HeartMate™ 107754Recalls & reported problems

Summary

The FDA's MAUDE database contains 447 adverse event reports that list this exact device (DI 05415067038234), received between Jun 13, 2023 and Sep 30, 2026 — classified as 2 injuries, 445 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (198 reports).

2 FDA recall records name this device's identifier, 2 still open.

30 other recalls cover devices cleared under the same FDA submission (P060040, P160054); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 23, 2025Open, Classified

   Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.

   Z-2291-2025 · Root cause: Vendor change control · FDA record ↗

2. Mar 13, 2025Open, Classified

   Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.

   Z-1570-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 447 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  It was reported that the Mobile Power Unit (MPU) patient cord fell into water, and the clinic advised the device should not be used. A warranty replacement was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948278 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902002 ↗
• MalfunctionSep 2, 2026Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572531 ↗
• MalfunctionJul 27, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000808 ↗
• MalfunctionJun 11, 2026Failure to Power Up

  IT WAS REPORTED THAT THE MOBILE POWER UNIT (MPU) STOPPED WORKING AND WAS NOT TURNING ON AT ALL. THE MPU WOULD BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477671 ↗
• MalfunctionMay 10, 2026Use of Device Problem

  IT WAS REPORTED THAT THE MOBILE POWER UNIT (MPU) WAS CONSTANTLY, CONTENTLY, AND AUDIBLY ALARMING. THE BATTERIES WERE REPLACED, BUT THE ALARMS PERSISTED. THE MPU WAS REPLACED AND INTENDED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133439 ↗
• MalfunctionApr 28, 2026Mechanical Problem

  IT WAS REPORTED THAT REPLACEMENT WAS REQUESTED DUE TO DEFECTIVE THREAD ON THE CONNECTION OF THE MOBILE POWER UNIT (MPU) CABLE. WHEN CONNECTING THE DEVICE TO THE SYSTEM CONTROLLER, THERE WAS AN ISSUE WITH THE SCREW THREADS, CAUSING RESISTANCE AND STIFFNESS WHEN TURNING THE SCREW. IN ADDITION, IT WAS NOTED THAT IT WAS DIFFICULT TO VISUALLY IDENTIFY ANY DIFFERENCES. NO PATIENT CONSEQUENCE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021507 ↗
• MalfunctionFeb 24, 2026Complete Loss of Power

  IT WAS REPORTED THAT FURTHER REVIEW OF THE LOG FILES CAPTURED NO EXTERNAL POWER ALARMS WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU). THE MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD. THE CAUSE OF THE NO EXTERNAL POWER ALARMS WAS NOT IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434062 ↗
• MalfunctionFeb 10, 2026Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MOBILE POWER UNIT (MPU) ALARM. THE PATIENT REPORTED THAT THEY HAD IT PLUGGED INTO A SURGE PROTECTOR VERSUS A DIRECT WALL OUTLET. NO LOG FILES WERE AVAILABLE. THE PATIENT WAS TOLD TO WEAR BATTERIES AT NIGHT UNTIL MPU WAS EVALUATED AND REPAIRED. THE PATIENT WAS PROVIDED A LOANER MPU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306465 ↗
• MalfunctionFeb 5, 2026Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT'S MOBILE POWER UNIT (MPU) WOULD NOT POWER UP ON THREE DIFFERENT OUTLETS AT HOME AND AFTER CHECKING POWER CABLES. THE PATIENT WAS ABLE TO GET IT TO TURN ON AND BROUGHT IT IN FOR REPLACEMENT AS THE PATIENT WAS AFRAID TO CONTINUE TO USE IT. THE MPU WAS TESTED AND WAS WORKING FINE, PASSED SELF-TESTS AND LOOKED FINE BUT THE PATIENT DID NOT WANT IT BACK. THE MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD. A NEW MPU WAS GIVEN TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270781 ↗
• MalfunctionFeb 3, 2026Device Difficult to Setup or Prepare; Complete Loss of Power

  IT WAS REPORTED THAT DURING ROUTINE LOG FILE ANALYSIS, THE LOG FILES CAPTURED A LOSS OF POWER TO THE MOBILE POWER UNIT ON (B)(6) 2026. THE SYSTEM CONTINUED TO OPERATE AT THE SET SPEED AND WAS SUPPORTED BY THE SYSTEM CONTROLLER¿S BACKUP BATTERY UNTIL EXTERNAL POWER WAS RESTORED. THE MPU DID HAVE A V-LOCK CONNECTOR ON THE AC POWER CORD. THE AC POWER CORD CAME LOOSE AT THE WALL OUTLET. THE MPU WAS NOT REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251713 ↗
• MalfunctionFeb 2, 2026Complete Loss of Power

  IT WAS REPORTED THAT A REVIEW OF LOG FILES SHOWED POWER CABLE DISCONNECT AND NO EXTERNAL POWER WHILE CONNECTED TO MOBILE POWER UNIT (MPU) ON 15JAN2026, 17JAN2026 AND 21JAN2026. THIS WAS CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THE MPU DID NOT COME LOOSE AT THE WALL OUTLET OR FROM THE BACK OF THE UNIT. THE UNIT WAS EQUIPPED WITH A V-LOCK CONNECTOR ON THE AC POWER CORD. THERE WERE NOT ANY ENVIRONMENTAL CIRCUMSTANCES THAT WOULD HAVE AFFECTED AC POWER AT THE TIME OF THE EVENT. THE MPU REMAINED IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241622 ↗
• MalfunctionFeb 2, 2026Improper or Incorrect Procedure or Method; Complete Loss of Power

