MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET; Ventricular (assist) bypass

Model Number	2465
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that abbott received a system controller, 14v batteries, 14v battery clips, and a mobile power unit (mpu) cord for an unknown reason.It was said the patient associated with these devices passed away on (b)(6) 2025.It was unclear why the devices were sent back at this time.The cause of death was said to be due to sepsis.The patient death was not considered to be device related.The device operated as expected.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the 14-volt battery, lot number gx220358, was evaluated following a return for an unknown reason.The 14v battery was able to pass all functional testing.The battery went through a charge/discharge cycle and was inserted into a test universal battery charger and was accepted for charge.The battery was functionally tested with the returned system controller, returned 14v battery clip, and mock circulatory loop and was found to support the system as intended during analysis.Provided information indicated that the patient associated with these devices passed away on (b)(6) 2025.It was reported that the reason for the return was unknown.The provided cause of death was said to be due to sepsis.The patient death was not considered to be device related.Incidental findings: the 14v li-ion battery, serial (b)(6), was returned for analysis with corrosion on the j2 component.A dhr review is not required per procedure and was not performed.The heartmate 3 left ventricular assist device (lvas) instructions for use (ifu), rev.B and the heartmate 3 patient handbook, rev.A are currently available.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Section 7 of the ifu and section 5 of the patient handbook entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms.Heartmate 3 instructions for use section 3 ¿ ¿powering the system¿ and heartmate 3 patient handbook section 3 ¿ ¿powering the system¿ addresses how to properly use the 14v battery clip.Heartmate 3 patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment, including the 14v battery clip.Additionally, section 10 entitled ¿safety checklists¿ instructs users to regularly inspect their accessories ¿ including their battery clips ¿ for damage, and to replace any equipment that appears damaged or worn.The heartmate 3 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET
• 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: 24332700
• Report Number: 2916596-2026-00952
• Device Sequence Number: 15898063
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)GX220-B088(11)230808
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

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 Expiration Date: 08/08/2026
• Device Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: GX220-B088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• 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: 02/11/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 107 KG