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

Model Number	2465
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery was returned due to corroded contacts.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of corrosion on the 14v battery contacts was confirmed.The returned 14v li-ion battery, serial (b)(6), showed signs of corrosion on the j2 contacts.The battery went through a charge/discharge cycle and placed in a universal battery charger (ubc) for further testing, and no atypical signals were observed.The battery was able to charge to full bars as intended.The 14v battery was hooked up to a mock loop, system controller, and returned battery clip.The battery was functionally tested and found to operate as intended during analysis; no alarms were produced.The corroded contact did not affect functionality of the battery.A root cause for the reported event was not conclusively determined through this analysis.The 14v battery was inspected and accepted into the storage location on 10jun2024.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.Heartmate 3 instructions for use section 3-¿powering the system¿ and heartmate 3 patient handbook section 3-¿powering the system¿ explain how to clean and maintain proper function of the batteries.Heartmate 3 patient handbook 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.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: 23341942
• Report Number: 2916596-2025-06849
• Device Sequence Number: 12714686
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)GY144-B039(17)270523
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: GY144-B039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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: 36 YR
• Patient Sex: Female
• Patient Weight: 93 KG