HVAD Pump Outflow GraftRecalls & reported problems across all models

We found 3 models of HVAD Pump Outflow Graft by Heartware Inc. in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2017 and Jan 6, 2026 — classified as 5 deaths, 46 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (23 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HVAD Pump Outflow Graft recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 3, 2021Open, Classified

   Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

   Z-2196-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

2. Jun 3, 2021Open, Classified

   Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

   Z-2190-2021 · Root cause: Unknown/Undetermined by firm · names 2 of these models · Recall details · FDA record ↗

Most reported HVAD Pump Outflow Graft problems

HVAD Pump Outflow Graft models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HVAD® Pump Outflow Graft 1125

  Ventricular (Assisst) Bypass
  1 recall5 deaths58 reports
• HVAD® Pump Outflow Graft MCS1725OG

  Ventricular (Assist) Bypass
  1 recall1 report
• HVAD® Pump Outflow Graft 1125

  Ventricular (Assist) Bypass
  1 recall1 report

Recent HVAD Pump Outflow Graft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Deformation Due to Compressive Stress

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED AND REMAINS HOSPITALIZED. THE PATIENT RECEIVED A STENT FOR THE OUTFLOW GRAFT AND WAS SUCCESSFUL. THERE WAS NO DAMAGE TO THE STRAIN RELIEF. THE PHYSICIAN HAS NOT INDICATED ANY CHANGES TO THE PATIENT'S ROUTINE THERAPY.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Swelling/ Edema

  MAUDE report 23977603 ↗
• InjuryNov 5, 2025Obstruction of Flow; Pumping Problem; Obstruction of Flow; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS ADMITTED TO THE HOSPITAL WITH DYSPNEA. THE PATIENT EXPERIENCED SEVERE MITRAL REGURGITATION (MR), MINIMAL-TO-MILD AORTIC REGURGITATION (AR), A LEFT VENTRICULAR (LV) SIZE OF 64/54 MM, AND REDUCED BUT NOT SEVERE RIGHT HEART (RH) FUNCTION. PULMONARY WEDGE PRESSURE (PWP) WAS MEASURED AT 21¿23 MMHG, AND BOTH A RIGHT HEART CATHETERIZATION AND COMPUTED TOMOGRAPHY (CT) SCAN WERE PERFORMED. FIVE LOW-FLOW ALARMS WERE REPORTED, WITH VAD FLOW DECREASING FROM 3 L/MIN TO APPROXIMATELY 2¿2.5 L/MIN. A POSSIBLE GRAFT THROMBOSIS OR OBSTRUCTION WAS SUSPECTED, AS THE PATIENT HAD UNSTABLE INTERNATIONAL NORMALIZED RATIO (INR) LEVELS AFTER INITIATING WARFARIN THERAPY FOLLOWING HVAD IMPLANTATION. RECORDED INR VALUES WERE AS FOLLOWS: (B)(6) 2024: 1.17 / (B)(6) 2024: 1.39 / (B)(6) 2024: 1.75 / (B)(6) 2024: 2.62 / (B)(6) 2024: 1.74 / (B)(6) 2024: 1.24 / (B)(6) 2025: 1.44 / (B)(6) 2025: 1.55 / (B)(6) 2025: 1.31 / (B)(6) 2025: 1.18 / (B)(6) 2025: 1.45 / (B)(6) 2025: 2.11 / (B)(6) 2025: 2.12 / (B)(6) 2025: 2.46. THE PATIENT ALSO FREQUENTLY EXPERIENCED NOSEBLEEDS AND INTERMITTENTLY DISCONTINUED WARFARIN ON THEIR OWN. AN OUTFLOW GRAFT RELEASE SUR

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Epistaxis; Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23477556 ↗
• InjuryJun 24, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE SITE SENT LOGFILES ON THIS PATIENT WITH CONCERNS ABOUT A POSSIBLE CLOT IN THE PATIENT'S OUTFLOW GRAFT. THE LOGFILE REPORT WAS DISCUSSED WITH THE SITE. THE ONLY LAB RESULTS RECEIVED FROM THE SITE DEMONSTRATED A "SLIGHTLY ELEVATED LDH" BUT DID NOT PROVIDE NUMERICAL RESULTS. THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Lactate Dehydrogenase Increased; Thrombosis/Thrombus

  MAUDE report 22318209 ↗
• InjuryOct 21, 2024Obstruction of Flow; Pumping Problem; Obstruction of Flow; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT FELT TIRED, AND THEIR LACTATE DEHYDROGENASE (LDH) WAS 390. SURGICAL INTERVENTION WILL NOT BE PERFORMED FOR NOW. THE PATIENT IS SAID TO BE HEPARINIZED AND BEING MONITORED.

