to conduct a training session at the automated impella controller (aic).Upon starting the aic, the system failed to boot and the console recommended switching to a different console.There was no patient involvement.
Additional Manufacturer Narrative
Section d brand name corrected.
Additional Manufacturer Narrative
H8 was erroneously entered on the initial manufacturer device report.The impella device was returned, and an evaluation is underway.Upon completion of our analysis, a supplemental report will be filed.D9 updated.
Additional Manufacturer Narrative
Corrected information has been provided in h3.The root cause of the "system self check failed" screen was not determined due to the inability to reproduce the reported issue.

• 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: 24639584
• Report Number: 1220648-2026-05638
• Device Sequence Number: 21272434
• Product Code: OZD
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,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: 1096906
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 03/20/2026; 04/16/2026; 05/15/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/24/2026; 04/16/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2012
• 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