Thoratec® HeartMate 3™ VAD Modular Cable 106525USRecalls & reported problems

Summary

The FDA's MAUDE database contains 844 adverse event reports that list this exact device (DI 00813024013181), received between Jul 27, 2018 and Sep 30, 2026 — classified as 57 injuries, 787 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (368 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 844 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953124 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951616 ↗
• MalfunctionSep 30, 2026Corroded; Electrical /Electronic Property Problem

  It was reported that patient had a Driveline Communication Fault. Log File review found Driveline Comm Fault B Alarms on (b)(6) 2026. Motor function was not affected by these events. It was recommended that the System Controller and Modular Cable be replaced. The Modular Cable was examined during the exchange, pictures of the Pump/Modular Cable Connecter showed some corrosion. The site proceeded with the Modular Cable exchange. The patient was stable throughout. The patient also had a small tear in the proximal cable, with no exposed wires or Kevlar. Patient also with exposed velour.It was reported that the alarm did not resolve following Modular Cable exchange and that the Controller was now displaying Driveline Power Fault on the Monitor, not Driveline Communication Fault. Pump parameters within baseline. The Event Log File recorded on 25Jun2026, Driveline Power Fault A alarms. Motor function was not affected by this event. The alarm were disabled on the Monitor given the known fault. The connector would need to be cleaned. Technical Services would be onsite on (b)(6) 2026 for Pump end Connector cleaning for ongoing Driveline Power/Comm Faults. During the cleaning procedure the M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948654 ↗
• MalfunctionSep 30, 2026Contamination /Decontamination Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947187 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935631 ↗
• MalfunctionSep 25, 2026Communication or Transmission Problem

  It was reported that the patient had a Driveline Communication Fault Alarm and presented to the clinic for evaluation. The Modular Cable was exchanged, which the patient tolerated without issue. Log Files were obtained before the exchange. The Log File captured Driveline Communication Fault alarms beginning at 5:55 AM the morning of (b)(6) 2026. The system continued to operate at the set speed and was supported by the Controller¿s Backup Battery until external power was restored. There were no other unusual events recorded in the Log File Event History. The Mechanical Circulatory Support (MCS) equipment was operating as intended. The alarm resolved after the Modular Cable was exchanged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899553 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  It was reported that the patient had Driveline Power Fault. The Log Files were submitted for review and the Modular Cable was exchanged. The alarm resolved after System Controller was exchanged. There was no evident erosion at the Modular Cable site. The Event Log File review showed dates from (b)(6) 2026. The Event Log File captured Driveline Power Faults (Power B) starting from the beginning of the data and continued for the remainder of the Log File. The picture provided showed the inline connector to be clean with no notable debris or corrosion.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896745 ↗
• MalfunctionSep 24, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886339 ↗
• MalfunctionSep 2, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571785 ↗
• MalfunctionAug 26, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457050 ↗
