MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET; VENTRICULAR (ASSIST) BYPASS

Model Number	2465
Medical Device Problem Codes	Corroded (1131); Disconnection (1171); Fire (1245)
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 information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the customer stated they received a call from a patient who noted burn marks on a few of the contacts on one for their 14v batteries.No power related alarms were noted.
Event or Problem Description
In regard to the burn marks, the patient didn't know how it happened.They noticed it only when they put that battery on and the system controller beeped connect to power.The battery wasn't exchanged yet, and the patient wasn't using the battery.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of marks on the contacts of a 14 volt battery was confirmed via submitted photos; however, the reported event of a connect to power alarm was unable to be confirmed.A customer submitted photo revealed black residue, consistent with corrosion, on several 14v battery contact terminals.The heartmate 14 volt lithium-ion battery (serial number (b)(6)) was not returned for analysis; however, it was stated that the patient will be at the hospital in may for a follow up and can bring the battery.If the product is received at a later date, the investigation will be reopened.Provided information stated that the patient did not know how the marks occurred.The issue was observed once the battery was put into use and the system controller alarmed ¿connect to power¿.It was stated that the marks look like either burn marks or corrosion.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause for the reported event was unable to be conclusively determined through this analysis.The testing records were reviewed for the heartmate 14v battery (s/n: (b)(6)) and it was found that the battery operated as intended.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 instructions for use (rev.D) section 3-¿powering the system¿ and heartmate 3 patient handbook (rev.A) section 3-¿powering the system¿ explain how to clean and maintain proper function of the batteries.Heartmate 3 patient handbook (rev.A) section 4-¿living with the heartmate 3¿ states that ¿the heartmate 3 system components must be kept dry.Never expose the system controller, batteries, mobile power unit or power base unit to water.If these system components get wet, your pump may stop.Never take tub baths or go swimming while implanted with the pump.The heartmate® gogear® shower bag must be used while showering to keep the system controller and batteries dry.¿ the ifu states under the weekly safety checklist to clean the metal battery terminals and contacts inside the battery clips and to check for damage.The patient handbook cautions the 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: 24183027
• Report Number: 2916596-2026-00557
• Device Sequence Number: 9557576
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)GZ111-B057(11)250421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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: 2465
• Device Catalogue Number: 2465
• Device Lot Number: GZ111-B057
• 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: 01/27/2026; 02/26/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/13/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian