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

Model Number	IMPELLA CP
Medical Device Problem Codes	Break (1069); Restricted Flow rate (1248); Malposition of Device (2616)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The complainant reported a patient on impella support with a cp pump.The complainant reported that an impella in aorta alarm sounded when the patient coughed.The pump was reinserted under fluoroscopy, but the pump did not recover.A thrombus had formed.The impella was surgically removed.
Additional Manufacturer Narrative
The impella device has not been received from the customer, therefore, investigation of the device has not been possible.Should the device or any new information be received, a supplemental mdr will be filed.
Additional Manufacturer Narrative
D6b was erroneously entered on the initial manufacturer device report.E4 was inadvertently omitted on the initial manufacturer device report.
Additional Manufacturer Narrative
H6: added codes a150202 and a140508 based on review by the investigation team.Omitted code a0401.
Additional Manufacturer Narrative
Thrombosis: the cause of the injury was not determined due to insufficient clinical details.Device in wrong position: the cause of the position issue was most likely related to an unintentional use issue, as it occurred while the patient was coughing.Low or blocked pump flow: the cause of the issue could not be determined without the returned product for investigation and sufficient clinical details, including data log.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24131935
• Report Number: 1220648-2026-01237
• Device Sequence Number: 12145419
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(10)2026778580(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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/21/2026

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 Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2026778580
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 01/19/2026; 03/04/2026; 04/09/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 01/22/2026; 03/06/2026; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2025
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian