MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	2000171
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient implanted with an impella cp experienced a leak at the luer-lock connection of the sidearm, and a leak was in the tubing of the purge cassette.As the patient was already undergoing weaning and impella explant was planned, no new purge cassette was connected or tested.The existing support was continued until the planned explant.No patient harm was reported.
Additional Manufacturer Narrative
A2, a4, a5, and a6 are 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.

• 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): Abiomed Europe GmbH; neuenhofer weg 3; aachen ; GM
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50896612
• Report Number: 1220648-2026-13350
• Device Sequence Number: 10705683
• Product Code: OZD
• UDI-Device Identifier: 00813502012477
• UDI-Public: (01)00813502012477(17)290331(10)2083631
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: 2000171
• Device Lot Number: Lot 2083631
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2026
• 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: Male