HeartMate 3™ 106524USRecalls & reported problems

Summary

The FDA's MAUDE database contains 207 adverse event reports that list this exact device (DI 05415067039323), received between Dec 11, 2024 and Sep 30, 2026 — classified as 123 deaths, 63 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (52 reports).

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

17 other recalls cover devices cleared under the same FDA submission (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. May 13, 2026Open, Classified

   Due to 11 volt Backup Battery failures.

   Z-2518-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 207 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Contamination /Decontamination Problem

  It was reported that the patient experienced a Driveline Communication Fault on (b)(6)2026. The patient panicked and switched to their backup System Controller. The patient stated that after a few minutes, the backup Controller had the same error, so they switched back to their primary Controller. Review of Log Files from the primary Controller found single Communication Faults (COMM A) starting at 15:53 on (b)(6)2026 that continued until the Controller was exchanged at 15:55. Review of the backup Controller Log File showed the Driveline was connected at 15:55 on (b)(6)2026 and COMM A Faults reoccurred at 17:39, with the patient switching back to the original Controller at 17:46. No further COMM faults were noted in the Log Files after the patient switched back to the original primary Controller. The customer stated that there were no visible cracks, slits, or damage to Pump or Modular Cables. However, some debris was noted around the yellow line at the Modular Cable-Pump Cable connector. That debris was cleaned. The patient was then provided a new System Controller and Modular Cable. There were no further alarms reported following the exchange to the new Controller and new Modular

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947208 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Hemodynamic instability; Thrombosis/Thrombus

  MAUDE report 50936065 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Stroke/CVA; Thromboembolism

  MAUDE report 50935955 ↗
• InjurySep 28, 2026Mechanical Problem; Overheating of Device; Pumping Stopped; Infusion or Flow Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50926389 ↗
• MalfunctionSep 28, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923776 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away. The cause of death was not provided. The patient detached from power. An autopsy would not be performed. The Pump was not explanted.

  Patient problems: Insufficient Information

  MAUDE report 50916454 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had black bloody stool on (b)(6)2026. The device operated as expected. The event was not considered device or therapy related. The cause of the event was severe constipation. Treatment included bowel regimen. The event resolved.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50914811 ↗
• InjurySep 28, 2026Mechanical Problem; Decreased Pump Speed; Infusion or Flow Problem

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 50914640 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Ischemia Stroke; Tachycardia

  MAUDE report 50906272 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Atrial Fibrillation

  MAUDE report 50902980 ↗
• MalfunctionSep 25, 2026Mechanical Problem; Overheating of Device; Gas/Air Leak; Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902948 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Arrest

  MAUDE report 50900373 ↗
• MalfunctionSep 25, 2026Electromagnetic Interference

  It was reported that the patient was being worked up for a heart transplant, during which a right heart catheterization (RHC) was performed. A CardioMEMs (CMEMS) reading was attempted during the RHC but a signal was not able to be acquired in the cath lab. The representative shared an image that revealed that the sensor was rotated onto its side, roughly parallel to the spine, just above the left edge of the Left Ventricular Assist Device (LVAD) and below the pacer or implantable cardioverter-defibrillator (ICD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899825 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Patient problems: Hemodynamic instability

  MAUDE report 50899591 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was admitted from the emergency room for gastrointestinal (GI) bleed on (b)(6) 2026. The patient initially presented to an outside hospital emergency room with a hemoglobin (hg of 6.5 and received 2 units of blood and was discharged at that time. The patient then presented to the implanting facility status post large volume dark bowel movement. The patient's hg/hematocrit (hct) was 9.2 g/dL and 28.6%, respectively. The patient did not receive any blood products. The patient's international normalized ratio (INR) was 1.4 at that time. On (b)(6) 2026, the patient underwent an esophagogastroduodenoscopy that showed a bleeding duodenal ulcer and gastritis. A proton pump inhibitor (PPI) was added. The patient's INR goal was decreased to 1.5-2.0, and the patient was deemed appropriate for discharge on (b)(6) 2026.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 50899397 ↗
• InjurySep 25, 2026Infusion or Flow Problem

  It was reported that the Log Files were sent for analysis. The patient experienced increasing fatigue over the past few days, with shortness of breath, nausea, and vomiting. Low-flow events on interrogation appeared to correlate with Implantable Cardioverter-Defibrillator (ICD) shocks. Device interrogation was pending. The healthcare profession reported concern that the patient may have been experiencing arrhythmias for several days in conjunction with hypovolemia. It appeared that The Log File captured some intermittent Low Flow Events on (b)(6) 2026. The calculated flow appears to have fluctuated below the alarm threshold of 2.0 LPM during the events. The Log File contained low flow estimates as well as sustained low flow hazard events when the calculated Pulsatility Index (PI) was dynamic and elevated.