  IT WAS REPORTED THAT PATIENT ADMITTED ACCIDENTALLY DISCONNECTING MOBILE POWER UNIT (MPU) FROM OUTLET FORGETTING THEY WERE CONNECTED. THE PATIENT IMMEDIATELY SWITCHED TO BATTERY POWER BEFORE REALIZING THEY UNPLUGGED ACCIDENTLY. LOG FILES CAPTURED SEVERAL POWER LOSSES TO THE MOBILE POWER UNIT ON (B)(6) 2026. THE SYSTEM CONTINUED TO OPERATE AT THE SET SPEED AND WAS SUPPORTED BY BACKUP BATTERY UNTIL EXTERNAL POWER WAS RESTORED. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE MPU WAS EQUIPPED WITH A V-LOCK CONNECTOR ON THE AC POWER CORD. THE AC POWER CORD COME LOOSE AT THE WALL OUTLET OR FROM THE BACK OF THE UNIT. THE MPU REMAINED IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240727 ↗
• MalfunctionJan 20, 2026Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT WAS AT HOME UTILIZING THE MOBILE POWER UNIT (MPU) AND THE UNIT TURNED OFF. IT WAS BROUGHT TO THE HOSPITAL FOR EVALUATION AND COULD NOT BE CORRECTED. A NEW POWER CORD WAS TRIED ALONG WITH SEVERAL OUTLETS. THE MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD. THE PATIENT WAS GIVEN A NEW MPU. THE MPU HAD A V-LOCK CONNECTOR AND THE AC POWER CORD DID NOT COME LOOSE. THE OLD MPU WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120922 ↗
• MalfunctionJan 19, 2026Disconnection; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT'S MOBILE POWER UNIT (MPU) HAD BEEN ALARMING THE PAST FEW NIGHTS. LOG FILES WERE SENT FOR REVIEW. THE LOG FILES CAPTURED NO EXTERNAL POWER ALARMS AND MULTIPLE OTHER ASSOCIATED ALARM TYPES ON 26DEC2025 AND 27DEC2025. THIS WAS CAUSED BY INTERRUPTION OF POWER TO THE MPU. THERE WERE RANDOM POWER CABLE DISCONNECTS ON 29DEC2025 WHILE CONNECTED TO THE MPU ASSOCIATED WITH THE BLACK LEAD. THE ALARM SILENCE BUTTON WAS REPEATEDLY ACTIVATED ON 31DEC2025 BETWEEN 11:07 AND 11:16 BUT NO ALARMS AT THESE TIMES. THESE OCCURRED WHILE THE PATIENT WAS CONNECTED TO THE MPU. IT WAS COMMUNICATED ON 09JAN2026 THAT THERE WERE NO ENVIRONMENTAL CIRCUMSTANCES THAT WOULD HAVE AFFECTED AC POWER AT THE TIME OF THE EVENT. THE NO EXTERNAL POWER ALARMS HAD RESOLVED AFTER THE PATIENT SWITCHED OUTLETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24110100 ↗
• MalfunctionJan 12, 2026Disconnection; Mechanical Problem; Electrical Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT HAD A NURSE VISIT WITH INCREASED SHORTNESS OF BREATH AND WEIGHT GAIN OF 25LBS IN 4 DAYS. THE LOG FILE WAS SENT FOR ANALYSIS. THE LOG FILE CAPTURED POWER CABLE DISCONNECT, LOW POWER HAZARD AND NO EXTERNAL POWER ALARMS WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) ON (B)(6) 2025 AT 23:22. THERE WERE NO PUMP INTERRUPTION DURING THE EVENTS AS THE SYSTEM CONTROLLER'S EMERGENCY BACKUP BATTERY (EBB) FUNCTIONED AS INTENDED. THE ALARMS RESOLVED AFTER THE MPU REGAINED POWER. BASED ON THE LOG FILE, THE MECHANICAL CIRCULATORY SYSTEM (MCS) EQUIPMENT OPERATED AS INTENDED ELECTRONICALLY AND MECHANICALLY. IT WAS LATER REPORTED ON 02JAN2026, THAT THE MPU HAD A V-LOCK CONNECTOR ON THE ALTERNATING CURRENT (AC) POWER CORD. THE PATIENT DID NOT RECALL IF THE AC POWER CORD CAME LOOSE FROM THE WALL OUTLET OR BACK OF THE MPU. THE PATIENT WAS UNSURE BUT BELIEVED THAT A BRIEF LOSS OF POWER TO THE HOUSE MAY HAVE AFFECTED THE AC POWER AT THE TIME. THE MPU WAS NOT EXCHANGED.

  Patient problems: Increased Respiratory Rate; No Clinical Signs, Symptoms or Conditions; Weight Changes

  MAUDE report 24041260 ↗
• MalfunctionJan 7, 2026Disconnection; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POWER CABLE DISCONNECTS WHEN CONNECTED TO THE MOBILE POWER UNIT (MPU). THE MPU WAS EXCHANGED. UPON CLOSER INSPECTION, THERE APPEARS TO BE BITE MARKS ON THE PATIENT CABLE AND AC POWER CORD. PUMP FUNCTIONED AS INTENDED. IT WAS SAID NO ADDITIONAL INFORMATION WOULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23999744 ↗
• MalfunctionJan 2, 2026Device Difficult to Setup or Prepare; Complete Loss of Power

