MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, MOBILE POWER UNIT, N/A; Ventricular (Assist) Bypass

Model Number	107754
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that replacement was requested due to defective thread on the connection of the mobile power unit (mpu) cable.When connecting the device to the system controller, there was an issue with the screw threads, causing resistance and stiffness when turning the screw.In addition, it was noted that it was difficult to visually identify any differences.No patient consequence was noted.
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• Brand Name: HEARTMATE®, MOBILE POWER UNIT, N/A
• Common Device Name: Ventricular (Assist) Bypass
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 25021507
• Report Number: 2916596-2026-02293
• Device Sequence Number: 18549786
• Product Code: DSQ
• UDI-Device Identifier: 05415067038234
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Device Lot Number: 10844768
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 110 LB