• MalfunctionAug 19, 2026Electrical /Electronic Property Problem; Mechanical Problem; Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331112 ↗
• MalfunctionAug 17, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286684 ↗
• MalfunctionAug 17, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279926 ↗
• MalfunctionFeb 26, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DRIVELINE POWER FAULT ALARM. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED DRIVELINE POWER FAULT A ALARMS ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455756 ↗
• MalfunctionFeb 6, 2026Mechanical Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT ON 01JAN2026 THE PATIENT BEGAN EXPERIENCING DRIVELINE COMMUNICATION FAULTS. THE ALARM DID NOT CLEAR WITH SELF-TESTS. THE PATIENT'S CONNECTIONS WERE CHECKED, AND NO ISSUES WERE FOUND. THE ALARM WAS CLEARED TO SEE IF IT WOULD RECUR. LOG FILE REVIEW WAS REQUESTED, WHICH REVEALED COMMUNICATION FAULTS STARTING ON 01JAN2026 AND CONTINUING FOR THE REST OF THE LOG FILE ASSOCIATED WITH A SINGLE COMM_A FAULT. PER THE SITE, THE PATIENT'S DRIVELINE LOOKED GOOD AND THERE WAS NO OBVIOUS TRAUMA. SINCE THE COMMUNICATION FAULTS HAD NOT YET RECURRED, NO EQUIPMENT WAS EXCHANGED, HOWEVER THE SITE NOTED THEY WOULD EXCHANGE THE SYSTEM CONTROLLER AND MODULAR CABLE IF ALARMS RECURRED. ON 05JAN2026, ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT'S MODULAR CABLE WAS TAPED IN 2 SPOTS DUE A SMALL HOLE IN THE OUTER LAYER. ON 06JAN2026, IT WAS REPORTED THAT THE DRIVELINE COMMUNICATION FAULTS RETURNED AFTER BEING CLEARED ON 02JAN2026. THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED, WHICH RESOLVED THE ALARMS. LOG FILE REVIEW WAS REQUESTED, WHICH REVEALED DRIVELINE COMMUNICATION FAULTS ON 02JAN2026, 03JAN2026, AND 04JAN2026. NO OTHER UNUSUAL EVENTS WERE NOTED. NO CORROSION TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279590 ↗
• MalfunctionFeb 4, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PATIENT HAD DRIVELINE FAULTS ALARMS. LOG FILES CAPTURED DRIVELINE POWER FAULT EVENTS FROM 11JAN2026 AT 1459 AND CONTINUED FOR THE REST OF THE LOG FILE. LOG FILES WERE ATTACHED FOR REVIEW AND CONFIRMED DRIVELINE POWER B FAULTS ALARMS ON (B)(6) 2026 IT WAS SUGGESTED TO EXCHANGE THE MODULAR CABLE AND SYSTEM CONTROLLER TO ATTEMPT TO RESOLVE THE ALARMS. THIS ALARM HAD NOT INTERFERED WITH PUMP OPERATION. THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED WHICH RESOLVED THE DRIVELINE POWER FAULTS. NO DEBRIS OR CORROSION WAS NOTED INSIDE THE MODULAR CABLE OR PRIMARY DRIVELINES WHEN DISCONNECTED. THE MODULAR CABLE THE PATIENT HAD NO DAMAGE OR TEARING AND THE CONTROLLER HAD NO VISIBLE DAMAGE. THE PATIENT WAS ACTIVELY LISTED FOR TRANSPLANT. THE PATIENT HAD THE SAME SYSTEM CONTROLLERS SINCE IMPLANT. LOG FILE FROM SYSTEM CONTROLLER, (B)(6), SHOWED THE PATIENT WAS CONNECTED TO THIS SYSTEM CONTROLLER ON (B)(6) 2026 AT 14:04:19. THE DATA COLLECTED AFTER THE PATIENT WAS PLACED ON THIS CONTROLLER SHOWED THE DRIVELINE POWER FAULT ALARM DID NOT RETURN. IT WAS RECOMMENDED TO REPLACE THE BACKUP CONTROLLER, (B)(6). THE NEW SYSTEM CONTROLLER WAS DISPENSED AS THE PATIENT'S NEW BACK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261622 ↗
• MalfunctionFeb 3, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT PATIENT ARRIVED TO CLINIC ON (B)(6) 2024 WITH NOTED TELESCOPING TO MODULAR CABLE AND DAMAGE TO DRIVELINE. RESCUE TAPE WAS APPLIED TO DRIVELINE. IT WAS ATTEMPTED TO CONNECT THE NEW MODULAR CABLE TO THE SECONDARY SYSTEM CONTROLLER WITHOUT SUCCESS OF INSERTION OF CONNECTOR INTO THE CONTROLLER. THE CONTROLLER WAS ALSO REPLACED ALONG WITH MODULAR CABLE. IT WAS INDICATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254412 ↗
• MalfunctionFeb 3, 2026Mechanical Problem

