MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number	106762
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient was experiencing backup battery faults frequently over the past year and more.Initially, it was to have cleared with the completion of a self-test, but since summer of 2025, the patient had needed a new 11v battery, which were issued outside of the 36-month rotation and was said to have received replacements in (b)(6) 2025 and again in (b)(6) 2025 (b)(6).The backup battery fault recurred in (b)(6) 2026 and initially resolved when the patient plugged into the power module (pm), despite education to remain on battery power.It was said to have recurred again and has been persistent for the past week and more.The prior alarm resolved on (b)(6) 2026.The patient has had a known internal driveline fracture and had a driveline repair up to velour in the past.The patient has also been issued a new pocket controller in (b)(6) 2023 (b)4).The emergency backup battery (ebb) faults were said to no be related to the driveline.It was recommended to replace the system controller.
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed via the provided log file.The log file captured backup battery fault alarms on (b)(6) 2026 per timestamps.These alarms correlated to load test conditions and did not prevent the pump from operating as intended throughout the data.The system controller (serial number unknown) was not returned for analysis.Questions regarding the event were asked multiple times and no responses were received.The root cause of the backup battery fault alarm was unable to be conclusively determined through this analysis, and a corrective action was initiated in order to further investigate the issue.The serial number of the system controller was not provided.The heartmate ii lvas instructions for use (section 7 ¿alarms and troubleshooting¿) and the heartmate ii patient handbook (section 5 ¿alarms and troubleshooting¿) instructs users on how to resolve alarms that sound from their system controller, including alarms associated with backup battery fault conditions.Heartmate ii patient handbook cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER
• 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: 24254449
• Report Number: 2916596-2026-00523
• Device Sequence Number: 21324821
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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: 106762
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: No
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 02/10/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/11/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 142 KG