  Patient problems: Fatigue; Heart Failure/Congestive Heart Failure; Lactate Dehydrogenase Increased

  MAUDE report 20500872 ↗
• InjuryFeb 7, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT ON A ROUTINE COMPUTED TOMOGRAPHY (CT) SCAN A KINK IN THE OUTFLOW GRAFT WAS FOUND. THE PATIENT REFUSED SURGICAL INTERVENTION AND IT WAS DECIDED NOT TO STENT. IT WAS NOTED THAT THE OUTFLOW GRAFT WAS WRAPPED IN GORETEX AT THE TIME OF IMPLANT, ESTIMATED FLOWS WERE IN THE 3.0 LPM RANGE WHICH IS NORMAL FOR THIS PATIENT, THE PATIENT WAS SENT HOME WITH MEDICATION. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661275 ↗
• InjuryJul 6, 2023Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE OUTFLOW GRAFT REQUIRED STENTING. THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17266003 ↗
• InjuryJul 13, 2022Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENOSIS OF THE OUTFLOW GRAFT. THE VENTRICULAR ASSIST DEVICE (VAD) WAS EXCHANGED FOR AN UNKNOWN REASON AND THE STATUS OF THE OUTFLOW GRAFT IS UNKNOWN AT THIS TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 15008160 ↗
• InjuryMay 6, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN OUTFLOW GRAFT (OFG) STENT. THE VENTRICULAR ASSIST DEVICE (VAD) OFG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14306899 ↗
• InjuryFeb 24, 2022Obstruction of Flow; Pumping Problem; Obstruction of Flow; Pumping Problem

  IT WAS REPORTED THAT OUTFLOW GRAFT WAS OBSTRUCTED SECONDARY TO EXTRINSIC COMPRESSION AND RELIEF OF THE COMPRESSION WAS PERFORMED. THE OUTFLOW GRAFT REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592789 ↗
• InjuryJan 26, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CONSTITUTIONAL SYMPTOMS. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND DEMONSTRATED STENOSIS AT THE OUTFLOW GRAFT. AN ECHOCARDIOGRAM WAS ALSO PERFORMED AND REVEALED MODERATE AORTIC INSUFFICIENCY, SEVERE TRICUSPID REGURGITATION, AND MODERATE MITRAL VALVE REGURGITATION. THERE WAS A 17 MILLIMETERS OF MERCURY (MMHG) GRADIENT BETWEEN THE OUTFLOW GRAFT AND THE AORTA IDENTIFIED THAT WAS LIKELY AT THE ANASTOMOSIS. MILD PULMONIC VALVE INSUFFICIENCY WAS ALSO NOTED. A STENT WAS DEPLOYED ACROSS THE STENOSIS. PRE-PROCEDURE SIMULTANEOUS PRESSURES WERE MEASURED WITH THE MEAN GRADIENT 32 MMHG, AND REPEAT HEMODYNAMICS AFTER STENTING DEMONSTRATED THE GRADIENT IMPROVED TO 20 MMHG. THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Mitral Valve Insufficiency/ Regurgitation; Pulmonary Valve Insufficiency/ Regurgitation; Stenosis; Tricuspid Valve Insufficiency/ Regurgitation; Unspecified Heart Problem

  MAUDE report 13358736 ↗
• DeathAug 24, 2021Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED OUTFLOW GRAFT STENOSIS. THE OUTFLOW GRAFT STENOSIS WAS TREATED WITH AN ATRIUM COVERED STENT. THE PATIENT SUBSEQUENTLY EXPIRED FROM RIGHT VENTRICULAR FAILURE. NO FURTHER DETAILS WERE REPORTED AS PART OF THE EVENT. THIS EVENT WAS COLLECTED DURING A REVIEW OF PATIENT RECORDS WITH THE HEALTHCARE FACILITY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 12362451 ↗
• InjuryApr 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE VENTRICULAR ASSIST DEVICE (VAD) IMPLANT PROCEDURE, THE OUTFLOW GRAFT (OFG) EXHIBITED LEAKING ASSOCIATED WITH A HOLE OR TINY SLIT IN THE OFG. A SUTURE WAS PLACED, BUT THE LEAK WAS STILL PROFOUND. THE OFG WAS EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668607 ↗
• InjuryJan 5, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR FATIGUE AND DIFFICULTY BREATHING. AN ECHOCARDIOGRAM AND COMPUTERIZED TOMOGRAPHY (CT) SCAN WERE PERFORMED AND SHOWED STENOSIS OF THE OUTFLOW GRAFT. THE PATIENT WAS TAKEN TO THE CATHETERIZATION LAB AND THE OUTFLOW GRAFT WAS STENTED. THE PATIENT WAS BEING WORKED UP FOR TRANSPLANT. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 11120290 ↗
• InjuryNov 11, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SOME MATRIX FILLED THE SPACE BETWEEN THE OUTFLOW GRAFT AND GORE-TEX TUBE OVER A PERIOD OF TIME CAUSING COMPRESSION ON THE OUTFLOW GRAFT. THE GORE-TEX TUBE WAS ORIGINALLY PLACED OVER THE OUTFLOW GRAFT WHEN THE PATIENT WAS IMPLANTED WITH THEIR VENTRICULAR ASSIST DEVICE (VAD). STENTING OF THE OUTFLOW GRAFT WAS PERFORMED AND THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 10825126 ↗
• InjuryOct 26, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE OUTFLOW GRAFT (OFG) EXHIBITED A SUSPECTED OCCLUSION. THE PATIENT WAS HOSPITALIZED AND STENTING OF THE OFG WAS PERFORMED. THE OFG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10734447 ↗

Other Heartware Inc. products

• HVAD Pump Implant Kit5 models · 5,895 reports · 11 recalls
• HeartWare Battery11 models · 4,241 reports · 5 recalls
• HVAD Controller3 models · 2,990 reports · 5 recalls
• HeartWare Controller2 models · 2,393 reports · 3 recalls
• Patient Pack2 models · 224 reports · 2 recalls
• HeartWare Controller AC Adapter5 models · 97 reports · 3 recalls
• HVAD Pump Implant Accessories2 models · 2 reports · 3 recalls
• HeartWare Controller DC Adapter6 models · 59 reports · 1 recall