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	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4.Weight of the patient, a5 ethnicity, and a6.Race 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.
Event or Problem Description
The complainant reported that a physician indicated the impella purge cassette was leaking during support with an impella pump.A follow-up for the issue was performed in the intensive care unit (icu).At the time of follow-up, the icu team was not aware of an active leak, and no leakage was observed.It was noted that the purge cassette docking appeared sticky.No alarms were reported on the system.The icu team was unsure whether the purge cassette had already been replaced.At the time of report writing, the patient remained on support with the impella pump.No signs or symptoms of patient injury or patient harm were reported in association with this event.
Additional Manufacturer Narrative
D4 revised.It was reported the cassette was discarded.
Additional Manufacturer Narrative
B5 and d4 revised this report is for the cassette.A case has been opened to report the adverse events, submission is pending.
Event or Problem Description
An impella cpsa c9+ device was inserted via the right femoral artery in a 72-year-old male patient with cardiomyopathy.The patient¿s comorbidities and clinical state prior to initiation of support were unknown.The physician reported a leaking purge cassette, but icu staff were not aware of the issue and no active leaking was found on follow-up, though sticky purge docking was noted.The purge cassette was not exchanged, and the leakage resolved on its own.The patient remained on support with the same purge cassette and pump, was awake and stable, not requiring catecholamines, and was awaiting a decision for lvad or impella 5.5.No further alarms appeared regarding this issue.Later, the physician reported the patient developed a high tendency to bleed, with suspected acquired von willebrand syndrome under impella cp therapy.After this bleeding tendency, the pump stopped running and could not be restarted, with a failure mode of high motor current.The device was explanted and replaced with a new impella cp.Purge was stable throughout (purge pressure 600 mmhg with stable flow).The patient remained stable and experienced no harm.The patient survived to explant.Bleeding may be associated with underlying critical illness, device-related factors such as acquired von willebrand syndrome, and the anticoagulation and purge requirements associated with impella support.
Event or Problem Description
Per the customer.No leaking found, but sticky purge docking.This impella cassette report is one of two devices associated with the event.Refer to the related manufacturer report number as noted in section h10 for the medical device report on the impella cpsa.
Additional Manufacturer Narrative
B5: added additional information and related device information.H10: added related device report number.

• 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 ; 7814934967
• MDR Report Key: 24903579
• Report Number: 1220648-2026-06888
• Device Sequence Number: 15921282
• Product Code: OZD
• UDI-Device Identifier: 00813502012477
• UDI-Public: (01)(11)251204(17)281031(10)2028841
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup,Followup

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: 2028841
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 05/04/2026; 05/27/2026; 06/30/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/04/2026; 05/08/2026; 06/13/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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 Age: 72 YR
• Patient Sex: Male