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

Catalog Number	0042-0000-EU
Medical Device Problem Codes	Failure to Read Input Signal (1581); Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
The complainant reported that the purge cassette was inserted but not recognised.The automated impella controller (aic) displayed the following alarm: purge fluid not recognized.Neither the cassette nor the purge line were flushed.The purge cassette was then replaced and the procedure could continue.The pump could then be flushed and implanted without any problems.The patient suffered no harm.The customer said that this problem has occurred several times on this aic.Therefore, is sending the aic in for inspection.
Additional Manufacturer Narrative
Correction: d6a and d6b should have been left blank on the initial manufacturer device report.The impella device was returned, and an evaluation is underway.Upon completion of our analysis, a supplemental report will be filed.
Additional Manufacturer Narrative
H6, medical device problem code: a1414, priming problem, has been added.
Additional Manufacturer Narrative
D9.Is device returned to manufacturer? and date device returned to manufacturer added.H6: investigation: type, findings, conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The device was not returned; therefore, an evaluation/analysis of the device was not possible.The cause of the purge cassette and purge fluid detection issues on (b)(6) could not be determined due to the inability to reproduce.

• 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: 24218366
• Report Number: 1220648-2026-01891
• Device Sequence Number: 9366321
• Product Code: OZD
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0042-0000-EU
• Device Lot Number: 1174888
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 02/03/2026; 01/26/2026; 06/25/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/04/2026; 04/29/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 198 LB