  Patient problems: Arrhythmia; Dyspnea; Fatigue; Nausea; Shock; Vomiting

  MAUDE report 50897672 ↗
• InjurySep 24, 2026Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Tachycardia

  MAUDE report 50886263 ↗
• InjurySep 24, 2026Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had zero flow on the night of (b)(6) 2026 and the next morning. Log Files were sent for review. The Event Log captured a drop in flow on(b)(6) 2026 around 23:00 with estimated flows hovering around the 2.4 to 2.5 LPM range. These lower flows continued throughout most of the Log with zero flow noted on (b)(6) 2026 at 23:40. Flow recovered back into the 2 LPM range a few minutes later with continued Low Flow Events. It was also noted that the fixed speed was changed multiple times during these Low Flow periods sometimes causing Low Speed Advisory Events. By the end of the data capture, the estimated flows were back into the 4 LPM range. The patient had an acute hypotension and loss of Left Ventricular Assist Device (LVAD) flows (down to 1.7L). A transesophageal echocardiogram (TEE) showed left ventricle (LV) completely decompressed/empty, right ventricle (RV) blown out/not moving flow. Carbon dioxide (CO2) was up to 80s. Emergent Right Ventricular Assist Device (RVAD) circuit exchanged with Oxygenator. Ventricular fibrillation was noted and 1 shock was performed to normal sinus rhythm (NSR). LVAD flows restored, with RV/LV normal filling/size. Total r

  Patient problems: Low Blood Pressure/ Hypotension; Pulmonary Edema; Pulmonary Embolism; Ventricular Fibrillation

  MAUDE report 50885600 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was admitted on (b)(6) 2026 and (b)(6) 2026 for an ongoing Driveline infection. On (b)(6) 2026, swab culture grew 3+ Methicillin-Susceptible Staphylococcus Aureus (MSSA). Computed tomography (CT) was also performed, showing a mild amount of stranding in the left lower quadrant subcutaneous abdominal wall, around the Driveline wire. No fluid collection. Otherwise, no acute abnormality in the chest, abdomen, and pelvis. In (b)(6) 2026 a more recent swab grew multiple corynebacteria, including an amycolatum species with resistance to oral antibiotics, a CT on (b)(6) 2026 showed no focal fluid collection or fat stranding surrounding the Driveline. Mild skin thickening near the entry point of the Driveline could be related to cellulitis. The plan was to continue cefadroxil for ongoing MSSA suppression which would likely be indefinite antibiotic therapy.

  Patient problems: Bacterial Infection

  MAUDE report 50885521 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after implant, the patient returned to the operating room (OR) after experiencing arrhythmia and required emergent placement on extracorporeal membrane oxygenation (ECMO) with right ventricular (RV) failure. An additional Left Ventricular Assist Device (LVAD) was implanted as a Right Ventricular Assist Device (RVAD).

  Patient problems: Arrhythmia; Heart Failure/Congestive Heart Failure

  MAUDE report 50883726 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Ascites; Heart Failure/Congestive Heart Failure; Hemodynamic instability; Peripheral Edema; Renal Failure

  MAUDE report 50873219 ↗
• InjurySep 13, 2026Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50747571 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50676252 ↗
• DeathAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient expired. The cause of death was not provided. No Log Files were available for review. Whether the patient's outcome was considered to be device or therapy related was not provided. An autopsy was not performed, and the device was not explanted for evaluation.

  Patient problems: Insufficient Information

  MAUDE report 50522338 ↗
• DeathAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's course was reported to be complicated by cardiac tamponade despite multiple chest closure/washouts. The patient had cardiogenic shock from (b)(6) 2026 until (b)(6) 2026 , Acute Respiratory Distress Syndrome (ARDS) requiring veno-venous extracorporeal membrane oxygenation (VV ECMO) occurred from (b)(6) 2026 until (b)(6)2026, and tracheostomy placement occurred on (b)(6) 2026. The patient was later found to have profound lactic acidosis with septic shock due to gram-negative rod bacteremia on 19July2026, mesenteric ischemia on 20Jul2026, severe coagulopathy on 20Jul2026, and acute renal failure on CRRT that was deemed unsurvivable from 30Jun2026 until 20Jul2026. After discussion with the family at the bedside, the decision was made to transition to comfort care to alleviate patient suffering in the setting of a non-survivable condition. The patient ended up passing away due to septic shock as a result of gram-negative rod bacteremia. The outcome was considered therapy related. The Pump was not explanted. The device operated as expected.

  Patient problems: Bacteremia; Cardiac Tamponade; Cardiogenic Shock; Ischemia; Renal Failure; Septic Shock

  MAUDE report 50461897 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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-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-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-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-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-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-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
• Z-0746-2020 · Dec 2, 2019 · Terminated
  HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, R
• Z-2348-2019 · Mar 30, 2019 · Terminated
  Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

…and 2 more.