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

Model Number	IMPELLA CONTROLLER, PACKAGED, US
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
During impella cp support, the patient experienced a wrong placement signal.Clinician stated that the placement signal of the optical sensor was 20/20 mmhg wich was different from patients actual blood pressure upon implant and for duration of case.There were no consequences noted for the patient and the case.This is considered a reportable malfunction.
Additional Manufacturer Narrative
The events of this report have been reported in mrn 1220648-2026-04616.

• 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: 24462337
• Report Number: 1220648-2026-04164
• Device Sequence Number: 18485843
• Product Code: OZD
• UDI-Device Identifier: 00813502011289
• UDI-Public: (01)00813502011289(10)1109485(11)120629
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: IMPELLA CONTROLLER, PACKAGED, US
• Device Catalogue Number: 0042-0000-US
• Device Lot Number: 1109485
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2012
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White