Thoratec® HeartMate 3™ 10005877Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00813024013082), received between Feb 8, 2019 and Sep 20, 2024 — classified as 11 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (11 reports).

18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT A HEARTMATE3 (HM3) WAS IMPLANTED IN A PATIENT VIA BILATERAL THORACOTOMY APPROACH WITH CARDIOPULMONARY BYPASS (CPB) SUPPORT. THE HM3 PUMP WAS PREPPED ON THE BACK TABLE. THE LOCKING MECHANISM WAS VERIFIED TO BE ADEQUATELY LOCKING BY VERIFYING THE LOCKING TABS WERE ABUTTING THE INFLOW CANNULA. THE MINI APICAL CUFF WAS SUTURED ONTO THE LEFT VENTRICLE (LV) VIA PLEDGETED SUTURES AND RUNNING PROLENE. THE PUMP WAS LOCKED SECURELY IN THE MINI APICAL CUFF WITHOUT YELLOW LINES VISIBLE ON THE LOCKING MECHANISM. THIS WAS VERIFIED BY THE ABSENCE OF THE YELLOW MARKER AND INABILITY TO ROTATE THE PUMP ONCE AFFIXED TO THE SEWING RING. THE DRIVELINE WAS SUBSEQUENTLY TUNNELED AND OUTFLOW GRAFT (OFG) ANASTOMOSIS PERFORMED TO ASCENDING AORTA. WHILE AT 4LPM FROM CPB THE HM3 WAS INITIATED AT 300RPM. SPEED WAS INCREASED TO 4200RPM AND PROVIDED 0.3LPM WHEN A SIGNIFICANT AMOUNT OF AIR IN THE LV WAS OBSERVED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PUMP WAS STOPPED, AND THE PATIENT WAS PLACED BACK ON FULL CPB. DURING INSPECTION FOR THE POSSIBLE AIR SOURCE ON THE LV, THE DOCTOR SAW THAT THE SINTERED TITANIUM OF INFLOW CANNULA WAS VISIBLE ON THE BACKSIDE OF THE PUMP WHEN THE HEART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270139 ↗
• MalfunctionSep 10, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS ADDITIONALLY CONFIRMED THAT THERE WAS CONCERN FOR USE OF EQUIPMENT AFTER BREACH OF STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185868 ↗
• MalfunctionMar 18, 2024Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING IMPLANT THE MINI APICAL CUFF WAS USED AND WHILE ANCHORING THE HEARTMATE 3 PUMP TO THE RING, A DOUBLE CLICK WAS HEARD AND NO YELLOW BARS IN THE PURPLE METAL PART SHOWED. THERE WAS BLEEDING BETWEEN THE PUMP AND THE CUFF. THE PUMP WAS TAKEN OFF THE CUFF AND THE APICAL CUFF HOLDER WAS USED TO TEST HEMOSTASIA IN THE RING. ANY POINT OF BLOOD WAS OBSERVED DURING THE TEST SO THE MINI APICAL CUFF WAS WELL ATTACHED. WHEN THE PUMP WAS ANCHORED TO THE CUFF IT STARTED TO BLEED AGAIN. THE PUMP WAS STARTED TO SEE IF ANY AIR WAS ENTERING BETWEEN THE PUMP AND THE CUFF. THERE WAS NO AIR ENTERING. EVERYTHING WAS DISCONNECTED AND THE PUMP WAS RELOCATED. IT WAS THEN NOTICED THAT WHILE PRESSING THE PUMP TO THE CUFF THERE WAS NO BLEEDING BUT WHEN THE PUMP WAS FREE IN THE CHEST THE BLEEDING RESTARTED. THE PUMP WAS TAKEN OFF THE CUFF AGAIN AND TRIED WITH THE APICAL CUFF FROM THE HEARTMATE 3 KIT. WHEN THE APICAL CUFF WAS ANCHORED IT WAS DISCOVERED THAT THE CUFF COULD MOVE WITHOUT RESTRICTION, SO IT WAS CONCLUDED THAT THE PROBLEM WAS ANCHORING THE PUMP TO THE CUFF AND BACKUP HEARTMATE 3 KIT WAS OPENED. NO BLEEDING OCCURRED ON THE NEW PUMP. REFERENCE REGULATORY REPORT MFR # 2916596

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18925058 ↗
• InjuryJun 30, 2023Device Difficult to Setup or Prepare; No Apparent Adverse Event; Device Difficult to Setup or Prepare; No Apparent Adverse Event

  RELATED MANUFACTURER REPORT NUMBER: 2916596-2023-04721. IT WAS REPORTED THAT DURING THE IMPLANT SURGERY, AFTER THE PUMP WAS LOCKED INTO THE MINI APICAL CUFF, BLEEDING DEVELOPED BETWEEN THE CUFF AND PUMP DURING THE FILLING OF THE HEART. THE PUMP WAS DISCONNECTED, AND THE CUFF HOLDER WAS PUT INTO THE RING. NO FURTHER BLEEDING WAS OBSERVED AND THE SUTURES APPEARED HEMOSTATIC. THE PUMP WAS PLACED BACK INTO PLACE AND THE BLEEDING DECREASED. NO BLEEDING OCCURRED AT THE END OF THE OPERATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241120 ↗
• MalfunctionJan 4, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS LATER REPORTED THAT THE BLEEDING HAD RESOLVED. THE PATIENT WAS STABLE AND PROGRESSING WITH PLANS TO COMPLETE 6 WEEKS OF ANTIPSEUDOMONAL THERAPY FROM SURGERY. RELATED MFR NUMBER FOR THE PUMP EXCHANGE: 2916596-2022-15445. RELATED MFR NUMBER FOR THE NEW PUMP: 2916596-2023-00033.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097117 ↗
• MalfunctionOct 24, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING IMPLANT THE SURGEON USED A BILATERAL THORACOTOMY APPROACH. THE PUMP WAS INITIALLY ATTEMPTED TO LOCK ONTO THE MINI CUFF AS USED IN STANDARD PRACTICE FOR THE SURGEON, BUT HEART TISSUE WAS BELIEVED TO BE GETTING IN THE WAY PREVENTING THE LOCKING MECHANISM. THE TEAM INITIALLY WORKED TO ENSURE NOTHING WAS IN THE CHANNEL OF THE PUMP THAT WOULD BLOCK THE PUMP FROM LOCKING ONTO THE MINI CUFF. ADDITIONAL STICHES WERE PUT AROUND THE MINI CUFF ENSURING NOTHING WAS IMPEDING THE LOCKING MECHANISM, WHILE THE PUMP WAS TAKEN OUT OF THE CHEST AND PLACED IN STERILE INJECTABLE SALINE. THE TEAM ALSO USED THE STERILE REGULAR CUFF AT ONE POINT TO ENSURE THE PUMP LOCKED INTO PLACE WITHOUT DIFFICULTLY. AFTER SOME TIME, THE TEAM ABORTED THE MINI CUFF, REMOVING IT FROM THE APEX OF THE HEART AND REPLACED IT WITH THE REGULAR CUFF. THE PUMP LOCKED ON WITHOUT DIFFICULTY AND THE IMPLANT PROCEEDED. THE PATIENT IS STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662427 ↗
• InjuryAug 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE APICAL CUFF WAS EXPLANTED ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15187111 ↗
• MalfunctionMar 28, 2022Mechanical Problem; Device Difficult to Setup or Prepare; Mechanical Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE SURGEON CONNECTED THE MINI CUFF TO APICAL HOLDER AND NOTED A PLASTIC RING OUT OF PLACE. A NEW HOLDER WOULD BE OBTAINED AND APICAL HOLDER WAS REMOVED. THE PATIENT HAD A STROKE ON (B)(6) 2022 FOLLOWING LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. THERE WERE PUPIL CHANGES BUT NO SIGNS OF STROKE SHOWED ON A COMPUTED TOMOGRAPHY (CT) SCAN. A SUBSEQUENT CT ON (B)(6) 2022 SHOWED DEVELOPMENT OF ISCHEMIC CHANGES IN THE RIGHT FRONTAL LOBE IN THE ANTERIOR ASPECT OF THE MIDDLE CEREBRAL ARTERY (MCA) DISTRIBUTION. THE PATIENT WAS IN THE INTENSIVE CARE UNIT FOR MONITORING AND A NEUROLOGY CONSULT WAS SCHEDULED. THE PATIENTS CARE WAS WITHDRAWN ON (B)(6) 2022 DUE TO NON-RECOVERABLE STROKE. THE PATIENT WAS ON IMPELLA AT P7 BEFORE THE VAD WAS IMPLANTED. