HVAD® Pump Outflow Graft 1125 (UDI 00888707000222)Recalls & reported problems
Heartware Inc. · Class 3 · Implant
All models of HVAD Pump Outflow Graft (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Heartware HVAD outflow graft is the tube connecting the implanted heart pump to the aorta, and it is implanted surgically. The 58 reports mostly describe the graft becoming blocked, kinked, compressed or narrowed, sometimes with blood clots, blood loss or pump flow problems. Five deaths and 44 injuries are reported. One open recall, started in June 2021, concerns Medtronic halting sales of the HVAD System because comparisons showed more neurological events and deaths than with other heart pumps.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 58
- Deaths reported
- 5
- Injuries reported
- 44
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00888707000222), received between Sep 21, 2017 and Nov 5, 2025 — classified as 5 deaths, 44 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (23 reports).
1 FDA recall record name this device's identifier, 1 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, 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.
Reports received per month
Recalls naming this device
- Jun 3, 2021Class IOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Obstruction of Flow23
- Adverse Event Without Identified Device or Use Problem8
- Deformation Due to Compressive Stress6
- Material Split, Cut or Torn6
- Cut In Material4
- Device Damaged Prior to Use4
- Leak/Splash4
- Pumping Problem4
Patient problems
- No Known Impact Or Consequence To Patient15
- Blood Loss8
- No Clinical Signs, Symptoms or Conditions5
- Dyspnea4
- No Code Available4
- Stenosis4
- Thrombus4
- Cardiac Tamponade3
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST VENTRICULAR ASSIST DEVICE (VAD) IMPLANT, THE PATIENT EXPERIENCED OOZING IN THE GRAFT ANASTOMOSIS SITE, HEMATOMA IN THE MEDIASTINAL SPACE, AND CARDIAC TAMPONADE. THE PATIENT RECEIVED SEVERAL UNITS OF PACKED RED BLOOD CELLS (PRBCS) AND THE HEMATOMA WAS EVACUATED. THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Blood Loss; Cardiac Tamponade
MAUDE report 10362182 ↗InjuryJun 15, 2020Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AS THE OUTFLOW GRAFT HAD A STRICTURE WHICH WAS NOTED VIA COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA). THERE WAS INADEQUATE OR LOW FLOW RATE VIA THE OUTFLOW GRAFT. AN ECHOCARDIOGRAM SHOWED POOR UNLOADING OF THE LEFT VENTRICLE (LV) AND CHEST X-RAY SHOWS PULMONARY EDEMA. A STENT WAS PLACED TO OPEN FLOW TO THE OUTFLOW GRAFT AND THE PATIENT WAS TREATED WITH LASIX INTRAVENOUS (IV). THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pulmonary Edema
MAUDE report 10155566 ↗InjuryMay 22, 2020Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED STENOSIS AT THE ANASTAMOSIS OF THE OUTFLOW GRAFT AND THE PATIENT RECEIVED A STENT. THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10083939 ↗DeathApr 8, 2020Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
AN OUTFLOW GRAFT WAS RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient; Sepsis; Urinary Tract Infection
MAUDE report 9940527 ↗InjuryFeb 17, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT, DURING THE IMPLANT PROCEDURE, THE OUTFLOW GRAFT STRAIN RELIEF WAS UNABLE TO BE SECURED BECAUSE THERE WAS EXCESS OUTFLOW GRAFT ON THE OUTFLOW CANNULA. THE GRAFT WAS PULLED BACK AND THE OUTFLOW GRAFT STRAIN RELIEF WAS SECURED. WHEN THE VENTRICULAR ASSIST DEVICE (VAD) AND OUTFLOW GRAFT WERE IMPLANTED BLOOD APPEARED AND A CUT ON THE OUTFLOW GRAFT WAS IDENTIFIED. THE VAD AND OUTFLOW GRAFT WERE REMOVED AND THE CUT PORTION OF THE OUTFLOW GRAFT WAS REMOVED AND REASSEMBLED. THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Blood Loss
MAUDE report 9716998 ↗InjuryFeb 17, 2020Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARRHYTHMIAS SUSPECTED TO BE CAUSED BY OUTFLOW GRAFT KINKING DUE TO EXCESSIVE LENGTH. COMPUTERIZED TOMOGRAPHY (CT) SHOWED THE OUTFLOW GRAFT CANNULA WAS KINKED. THE PATIENT UNDERWENT REOPERATION TO REMOVE SIX CENTIMETERS FROM THE OUTFLOW GRAFT LENGTH. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. THE OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Ventricular Tachycardia
