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

Catalog Number	0043-0002
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4 is unknown.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 an automated impella controller failed to recognize a purge cassette.No patient harm was reported.
Additional Manufacturer Narrative
Section d medical device has been updated.
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.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The current (b)(4) is open to address the failure to detect purge cassette issue involving the first purge cassette, s/n (b)(6), lot 1776090.Data log review was not sufficient to derive the cause of the purge cassette not detected issue.The cause of the failure to detect purge cassette issue could not be determined without the returned product for investigation and sufficient clinical details.

• Brand Name: UNK_PURGE CASSETTE
• 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: 24557110
• Report Number: 1220648-2026-04865
• Device Sequence Number: 8860012
• Product Code: OZD
• UDI-Device Identifier: 00813502010510
• UDI-Public: (01)00813502010510(17)261031(10)1813686
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 0043-0002
• Device Lot Number: 1813686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 05/12/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/24/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White