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE OPERATED AS INTENDED. RELATED MANUFACTURER REFERENCE REPORT # 2916596-2022-01808.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934281 ↗
• InjuryDec 16, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING IMPLANT, THE SURGEON HAD TO REMOVE THE HEARTMATE 3 (HM3) FROM THE MINI APICAL CUFF AFTER HEMODYNAMIC COMPROMISE AND POOR VENTRICULAR ASSIST DEVICE (VAD) FLOW OCCURRED. TWO ATTEMPTS WERE MADE TO RE-LOCK THE HM3 IN THE MINI APICAL CUFF AFTER THE AREAS AFFECTED BY SURGICAL BLEEDING WERE SUTURED. THE SURGEON THEN PLACED A STITCH AND USED IT TO HELP LEVERAGE THE CUFF TO SECURE; THIS WAS SUCCESSFUL. WHEN THE HM3 RESTARTED, BLEEDING WAS OBSERVED FROM THE BACK OF THE PUMP; IT WAS UNCLEAR WHERE THE BLEED ORIGINATED FROM. THE HM3 WAS REINSERTED INTO THE CUFF, TURNED AND LOCKED SUCCESSFULLY. BLEEDING WAS STILL OBSERVED, BUT IT WAS AN ACCEPTABLE POSTOPERATIVE LEVEL. THE PATIENT WAS TRANSFERRED TO THE ICU AND WAS PROGRESSING WELL. RELATED MANUFACTURER'S REFERENCE #: 2916596-2021-07237.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018250 ↗
• MalfunctionNov 12, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE WHITE PLASTIC APICAL CUFF HOLDER (THE PIECE WHERE THE APICAL CUFF ATTACHES TO THE LONG HANDLE) BROKE WHILE TRYING TO ATTACH THE MINI CUFF TO MYOCARDIUM. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804502 ↗
• MalfunctionJul 23, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE MINI APICAL CUFF WAS OPENED THE CLEAR O-RING WAS DISCOVERED TO BE MISSING. THIS WAS DISCOVERED BY A SCRUB NURSE WHO REMOVED THE HANDLE FROM THE PACKAGE, AND UPON PLACING IT INSIDE THE MINI APICAL CUFF IT CAME RIGHT BACK OUT. THE BOX AND PACKAGE WERE INSPECTED FOR THE MISSING O-RING, HOWEVER IT WAS NOT FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221775 ↗
• InjuryMay 7, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT A MINI CUFF WAS ATTEMPTED TO BE USED WITH THORACOTOMY APPROACH. THE PUMP COULD NOT BE LOCKED ON TO THE SEWING CUFF AFTER MULTIPLE ATTEMPTS. THE DECISION WAS MADE TO REMOVE THE MINI APICAL CUFF AND USE THE TRADITIONAL CUFF. THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) AT TIME OF REPORTED EVENT ON MILRINONE DROPS AT 0.125 MICROGRAMS. THE PATIENT WAS WORKING WITH A PHYSICAL THERAPIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795050 ↗
• MalfunctionJan 27, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2021-00351.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11235747 ↗
• InjuryMay 21, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE IMPLANT WAS STRAIGHTFORWARD. AFTER CORING THE VENTRICLE, THE SURGEON COULD NOT GET THE PUMP TO ENGAGE. THERE WERE 3 TO 4 ATTEMPTS TO ENGAGE. ON THE 4TH ATTEMPT, THE PUMP DID ENGAGE, BUT THEN PULLED OUT. THE PUMP WAS THEN ENGAGED A SECOND TIME BUT THE PUMP PULLED OUT AGAIN. THE PUMP WAS ENGAGED A THIRD TIME WHILE WAITING ON THE VAD ENGINEERING. THERE WERE NO ISSUES AFTER THE THIRD ENGAGEMENT. THE SURGEON STRESSED THAT THEY DID NOT FORCE THE CUFF LOCK AND JUST MADE ADJUSTMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10079965 ↗
• MalfunctionApr 23, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2020-02165. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE SURGEONS HAD DIFFICULTIES TO CONNECT THE PUMP TO THE MINI APICAL CUFF. THE CUFF LOCK OF THE PUMP WAS UNABLE TO BE LOCKED. THE RECOMMENDED SUTURE TECHNIQUE FOR THE MINI APICAL CUFF WAS USED ALTHOUGH A BIT MORE TISSUE WAS VERY CLOSE TO THE CUFF AT LATERAL, APICAL QUADRANT. THE SURGEON TRIED TO CONNECT THE BULKY TISSUE WITH ONE SINGLE ADDITIONAL SUTURE AND AFTERWARDS THE CUFF LOCK WAS STILL NOT LOCKABLE COMPLETELY. DIFFERENT POSITIONS WERE TRIED WHILE CONNECTING THE PUMP ONTO THE CUFF. THE CUFF LOCK SEEMED TO BE CANTED AND THEY HAD TO USE THE UNLOCK TOOL. THE LOCKING MECHANISM WAS HARD TO REOPEN. THE SURGEON DECIDED TO EXCLUDE AN ISSUE WITH THE CUFF LOCK ITSELF AND TESTED IT WITH THE "OLD" APICAL CUFF. THIS WAS SUCCESSFUL. THE REMOVAL OF THE "TEST" CUFF WAS NOT THAT EASY WITH THE UNLOCK TOOL AND AFTERWARDS THE TEAM NOTICED THAT THE LOCKING PART OF THE CUFF LOCK WAS HARDLY WARPED AND NOT USEABLE ANYMORE. DUE TO THIS ISSUE IT WAS DECIDED TO EXCHANGE THE PUMP AND THEY ADDED ONE MORE CORRECTIVE SUTURE TO THE MINI APICAL CUFF. THE CONNECTION OF THE NEW PUMP WAS UNEVENTFUL AND WI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992471 ↗
• MalfunctionDec 27, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT THE APICAL CUFF HOLDER WAS OBSERVED TO BE DAMAGED IN 2 SPOTS, OUT OF THE BOX. THE SURGEON TAPED THE AREAS THAT WERE DAMAGED AND CONTINUED TO USE THE HOLDER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9526094 ↗
• InjuryOct 24, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING IMPLANT THE SURGEON WAS UNABLE TO SUCCESSFULLY LOCK HM3 DEVICE INTO MINI APICAL CUFF EVEN AFTER MULTIPLE ATTEMPTS WERE MADE. SURGEON REMOVED MINI APICAL CUFF AND SUTURED THE ORIGINAL APICAL CUFF FROM THE IMPLANT KIT ONTO THE LEFT VENTRICULAR APEX AND WAS ABLE TO SUCCESSFULLY LOCK THE DEVICE. MINI CUFF REMOVED AND REPLACED WITH ORIGINAL APICAL CUFF, PUMP LOCKED WITHOUT ISSUE. NO FURTHER OR ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235829 ↗
• InjuryJul 25, 2019Difficult to Open or Close; Difficult to Open or Close

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2019. IT WAS REPORTED THAT THERE WAS DIFFICULTY LOCKING DOWN THE PUMP. A FORCEFUL ATTACHMENT WAS MADE BUT THE LOCKING MECHANISM LOCKED INTO PLACE BUT DID NOT ENGAGE AROUND THE MINI APICAL CUFF. THE T TOOL WAS USED TO UNLOCK THE CUFF LOCK. THE MINI APICAL CUFF WAS REMOVED FROM THE APEX AND THE STANDARD CUFF WAS PLACED. THE PUMP LOCKED INTO PLACE WITHOUT DIFFICULTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8825711 ↗
