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

Catalog Number	0048-0045
Medical Device Problem Codes	Restricted Flow rate (1248); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned d9 was updated.
Additional Manufacturer Narrative
Correction: this report is being submitted to correct h9.Upon further review, it was determined that the report was incorrectly associated with a recall.This information was entered in error, and with current information the event is not associated with any recall.
Additional Manufacturer Narrative
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
An impella cp device was inserted into the right femoral artery in a 70-year-old male patient presenting in acute myocardial infarction (ami) and cardiogenic shock (cgs), in scai stage d shock, on multiple inotropes and vasopressors, and on a ventilator for respiratory support, prior to initiation of support.The impella was inserted for ventricular support for a protected percutaneous coronary intervention (pci).While the patient was in the intensive care unit (icu), hemolysis was noted by red/pink urine and hemolyzed labs.Plasma free hemoglobin was 200.The hemoglobin and hematocrit (h/h) were stable at 13.2 and 39.6.Position verified as suboptimal, but unable to correct.Later in the day, there was ongoing suction.Flow dropped down to p-2, but suction continued.Plan to escalate to 5.5.Suction alarms disabled.After 15 hours of support, the device was removed with an escalation of therapy to an impella 5.5.The impella functioned at p-5 at 3.5l/min as intended.Hemolysis may be influenced by patient-specific factors such as critical illness, underlying cardiac dysfunction, hemodynamic instability, and potential device position.
Additional Manufacturer Narrative
Additional information has been provided in d3.Corrected information has been provided in h3.Hemolysis/pdi: the cause of the injury was not determined due to insufficient clinical details.Device in wrong position: the cause of the device in wrong position could not be determined as limited clinical details were provided.Low or blocked pump flow: the cause of the low pump flow could not be definitively determined as no data logs were returned and issue did not reproduce with returned product.

• 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: 25136913
• Report Number: 1220648-2026-07727
• Device Sequence Number: 18520652
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)270930(10)2026762907
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2026762907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 05/12/2026; 05/13/2026; 07/02/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/12/2026; 05/15/2026; 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 95129
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White