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

Catalog Number	0042-0000-EU
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Hemodynamic instability (4868)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.Patient information is unknown.Device status.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
Clinical rationale: an impella cp device was inserted via the right femoral artery in a 64-year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs).During support, the automated impella controller (aic) required replacement.The reported events are controller failure, device revision or replacement, medical device removal, and hemodynamic instability.Although the case is coded as product malfunction, the impella cp is being conservatively reported for serious injury due to a temporary interruption of hemodynamic support during the console exchange; however, the exchange was performed with no consequence to the patient, and hemodynamic support was resumed.
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.
Additional Manufacturer Narrative
Additional information has been provided in d9.Corrected information has been provided in h3.The root cause of the controller failure alarm was a communication problem between the main computer and the pump motor driver.
Additional Manufacturer Narrative
Section h6: the clinical code and impact codes were updated to the correct ones which was inadvertently reported incorrect in the previous report.

• Brand Name: IMPELLA CONTROLLER, PACKAGED, EU
• 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: 24245536
• Report Number: 1220648-2026-02134
• Device Sequence Number: 9657403
• Product Code: OZD
• UDI-Device Identifier: 00813502011289
• UDI-Public: (01)00813502011289(10)1121932(11)121219
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0042-0000-EU
• Device Lot Number: 1121932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 04/16/2026; 04/17/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/24/2026; 04/17/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown