HeartMate Touch™ HMT1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 05415067032058), received between Nov 9, 2021 and Sep 28, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (21 reports).

1 FDA recall record name this device's identifier, 1 still open.

31 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jan 3, 2024Open, Classified

   Due to software and controller systems that results in unexpected pump start or pump stop.

   Z-0842-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Communication or Transmission Problem

  It was reported that during preparation of a HeartMate 3 system in the operating room, communication with the system was lost after the Pump had been primed and while the team was attempting to turn it off. The red Line never completed across the screen and the Pump started back up. Troubleshooting was performed, including disconnecting the Bluetooth adapter, rebooting the adapter, and attempting to reconnect the system. Communication was temporarily restored; however, the connection was lost again during a subsequent priming attempt. The entire system cart, including the Power Module, HM Touch iPad, Patient Cable, and Bluetooth adapter, was sent to biomedical engineering team for evaluation. The equipment reportedly passed testing and was returned for clinical use. However, after being connected to a patient in the intensive care unit, communication was again lost after approximately five minutes of operation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915584 ↗
• MalfunctionSep 24, 2026Communication or Transmission Problem

  It was reporting that after Pump preparation was completed, the HeartMate Touch (HMT) abruptly lost connection to the System Controller. All connections were checked and secured. The Bluetooth connection was stable. Extended silence was noted to be disengaged. There were attempts to reconnect to the Controller, but the Screen would not verify the connection. Images were submitted of the issue. A new HMT was obtained and there were no further issues at that time. During the case, multiple attempts were made to start the Pump, but the command would not go through and the Pump would not start. The Power was stable at 0.8W. Usual alarms were present on the Controller, including Pump Off Alarms, Low Flow Alarms, and Backup Battery Not Installed Alarms. A new Ventricular Assist Device (VAD) cart was obtained with a HMT, a Bluetooth adapter, and a new System Controller. A Controller exchange was performed. No further connectivity issues or alarms occurred after the exchange. The customer requested a replacement Controller.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887183 ↗
• MalfunctionFeb 2, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE HEARTMATE TOUCH (HMT) WAS NOT RECOGNIZING TOUCH MULTIPLE TIMES DURING PUMP PREP IN THE OPERATING ROOM (OR). THE SCREEN WAS NOT SENSITIVE TO TOUCH ATTEMPTS TO PRIME THE PUMP. THE APP WAS CLOSED OUT AND OPENED AGAIN. THE APP WORKED INTERMITTENTLY WITH TOUCHES ON THE TABLET, AND THE HMT WAS TAKEN TO BIOMED FOR TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231128 ↗
• MalfunctionDec 29, 2025Premature Discharge of Battery; Failure to Interrogate; Manufacturing, Packaging or Shipping Problem; Failure to Interrogate; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE HOSPITAL ORDERED A HEARTMATE (HM) TOUCH COMMUNICATION SYSTEM AND THE IPAD WAS NOT ABLE TO LINK TO THE BLUETOOTH ADAPTER AND WELL AS KEEP CHARGE. TROUBLESHOOTING WAS PERFORMED AND IT STILL DID NOT WORK WHEN TRIED TO CONNECT TO A DIFFERENT BLUETOOTH ADAPTER. THE BLUETOOTH ADAPTER IN THE KIT WAS ABLE TO CONNECT TO A DIFFERENT HM TOUCH. THE CENTER WOULD BE RETURNING THE HM TOUCH COMMUNICATION SYSTEM FOR OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908212 ↗
• MalfunctionDec 4, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE SITE EXPERIENCED A LOST CONNECTION BETWEEN THE HEARTMATE TOUCH AND THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) DURING PUMP PREPARATION. THE CONNECTION WAS RE-ESTABLISHED TO END THE PUMP PREPARATION, AND THE HEARTMATE 3 WAS IMPLANTED WITHOUT ANY OTHER ISSUES. THE PATIENT LATER EXPERIENCED LOW FLOW AND PUMP OFF ALARMS. THE PUMP WAS CONFIRMED TO BE OFF. THE HEARTMATE TOUCH READ BLANK REVOLUTIONS PER MINUTE (RPM), 0.0 LITERS PER MINUTE, AND POWER AT 1.4 WATTS. THE SITE RECEIVED AN ERROR MESSAGE WHEN THEY ATTEMPTED TO CHANGE THE RPM. THE SITE WAS NOT ABLE TO START THE STOPPED PUMP USING THE HEARTMATE TOUCH, CHANGING SYSTEM CONTROLLERS, OR POWER CYCLING BY DISCONNECTING THE DRIVELINE AT THE SYSTEM CONTROLLER. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR AN URGENT PUMP EXCHANGE. LOG FILES WERE SENT FOR REVIEW. THE LOG FILES DID NOT DISPLAY ANY USABLE DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720574 ↗
• MalfunctionJul 16, 2025Overheating of Device; Failure to Power Up; Overheating of Device; Failure to Power Up

  IT WAS REPORTED THAT THE HEARTMATE IPAD DID NOT TURN ON DESPITE BEING FULLY CHARGED. THE IPAD WAS ABLE TO BE TURNED ON ONE HOUR LATER BUT WAS WARM TO THE TOUCH. LATER IN THE DAY, MULTIPLE ATTEMPTS WERE MADE TO TURN ON THE HEARTMATE TOUCH IPAD, BUT IT DID NOT TURN ON AND FUNCTION. MULTIPLE ATTEMPTS WERE MADE TO RESTART THE DEVICE WITH NO SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523003 ↗
• MalfunctionJun 26, 2025Failure to Power Up; No Apparent Adverse Event; Failure to Power Up; No Apparent Adverse Event

  FURTHER REVIEW OF THE SUBMITTED LOG FILES REVEALED THAT THE PUMP STOP EVENT APPEARED TO BE THE RESULT OF THE SYSTEM CONTROLLER SENDING A COMMAND TO DISABLE PUMP AUTO-START, PER DESIGN, DUE TO THE PUMP RESETTING WHILE THE SET SPEED WAS BELOW 4000 REVOLUTIONS PER MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340852 ↗
• MalfunctionJun 20, 2025Failure to Interrogate; No Apparent Adverse Event; Failure to Interrogate; No Apparent Adverse Event

  IT WAS REPORTED THAT THE LOG FILES WERE PROVIDED FOR THE SYSTEM CONTROLLER EXCHANGE AND IT WAS DUE TO A BLANK SCREEN ON THE HEARTMATE TOUCH DEVICE. AFTER THE SYSTEM CONTROLLER EXCHANGE IT LOOKED AS THOUGH THE DEVICE WAS FUNCTIONING AS INTENDED. THERE WERE SOME CONCERNS ABOUT BLANKING FLOWS BUT THE FLOW LOOKED SOLID IN THE LIMITED DATA PROVIDED. IT WAS REQUESTED THAT THE LOG FILES FROM THE EXCHANGED SYSTEM CONTROLLER BE PROVIDED AS IT MAY HAVE MORE PERTINENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301422 ↗
• MalfunctionJun 16, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE LEFT VENTRICULAR ASSIST DEVICE CART, SPECIFICALLY WITH THE IPAD SCREEN, WHICH WOULD NOT TURN ON. UPON INSPECTION, THE TECHNICIAN WAS NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE ISSUE. ADDITIONAL TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE DID NOT RESOLVE. THE SCREEN WAS REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212523 ↗
• MalfunctionJun 11, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE SYSTEM CONTROLLER LOST CONNECTION WITH THE HEARTMATE TOUCH TABLET. THE TABLET SHOWED "END SESSION" AS IF THE SYSTEM CONTROLLER WAS DISCONNECTED. "END SESSION" WAS PUSHED AND WAITED FOR THE CONNECTION TO RESUME. THE SYSTEM CONTROLLER WAS NOT CONNECTING AND BLUETOOTH CONNECTION WAS LOST. THE BLUETOOTH ADAPTER WAS UNPLUGGED AND PLUGGED BACK IN. THE HEARTMATE TOUCH APP WAS CLOSED OUT, AND THEN BLUETOOTH CONNECTION WAS ESTABLISHED AGAIN AND THEY WERE ABLE TO MOVE ON WITH THE PROCEDURE. WHEN THE PUMP WAS TURNED ON THE "PROCESSING..." SCREEN STAYED ON LONGER THAN USUAL. SYSTEM CONTROLLER ALARMED DUE TO LOSS OF CONNECTION AND LOSS OF EXTENDED ALARM SILENCE. RED HEART, DRIVELINE DISCONNECT SINCE WE WERE NOT FULLY ASSEMBLED AS NORMAL PART OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185674 ↗
• MalfunctionApr 22, 2025Failure to Charge; Failure to Interrogate; Failure to Power Up; Failure to Charge; Failure to Interrogate; Failure to Power Up

  IT WAS REPORTED THAT THE HEARTMATE TOUCH COMMUNICATION SYSTEM WOULD NOT TURN ON OR CHARGE, AND MULTIPLE CHARGERS WERE TRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885894 ↗
• MalfunctionApr 2, 2025Failure to Interrogate; Device Difficult to Setup or Prepare; Failure to Interrogate; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE HEARTMATE TOUCH (HMT) WOULD NOT CONNECT WHEN PRESSING THE GRAY BUTTON ON THE SERIAL ADAPTER. IT WAS ATTEMPTED WITH A SECOND SERIAL ADAPTER WITH THE SAME ISSUE OCCURRING. THE CLINIC TRIED POWER CYCLING THE HMT AND THERE WAS STILL NO CONNECTION. IT WAS NOTED THAT IT WAS ABLE TO BE CONNECTED IN CLINIC AND THE CUSTOMER WOULD CONTINUE TO MONITOR. NO PRODUCT WOULD RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755383 ↗
• MalfunctionApr 1, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT HEARTMATE TOUCH SCREEN WAS BLANK. IT WAS CHARGED ALL EVENING. THERE WAS SOMETHING ON AS THE SCREEN LIT UP AND THE NOISE WHEN THE SCREEN WAS LOCKED STILL OCCURRED, BUT THE SCREEN WAS BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21744131 ↗
• MalfunctionDec 19, 2024Communication or Transmission Problem; No Apparent Adverse Event; Communication or Transmission Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT HAD DEGREE OF RECOVERY. FLOWS SOMETIMES DIPPED TO LESS THAN 2.5 LITERS PER MINUTE (LPM) BECAUSE OF THIS. CONTROLLER WAS EXCHANGED TO 2.0 LPM SOFTWARE. COULDN'T USE THE LOW FLOW ALARM THRESHOLD AS IT WAS NOT WORKING. THE APP CRASHED EVERY TIME THE BLUETOOTH ADAPTER WAS CONNECTED FROM THE LIST. A NEW 2.0 LPM SYSTEM CONTROLLER WAS USED FROM THE SHELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20982492 ↗
• MalfunctionNov 20, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE HEARTMATE TOUCH (HMT) SCREEN FROZE AND DUPLICATED IMAGES. THE SITE RESTARTED THE HMT AND ISSUES CONTINUED. THE CENTER REQUESTED A REPLACEMENT HMT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20741190 ↗
• MalfunctionOct 29, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE NURSING STAFF ON THE THIRD EAST WARD COULD NOT CONNECT THE PATIENT VIA BLUETOOTH. THEY SWAPPED THE EQUIPMENT TROLLY TO A DIFFERENT SYSTEM AND CONNECTED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558607 ↗
• MalfunctionOct 29, 2024Communication or Transmission Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558315 ↗
• MalfunctionOct 17, 2024Premature Discharge of Battery; Failure to Charge; Premature Discharge of Battery; Failure to Charge

  IT WAS REPORTED THAT HEARTMATE TOUCH WAS UNABLE TO HOLD CHARGE; SAME UNIT WAS THEN UNABLE TO TURN ON. THE UNIT WAS ATTEMPTED TO RECHARGE, STILL REPORTED INTERMITTENT OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20475646 ↗
• MalfunctionSep 12, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE HEARTMATE TOUCH (HMT) WAS NOT CONNECTING TO ANY SYSTEM CONTROLLER. TROUBLESHOOTING WAS PERFORMED, THE APP WAS RESTARTED, THE IPAD WAS TURNED OFF AND ON, THE ADAPTER WAS UNPLUGGED, A NEW WIRELESS ADAPTER WAS TRIED, AND THE PATIENT CABLE WAS CHANGED OUT. THE HMT WOULD STILL NOT CONNECT TO THE SYSTEM CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206249 ↗
• MalfunctionSep 11, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE HEARTMATE TOUCH (HMT) FLOW GRAPH WAS ABNORMAL. THE LOG FILES WERE REVIEWED BUT DID NOT OFFER AN EXPLANATION FOR THE ABNORMAL FLOW GRAPH ON THE HMT. IT WAS STATED BY A TEAM MEMBER WHO WAS IN THE OPERATING ROOM (OR) AT THE TIME THAT THEY WERE ALREADY DONE WITH THE IMPLANT BUT STILL IN THE OR WAITING FOR TRANSPORT TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT AND THEIR AND HEMODYNAMICS WERE STABLE. IT WAS STATED THAT NOTHING WAS HAPPENING TO THE PATIENT DURING THE ABNORMAL FLOW GRAPH. THERE WAS NOTHING TO INFLUENCE THE PARAMETERS OR THE TREND FLOW GRAPH. IT WAS COMMUNICATED THAT THE ISSUE RESOLVED ON ITS OWN. THE WAVEFORM WENT BACK TO STRAIGHT AND CONTINUOUS WHILE IN THE OR. THE HMT REMAINED IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193578 ↗
• MalfunctionSep 4, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED WHILE TRYING TO CONNECT THE SYSTEM CONTROLLER TO THE HEARTMATE (HM) TOUCH, THE PRODUCTS WOULD NOT SYNCH OR RECOGNIZE THAT THE PATIENT WAS CONNECTED. THE HM TOUCH WAS TURNED OFF AND THEN ON AGAIN, WHICH RESOLVED THE ISSUE. THE PRODUCT WORKED APPROPRIATELY AFTER BEING REBOOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137386 ↗
• MalfunctionJul 17, 2024Communication or Transmission Problem; No Apparent Adverse Event; Communication or Transmission Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS ATTEMPTED TO BE CONNECTED TO THE HM TOUCH MONITOR LOCATED IN (B)(6) OUTPATIENT CLINIC. WHEN CONNECTING WHITE-TO-WHITE CABLES TO THIS PATIENT'S SYSTEM CONTROLLER, THE CONTROLLER CONNECTION SCREEN DID NOT APPEAR. THIS PATIENT CABLE HAD BEEN USED ON ANOTHER PATIENT PREVIOUSLY AND WAS NOT DEEMED TO BE THE ISSUE. THE HEARTMATE TOUCH APP AND THE HEARTMATE TOUCH (HMT) WERE BOTH HARD RESTARTED. THE SYSTEM CONTROLLER WAS STILL DRAWING POWER THROUGH THIS CONNECTION, NOT LEADING TO A POWER CABLE DISCONNECT WHILE ATTACHED. ONCE TROUBLESHOOTING WAS COMPLETE, THE CENTER OPTED TO EXCHANGE THE SYSTEM CONTROLLER WITH A NEW PRIMARY SYSTEM CONTROLLER. ON THIS NEW SYSTEM CONTROLLER, THE CONNECTION STARTED UP IMMEDIATELY. THE SYSTEM CONTROLLER WOULD BE RETURNED FOR ANALYSIS. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-04379 (SYSTEM CONTROLLER)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767661 ↗
• MalfunctionJul 17, 2024Failure to Charge; No Display/Image; Failure to Charge; No Display/Image

  THE ISSUE RESOLVED AFTER READJUSTING/ MANIPULATING THE POWER CORD. THE CAUSE OF THE BLACK SCREEN WAS UNABLE TO BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766556 ↗
• MalfunctionJul 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED FROM CARDIOVASCULAR INTENSIVE CARE UNIT THAT ONE OF THE MONITORS WAS FROZEN. INFORMATION WAS ADDITIONALLY PROVIDED THAT IT SEEMED TO BE WORKING FINE OTHER THAN IT LOOKED LIKE SOMETHING MAYBE HIT THE SCREEN AND WAS CAUSING A MARK/FLASHING ON THE HEARTMATE TOUCH MONITOR SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659145 ↗
• MalfunctionJun 3, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PREPARATION, THE HEARTMATE TOUCH LOST CONNECTION WITH THE SYSTEM CONTROLLER WHILE PRIMING THE PUMP. IT COULD NOT BE RECALLED IF THE MESSAGE SAID "CONNECTION LOST TO CONTROLLER OR CONNECTION LOST TO ADAPTER". THE SCREEN SHOWED "END SESSION" AND THERE WAS NO LONGER ANY INFORMATION FROM THE SYSTEM CONTROLLER TO THE HEARTMATE TOUCH SCREEN. THE STAFF HIT "END SESSION" AND THE SCREEN SHOWED A CONNECTION TO THE HEARTMATE TOUCH WAS PRESENT ON THE SCREEN. THEY HIT "CONTINUE" ON THE HEARTMATE TOUCH SCREEN TO REESTABLISH CONNECTION AND THE SCREEN SHOWED THE MONITOR VIEW AND THE PUMP WAS RUNNING IN PRIME. THE COUNTDOWN FOR THE PRIME WAS NO LONGER VISIBLE. THE PRIME WAS COMPLETED BY STOPPING THE PUMP WITH THE "STOP PUMP" BUTTON. THERE WAS NO INTERRUPTION TO THE PRIMING OF THE PUMP AND THERE WERE NO OTHER ISSUES NOTED DURING THE REST OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19450643 ↗

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-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-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-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-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-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-2291-2025 · Jun 23, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (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-1570-2025 · Mar 13, 2025 · Open, Classified
  HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
• 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-1692-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
• Z-1693-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, 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

…and 16 more.