  IT WAS REPORTED THAT PATIENT ARRIVED TO CLINIC ON (B)(6) 2024 WITH NOTED TELESCOPING TO MODULAR CABLE AND DAMAGE TO DRIVELINE. RESCUE TAPE WAS APPLIED TO DRIVELINE. IT WAS ATTEMPTED TO CONNECT THE NEW MODULAR CABLE TO THE SECONDARY SYSTEM CONTROLLER WITHOUT SUCCESS OF INSERTION OF CONNECTOR INTO THE CONTROLLER. THE CONTROLLER WAS ALSO REPLACED ALONG WITH MODULAR CABLE. IT WAS INDICATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254405 ↗
• MalfunctionJan 29, 2026Mechanical Problem; Communication or Transmission Problem; Material Twisted/Bent

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR THE PATIENT ALONG WITH X-RAYS. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM (ER) AFTER THEIR SYSTEM CONTROLLER ALARMED FOR DRIVELINE COMMUNICATION FAULT AND WAS ASYMPTOMATIC PRIOR TO AND AFTER ARRIVAL. IT WAS NOTED THERE WAS A LOT OF RESCUE TAPE ON THE PROXIMAL EXTERNAL PART OF THE DRIVELINE, AND SOME TWISTING WITH A SMALL DEFECT IN THE MODULAR CABLE SECTION. THE LOG FILES CAPTURED DRIVELINE COMMUNICATION A FAULT ALARMS ON (B)(6) 2025. IT WAS RECOMMENDED TO EXCHANGE THE MODULAR CABLE AND SYSTEM CONTROLLER AND TO PERFORM 15 POWER CABLE DISCONNECT ALARMS SO THAT NEW LOG FILE DATA CAN BE RECORDED AND REVIEWED. THE REPORTED ALARM DID NOT INTERFERE WITH PUMP OPERATION, AND THE X-RAY IMAGES WERE UNREMARKABLE. ADDITIONAL LOG FILES WERE SUBMITTED AFTER CONTROLLER AND MODULAR CABLE WERE EXCHANGED AS SUGGESTED WHICH SHOWED THE ALARM DID NOT RECUR. THE SUBMITTED PHOTO OF THE CONNECTOR ALSO LOOKED GOOD WITH NO ADDITIONAL ACTION NEEDED IN RESPONSE. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211150 ↗
• MalfunctionJan 27, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S MODULAR CABLE WAS TAPED AND REPAIRED IN SEVERAL PLACES AND WAS NO LONGER CONSIDERED SAFE TO USE BY THE HEALTH CARE PROFESSIONAL. THE MODULAR CABLE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191282 ↗
• MalfunctionJan 27, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXTENSIVE DRIVELINE DAMAGE DUE TO TRAUMA FROM A DOG CHEWING ON IT. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO WAS SUBTHERAPEUTIC AT THE TIME OF DISCOVERY AND IT WAS SAID THE MODULAR CABLE WOULD BE EXCHANGED OUT LATER IN THE WEEK. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED NO EVIDENCE OF ANY TYPE OF DRIVELINE ELECTRICAL CONDUCTOR ISSUE IN THE LOG FILE. THE LOG FILES CONTAINED PULSATILITY INDEX EVENTS AS WELL AS ROUTINE POWER SOURCE CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191120 ↗
• MalfunctionJan 22, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE COMMUNICATION FAULT ALARM TWICE IN (B)(6) 2025 WHICH REQUIRED A SYSTEM CONTROLLER AND MODULAR CABLE EXCHANGE. THE ALARM REOCCURRED ON (B)(6) 2025. LOG FILES WERE SENT FOR REVIEW. THE EVENT LOG FILE RECORDED A DRIVELINE COMM FAULT AT ON (B)(6) 2025 AT 08:54:59. MOTOR FUNCTION WAS NOT AFFECTED BY THIS EVENT. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED AGAIN. THE ALARMS RESOLVED AFTER THE EXCHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152439 ↗
• MalfunctionJan 21, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE POWER FAULT ALARM. THE PATIENT FELT FINE AND THE PUMP PARAMETERS WERE NORMAL. THERE WERE NO OTHER ALARMS. THE PATIENT PERFORMED A SELF-TEST AND THE DRIVELINE POWER FAULT ALARM WAS REPLACED BY A BACKUP BATTERY (EBB) ALARM. LOG FILES WERE SUBMITTED FOR REVIEW AND CONFIRMED DRIVELINE POWER FAULTS AS REPORTED STARTING AT 1429 ON 10JAN2026 AND CONTINUED FOR THE REMAINDER OF THE LOG. THE EBB FAULTS STARTED IN CONJUNCTION WITH THE DRIVELINE POWER FAULTS AT 1517 ON 10JAN2026 AFTER THE SYSTEM CONTROLLER SELF-TEST. THE ALARM CLEARED WITH A NEW MODULAR CABLE AND SYSTEM CONTROLLER. ADDITIONAL LOG FILES WERE SUBMITTED FOR REVIEW, AND IT APPEARED THAT THE DRIVELINE POWER FAULTS AND EBB FAULTS RESOLVED AFTER THE EQUIPMENT EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24139882 ↗
• MalfunctionJan 12, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS A SEVERE KINK IN THE MODULAR CABLE. THE MODULAR CABLE WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24042052 ↗
• MalfunctionJan 9, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE CLINIC TO DOWNLOAD LOG FILES AND PERFORM A MODULAR CABLE REPLACEMENT DUE TO A DRIVELINE POWER FAULT. THE HEALTHCARE PROVIDER DID NOT ATTEMPT TO CLEAR THE ALARM, THE LAST TRY TO CLEAR THE ALARM WAS IN (B)(6) 2025 WHICH INITIALLY SILENCED THE EVENT, BUT IT REOCCURRED IN THREE HOURS THAT THEN PROMPTED THE IN-PERSON ABBOTT ENGINEER TEAM TO CLEAN THE MODULAR CABLE CONNECTION WHICH THEN CLEARED THE ALARM UNTIL THE DATE OF THIS EVENT. THE HEALTHCARE PROVIDER THEN PERMANENTLY SILENCED THE ALARM. THERE WAS NO OBVIOUS EXTERNAL DAMAGE TO THE DRIVELINE OF THE MODULAR CABLE INTERFACE, AND THE PATIENT WAS HEMODYNAMICALLY STABLE. THE LOG FILE CAPTURED NEW DRIVELINE POWER FAULT ALARMS BEGINNING ON (B)(6) 2025. THE PLAN WAS TO HAVE THE PATIENT TRANSFERRED TO ANOTHER HOSPITAL TO CLEAR THE ALARMS AND REPLACE THE MODULAR CABLE. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. ADDITIONAL LOG FILES WERE SUBMITTED THAT SHOWED ON (B)(6) 2025, MULTIPLE DRIVELINE POWER FAULTS (PWR B). THE MODULAR CABLE AND CONTROLLER HAD BEEN REPLACED TO TRY AND RESOLVE THE ISSUE, AND A REPLACEMENT WAS REQUESTED. IT WAS ADDITIONALLY COMMUNICATED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028862 ↗