MAUDE report 9716730 ↗InjuryDec 12, 2019Misassembly by Users; Misassembly by Users
IT WAS REPORTED THAT THE OUTFLOW GRAFT ANASTOMOSIS SITE WAS SEVERELY NARROWED. THE ANASTOMOSIS SITE WAS SUCCESSFULLY STENTED AND THE PATIENT WAS GIVEN ORAL CLOPIDOGREL. THE OUTFLOW GRAFT REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9459712 ↗InjuryNov 27, 2019Misassembly by Users; Misassembly by Users
IT WAS REPORTED THAT THREE DAYS POST VENTRICULAR ASSIST DEVICE (VAD) IMPLANT, THE PATIENT WAS NOTED TO HAVE A LEFT CHEST EFFUSION ON X-RAY. THE PATIENT ALSO HAD INCREASED CENTRAL VENOUS PRESSURE, WORSENING RIGHT VENTRICULAR FUNCTION, AND ELEVATED PULMONARY ARTERY PRESSURE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR EXPLORATION. APPROXIMATELY 300 MILLILITERS OF BLOOD WAS REMOVED AND IT WAS FOUND THAT THE OUTFLOW GRAFT (OFG) ANASTOMOSIS SITE WAS LEAKING. ADDITIONAL SUTURES WERE PUT IN PLACE TO REINFORCE THE ANASTOMOSIS WITH THE ASCENDING AORTA. THE OFG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Blood Loss; Pleural Effusion
MAUDE report 9385618 ↗InjuryNov 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT SHORTLY AFTER IMPLANT THE PATIENT EXPERIENCED SYMPTOMS OF TAMPONADE AND HAD TO RETURN TO THE OPERATING ROOM (OR). ON THE SAME DAY, THE PATIENT SHOWED SIGNS OF BLEEDING. UPON REVISITING THE OPERATING ROOM, IT WAS NOTED THAT THERE WAS A CRACK/SMALL HOLE IN THE OUTFLOW GRAFT, CLOSE TO THE PUMP. THE OUTFLOW GRAFT WAS SHORTENED AND THE PATIENT WAS CLOSED UP. THE PATIENT BEGAN EXHIBITING SIGNS OF BLEEDING THE NEXT DAY. THEREFORE, THE OUTFLOW GRAFT WAS EXPLANTED AND EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Blood Loss; Cardiac Tamponade
MAUDE report 9296864 ↗MalfunctionNov 5, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT PRIOR TO THE VENTRICULAR ASSIST DEVICE (VAD) IMPLANT, THERE WAS A SIGNIFICANT AMOUNT OF SALINE OOZING OR LEAKING AROUND THE CLAMP CONNECTION TO THE VAD THROUGH THE OUTFLOW GRAFT. THE OUTFLOW GRAFT WAS REMOVED FROM THE ASSEMBLY AND ANALYZED. NO TEARS OR HOLES WERE NOTED. THE GRAFT WAS THEN FLIPPED AND THE OPPOSITE END WAS ATTACHED TO THE VAD ASSEMBLY. AGAIN, A SIGNIFICANT AMOUNT OF SALINE WAS NOTED TO BE OOZING. THE OUTFLOW GRAFT WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9279250 ↗MalfunctionOct 24, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING THE DE-AIRING PORTION OF THE VENTRICULAR ASSIST DEVICE (VAD) IMPLANT PROCEDURE A TEAR IN THE OUTFLOW GRAFT WAS DISCOVERED. OUTFLOW GRAFT WITH THE TEAR WAS REMOVED AND RE-ATTACHED TO THE VAD WITH NO ISSUES. THE OUTFLOW GRAFT REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9233414 ↗InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER VENTRICULAR ASSIST DEVICE (VAD) IMPLANT, THE PATIENT'S SEDATION WAS LIFTED BUT THE PATIENT WOULD NOT RESPOND TO STIMULI. A HEAD COMPUTERIZED TOMOGRAPHY (CT) SHOWED AN EMBOLIC STOKE. IT WAS NOTED DURING IMPLANT THAT THERE WAS HARD PLAQUE IN THE ASCENDING AND AORTIC ROOT. IT WAS SUSPECTED THAT DURING IMPLANT AND ANASTOMOSIS OF THE OUTFLOW GRAFT, SOME OF THE PLAQUE HAD BROKEN OFF AND CAUSED THE STROKE. NO RESIDUAL DEFICITS FROM THE STROKE WERE NOTED. THE PATIENT REMAINS IN THE INTENSIVE CARE UNIT (ICU) AND IS AWAKE AND RESPONSIVE. THE VAD OUTFLOW GRAFT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Stroke/CVA
MAUDE report 9132155 ↗
Other Ventricular (Assisst) Bypass devices
- Thoratec® HeartMate 3™ 106524USThoratec Corporation · Ventricular (Assisst) Bypass7 recalls5,096 deaths16,478 reports
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015Thoratec Corporation · Ventricular (Assisst) Bypass2 recalls2,141 deaths8,000 reports
- Thoratec® HeartMate 3™ 106531USThoratec Corporation · Ventricular (Assisst) Bypass1 recall11 deaths4,646 reports
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit (Enhanced) 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls573 deaths2,807 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HEARTMATE®, MOBILE POWER UNIT, NA 107754Thoratec Corporation · Ventricular (Assisst) Bypass1 death2,098 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page