  IT WAS REPORTED THAT THERE WAS LOSS OF AC POWER WHILE CONNECTED TO MOBILE POWER UNIT (MPU) POWER AND LOG FILES WERE SUBMITTED FOR EVALUATION. IT APPEARED THAT THERE WAS NO EXTERNAL POWER EVENTS WERE RECORDED ON 14DEC2025, 15DEC2025, AND 16DEC2025 WHILE CONNECTED TO MPU POWER. THE PATIENT WAS USING THE LOCKING VERSION OF THE MPU AC POWER CORD. THE PATIENT WAS RE-EDUCATED THE PATIENT ON PROPER USE OF THE MPU. THE AC POWER CORD CAME LOOSE AT THE WALL OUTLET. THE MPU WAS NOT EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944871 ↗
• MalfunctionDec 30, 2025Material Twisted/Bent; Insufficient Device Problem Information; Material Twisted/Bent; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INTERMITTENT ALARMS ON THEIR MOBILE POWER UNIT (MPU). THEY WERE ASKED TO NOT USE THE MPU AND TO COME INTO THE CLINIC WITH THAT MPU FOR FURTHER ASSESSMENT. THE PATIENT CABLE PORTION OF THIS MPU WAS GROSSLY TWISTED AND COMPROMISED. UPON INTERROGATING THEIR DEVICE, MANY ¿NO EXTERNAL POWER¿ ALARMS WERE IDENTIFIED (26). THE OLD MPU WAS TAKEN FROM THE PATIENT, AND THEY WERE ISSUED A NEW MPU. LOG FILES WERE SUBMITTED FOR EVALUATION WHICH CAPTURED SEVERAL SHORT PERIODS OF ¿NO EXTERNAL POWER¿ EVENTS THROUGHOUT THE LOG. SOME OF THESE PERIODS INVOLVED LOW VOLTAGE HAZARDS AS WELL. IT WAS NOTED THAT THE RSOC VOLTAGES ON BOTH POWER LEADS WHILE USING THE MPU WERE ROUTINELY AT 11V DURING THESE ALARMS WHICH IS BELOW SPECIFICATION AND LIKELY THE REASON FOR THE ALARMS. THE EMERGENCY BACKUP BATTERY (EBB) WAS ENABLED 12 TIMES TO SUPPORT THE PUMP DURING THESE NO EXTERNAL POWER EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927531 ↗
• MalfunctionDec 29, 2025Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE LOSSES OF EXTERNAL POWER THAT WAS SUSPECTED BY CLINICIANS TO BE DUE TO USER ERROR. THE PATIENT WAS PROVIDED REEDUCATION AND LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILE CAPTURED INTERMITTENT NO EXTERNAL POWER ALARM(S) AND MULTIPLE OTHER ASSOCIATED ALARM TYPES BETWEEN (B)(6) 2025 AND (B)(6) 2025. THIS WAS CAUSED BY POWER TO THE MOBILE POWER UNIT (MPU) BEING BRIEFLY INTERRUPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915461 ↗
• MalfunctionDec 29, 2025Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERAL LOW VOLTAGE EVENTS. THEY TOLD THE PATIENT TO CONNECT TO POWER WHILE CONNECTED TO MOBILE POWER UNIT (MPU). ON (B)(6) 2025 AT 8:30 PM THE PATIENT PLUGGED INTO HER MPU AND THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) WENT TO EMERGENCY BACKUP BATTERY (EBB). IT FUNCTIONED PROPERLY WHEN IT WAS SWITCHED TO 14 VOLT LITHIUM-ION BATTERIES. THEY TRIED TO TROUBLESHOOT OVER THE PHONE BUT WAS UNABLE TO GET IT TO WORK. THE PATIENT BROUGHT IN THE MPU TO TEST. THERE WAS NO DAMAGE TO THE MPU OR THE PATIENT CABLES. THE GREEN LIGHT CAME ON APPROPRIATELY AND WAS ABLE TO CHARGE EBB IN THE BACKUP SYSTEM CONTROLLER. HOWEVER, WHEN HOOKED TO PATIENT'S RUNNING SYSTEM CONTROLLER, THE LVAD CONTROLLER ALARMED "CONNECT TO POWER IMMEDIATELY" "BACKUP BATTERY." THERE WERE NO ALARMS ON MPU AND STILL SHOWED A GREEN LIGHT. THEY TESTED WITH A BACKUP CONTROLLER AND LOANER MPU TO TROUBLESHOOT THE ISSUE. WHILE CONNECTED TO MPU, CONTROLLER ALARMED AND CONNECT TO POWER WAS VISUAL ON SCREEN. THE PATIENT LEFT CLINIC WITH LOANER MPU. THE CAUSE OF THE ALARM WAS NOT IDENTIFIED AND DID NOT RESOLVE WITH THE PATIENT'S MPU. THERE WERE NO ALARMS WHEN PLACED ON BATTERIES AND ALSO NO ALARMS WHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915442 ↗
• MalfunctionDec 23, 2025Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT LOG FILE REVIEW WAS REQUESTED WHICH REVEALED A NO EXTERNAL POWER EVENT WHILE ON MOBILE POWER UNIT (MPU) POWER. THE EVENT LASTED 45 SECONDS. THE EMERGENCY BACKUP BATTERY (EBB) POWERED THE SYSTEM UNTIL POWER WAS RESTORED. BECAUSE THE PATIENT WAS VERY SICK., IT WAS NOTED THE PATIENT MAY NOT REMEMBER IF THEY LOST POWER OR DUAL POWER CABLE DISCONNECTED. IT WAS UNKOWN IF THE MPU HAD A V-LOCK CONNECTOR. THE MPU WAS NOT EXCHANGED. THE PATIENT WAS UNSURE WHAT HAPPENED AS THEY HAVE DEMENTIA, BUT IT WAS NOTED THEY ALSO NOTED A POWER OUTAGE, HOWEVER THEY WERE NOT SURE WHEN THE POWER OUTAGE HAPPENED IN RELATION TO THE MPU LOSS OF POWER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881483 ↗
• MalfunctionDec 22, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A YELLOW WRENCH ALARM ON THE MOBILE POWER UNIT (MPU). THE MPU WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874170 ↗
• MalfunctionDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MOBILE POWER UNIT (MPU) HAD A CONSTANT, AUDIBLE ALARM. EVEN AFTER REPLACING THE BATTERIES, THE ALARM PERSISTED. A LOANER WAS REQUESTED WHILE THE MPU WAS RETURNED FOR EVALUATION AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871717 ↗
• MalfunctionDec 18, 2025Electrical Power Problem; No Apparent Adverse Event; Complete Loss of Power; Electrical Power Problem; No Apparent Adverse Event; Complete Loss of Power

  THE MPU DID HAVE A V-LOCK CONNECTOR ON THE AC POWER CORD. THE AC POWER CORD DID NOT COME LOOSE AT THE WALL OUTLET. THE AC POWER CORD DID NOT COME LOOSE FROM THE BACK OF THE UNIT. THE PATIENT STATED POWER WENT OUT AND SWITCHED TO BATTERIES. THE PATIENT FOUND OUT THE OUTLET THE MPU CONNECTED TO WAS OUT AND SWITCHED THE MPU TO DIFFERENT OUTLET. THEY INTENDED TO HAVE AN ELECTRICIAN COME TO THEIR HOME TO CHECK. THE MPU WAS NOT EXCHANGED/REMOVED FROM SERVICE. LOG FILES WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842296 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060040, P160054. One submission often covers many models, so check the product and lot details in each record.

• Z-2519-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts
• Z-2518-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left
• Z-2520-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Stan
• Z-0506-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF
• Z-0508-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate II Controller (standalone) Model/Catalog Number: 106017, HeartMate II Pocket Controller, US; 106762, HeartMate II Pocket Controller, U
• Z-0505-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS;
• Z-0507-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate II LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II LVAS
• Z-2290-2025 · Jun 23, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assis
• Z-2583-2024 · Jun 25, 2024 · Open, Classified
  HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Ki
• Z-1921-2024 · May 8, 2024 · Open, Classified
  Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
• Z-1693-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
• Z-1692-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
• Z-1300-2024 · Feb 19, 2024 · Open, Classified
  HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate
• Z-1301-2024 · Feb 19, 2024 · Open, Classified
  HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graf
• Z-0842-2024 · Jan 3, 2024 · Open, Classified
  1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate T

…and 15 more.