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

Model Number	IMPELLA CP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemolysis (1886); Unspecified Infection (1930); Renal Failure (2041); Hypovolemia (2243)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The complainant reported a patient was implanted with an impella device for mechanical circulatory support.While on support, the patient was presented with hemolysis.The hemolysis had progressed with haptoglobin administration; however, did not improve and became anuria.Dialysis was started.It was reported that the cause was insufficient circulating blood volume due to infection.No further information was provided.The patient remained on support.
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.
Additional Manufacturer Narrative
B2 revised selection as it was entered incorrectly on the initial report that was submitted.B3 revised date of event.B5 added information that was omitted from the initial report that was submitted.H6 type of investigation was revised due to device discarded.H11 updated due to the device being discarded.The impella device was discarded by the customer and therefore,¿an evaluation of the device was not possible.Should any new information be received, a supplemental report will be filed.
Additional Manufacturer Narrative
H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The device was not returned; therefore, an evaluation/analysis of the device was not possible.The cause of the injuries was not determined due to insufficient clinical details.

• Brand Name: IMPELLA CP
• 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): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen ; GM
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24124323
• Report Number: 1220648-2026-01183
• Device Sequence Number: 6075544
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(10)2026769777(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2026769777
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 02/10/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/22/2026; 02/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian