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

Model Number	IMPELLA CP SMART ASSIST SET, JP
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported a patient on an impella cp for pre-op placement for mitral valve surgery.When the pump was clamped with a soft jaw clamp to block the aorta, the alarm "pump stop current consumption increase" occurred, and the alarm went off even when the pump was turned to surgical mode.The operation was carried out to the end, and when the impeller was bled before the heart-lung machine was left, the pump would not restart, and the cp was removed at the same time as the heart-lung machine was left.The patient transition to the heart-lung machine and the intra-aortic balloon pump.The patient survived the procedure.
Additional Manufacturer Narrative
The impella device has not been received from the customer.Therefore, investigation of the device is not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Additional Manufacturer Narrative
E4 was inadvertently omitted on the initial manufacturer device report.
Additional Manufacturer Narrative
Pump stop: the cause of the pump stop was an unintended user related issue where the impella was clamped by a soft jaw clamp resulting in pump stop due to clinical details and data log review confirming pump stop following surgical mode use.The returned product showed no physical abnormalities and was able to run without issue.Correction has been updated in d1 and d9.Additional information has been provided in h6 (component code, investigation findings, type of investigation, and investigation conclusions).

• 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 drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24192382
• Report Number: 1220648-2026-01622
• Device Sequence Number: 18110080
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(10)2026696276(17)270430
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMPELLA CP SMART ASSIST SET, JP
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2026696276
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/03/2026; 04/10/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/05/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian