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

Catalog Number	0048-0024-JP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemolysis (1886); Renal Failure (2041)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2.Patient age at the time of event is unknown.A3a.Sex/a3b.Gender is unknown.A4.Weight of the patient is unknown.A5 ethnicity is unknown.A6.Race 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
Clinical rationale: a patient with unknown demographics and gender, treated for acute myocardial infarction and cardiogenic shock (pre support scai stage c), was supported with an impella cp inserted via the right femoral artery on (b)(6) 2026.Hemolysis was identified during cp support, diagnosed by hematuria.Imaging confirmed correct impella cp positioning, and pump volume was reported as adequate.Despite this, hemolysis persisted and continuous dialysis was required for several days, though urine output was maintained.The impella cp was not removed due to a device failure mode, and no anatomic abnormalities, organ damage, or valve contact were reported.On (b)(6) 2026, the patient was escalated to impella 5.5 support due to insufficient hemodynamic support from the cp and anticipated prolonged therapy.Hemolysis onset timing is unknown, and the relationship between the device and patient outcome is listed as unknown.The patient survived the cp explant on (b)(6) 2026, and the impella 5.5 remains in place.The cp pump is expected to be returned for evaluation; data download is required.Available information confirms that hemolysis occurred while the impella cp was in correct position and functioning within reported parameters.No device related mechanical interaction with cardiac structures was identified.The event may be associated with the patient¿s underlying condition and need for escalating mechanical circulatory support, but a definitive causal relationship cannot be established based on the current data.
Additional Manufacturer Narrative
Corrected information has been provided in d1 brand name.Added d3 manufacturer fax was omitted during initial report.Corrected d4 serial number.H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The cause of the issue was not determined without returned product investigation and sufficient clinical details.The cause of the injury was not determined due to insufficient clinical details.

• 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 (Section G): DANVERS
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24650272
• Report Number: 1220648-2026-05722
• Device Sequence Number: 10008710
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(17)270731(10)2026743237
• 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: 2026
• Device Explanted Year: 2026
• 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

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: 0048-0024-JP
• Device Lot Number: 2026743237
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown