MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY; Ventricular (Assist) Bypass

Model Number	106128
Medical Device Problem Codes	Electrical Power Problem (2925); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a backup battery with a yellow wrench occurred right after the exchange.New backup battery was ordered.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• Brand Name: THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY
• 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 ; +1(781)852-8207
• MDR Report Key: 24508767
• Report Number: 2916596-2026-00996
• Device Sequence Number: 21322164
• Product Code: DSQ
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 11137141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2026
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q325-HF-4
• Patient Sequence Number: 1
• Patient Sex: Unknown