• InjuryMay 15, 2019Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE MINI CUFF USED AND PLACED UTILIZING 12 PLEDGETED SUTURES WAS FAULTY. PROPER SPACING NOTED (WITHIN 1 CM OF CUFF). THE SURGEON HAD DIFFICULTY LOCKING PUMP ONTO CUFF. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO TRIM KNOTS AND REPLACED SOME THAT MAY HAVE BEEN OBSTRUCTING THE CUFF LOCK HOWEVER THE PUMP COULD NOT ATTACH. A DECISION WAS MADE TO REMOVE THE MINI CUFF AND DISPOSE AND USE A REGULAR CUFF. THERE WERE NO ISSUES WITH REGULAR CUFF ENGAGING TO PUMP. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8614273 ↗
• InjuryApr 15, 2019Material Deformation; Material Deformation

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2019. IT WAS REPORTED THAT AFTER SUTURING THE MINI APICAL CUFF, THE MYOCARDIAL TISSUE WAS BULGING TOO MUCH TO ATTACH THE PUMP. THE SURGEON USED 12 SINGLE PLEDGED SUTURES. THE SURGEON DECIDED TO SUTURE THE APICAL CUFF ABOVE THE MINI APICAL CUFF TO AVOID MORE WOUND SURFACE AND POTENTIAL BLEEDING. THE IMPLANT PROCEEDED IN A STRAIGHTFORWARD MANNER AFTER THIS EVENT. THE PATIENT WAS STABLE AND TRANSFERRED TO THE INTENSIVE CARE UNIT. THE EVENT REPORTEDLY ADDED 10 TO 15 MINUTES TO THE IMPLANT SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8515429 ↗
• InjuryMar 11, 2019Connection Problem; Connection Problem

  ADDITIONAL INFORMATION: IT WAS REPORTED THAT INSTEAD OF SUTURING THE CUFF ON PER IFU (INSTRUCTIONS FOR USE) THE SURGEON USED MULTIPLE INTERRUPTED PLEDGETED SUTURES THAT WERE ALSO FARTHER AWAY THAN THE RECOMMENDED DISTANCE FROM THE CUFF. THE SURGEON ALSO USED LARGER FELT SECTIONS ON THE HEART AS WELL AS BIO GLUE. THIS CAUSED SEVERE BUNCHING OF HEART TISSUE AND THE FELT RING PORTION OF THE CUFF TO BUNCH AND GO CONCAVE KEEPING THE PUMP FROM LOCKING ON. ALSO THERE WERE A LOT OF ADDITIONAL KNOTS TAKING UP SPACE ON TOP OF THE FELT AND THESE KNOTS WERE PROBLEMATIC FOR THE LOCKING MECHANISM ON THE PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8408243 ↗
• InjuryFeb 8, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2019. IT WAS REPORTED THAT THE ACCOUNT WAS UNABLE TO LOCK THE HEARTMATE 3 PUMP ONTO THE MINI APICAL CUFF. THE ACCOUNT DID NOT SEE ANY SUTURES BLOCKING THE MECHANISM NOR WAS ANY GLUE USED. THE ACCOUNT ATTEMPTED TO LOCK THE PUMP ONTO THE APICAL CUFF ON THE BACK TABLE, THE LOCKING MECHANISM WORKED FINE. THE ACCOUNT DECIDED TO REPLACE THE MINI APICAL CUFF WITH A STANDARD APICAL CUFF. THE DEVICE WAS SENT BACK FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8320938 ↗

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-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-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; 106531
• 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-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-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

…and 3 more.