CentriMag™ 102953Recalls & reported problems

Summary

The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 07640135140627), received between Nov 20, 2018 and Sep 10, 2026 — classified as 35 deaths, 125 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (34 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 10, 2025Open, Classified

   Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

   Z-1099-2026 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 209 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721469 ↗
• MalfunctionAug 17, 2026Mechanical Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50281500 ↗
• DeathAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the research article: "Comparison of Outcomes in Patients Requiring Mechanical Circulatory Support Who Received Cangrelor in Addition to Anticoagulation Versus Anticoagulation Alone" that CentriMag may be associated with major bleeding, thrombosis, stroke, and death. This study evaluated safety of cangrelor administered concurrently with heparin or bivalirudin in patients implanted with mechanical circulatory support (MCS) consecutively admitted between 01Jan2016 and 20Oct2020. The primary outcome of the study was major bleeding, defined as clinically overt bleeding associated with hemoglobin fall >= 2 g/dL within 24-hours, > 20 mL/kg measurable blood loss within 24 hours, >= 10 mL/kg pack RBC transfusions within 24 hours; retroperitoneal bleeding, pulmonary bleeding, bleeding involving the central nervous system, or bleeding requiring surgical intervention. Secondary outcomes included major bleeding based on antithrombotic modality (single-, double-, or triple-antithrombotic therapy), incidence of stent thrombosis (ST), thrombotic events including deep vein thrombosis, pulmonary embolism, embolic stroke, extracorporeal membrane oxygenation (ECMO) or oxygena

  Patient problems: Insufficient Information

  MAUDE report 50223066 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was a Motor failure on therapy. The CentriMag Pump was switched to backup Motor and Console. A "Flow below minimum" Alarm occurred while the patient's vital signs were deteriorating. Troubleshooting efforts included attempts to both increase and decrease the CentriMag RPMs; however, the 'Flow below minimum' alarm continued to recur. Flow could not be achieved, and the reported Flow decreased to 0.00 despite the CentriMag continuing to run at approximately 2450 RPM. The Pump was subsequently transferred to a backup Motor and Console. Following the exchange, Flow did not immediately normalize; however, approximately two minutes later, Flow returned after patient-focused interventions, including volume administration, repositioning, and sedation, were implemented.

  Patient problems: Insufficient Information

  MAUDE report 50074190 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CENTRIMAG PATIENT EXPERIENCED A LIFE THREATENING ISCHEMIC STROKE.

  Patient problems: Ischemia Stroke

  MAUDE report 24707362 ↗
• MalfunctionMar 5, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PUMP WAS NOT SEATED PROPERLY IN THE MOTOR. THEY MOVED THE PUMP TO BACKUP MOTOR AND RESUMED SUPPORT. THE EVENT WAS RESOLVED BY SWITCHING THE PUMP TO A BACKUP MOTOR. NO PRODUCTS WERE EXCHANGED AND NO PRODUCTS ARE RETURNING TO ABBOTT. THE PUMP WORKED AS INTENDED ON THE PATIENT ONCE SEATED IN THE NEW PUMP AND IS STILL ACTIVE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520812 ↗
• MalfunctionMar 2, 2026Device Difficult to Setup or Prepare; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CENTRIMAG MOTOR SCREW WAS NOT LOCKING AND SECURING THE BLOOD PUMP. THE PUMP WAS COLLECTED FOR ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492389 ↗
• MalfunctionMar 2, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PLACED ON RIGHT VENTRICULAR ASSIST DEVICE (RVAD) RELATED TO RIGHT VENTRICULAR (RV) DYSFUNCTION ON POST OPERATIVE DAY 2. ON (B)(6) 2026 THE PATIENT WAS RETURNING FOR POSSIBLE PUMP EXCHANGE RELATED TO HAVING CLOTTING ISSUES WITH RVAD WHICH IS CENTRIMAG. THE PATIENT WAS GETTING TURNED TO CLEAN. THE PATIENT COMPLAINS OF CHEST PAIN AND HAD LOW FLOW ON HEARTMATE 3 AND ECMO. THE PATIENT RETURNED TO SUPINE POSITION. THEY NOTED HEMORRHAGE FROM PREVIOUS CHEST TUBE SITE AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED; PATIENT PLACED IN TRENDELENBURG POSITION. MASS TRANSFUSION PROTOCOL WAS INITIATED. ECMO WAS CLAMPED DUE TO CAVITATION. IT APPEARED THAT THE LOG FILE CAPTURED LOW FLOW EVENTS ON 08FEB2026. IT WAS REPORTED THAT THE PATIENT HAD RIGHT VENTRICULAR DYSFUNCTION PRE-LVAD IMPLANT AS THERE WAS RVAD DURING LVAD IMPLANT. THE CAUSE OF RIGHT VENTRICULAR DYSFUNCTION WAS NOT DEVICE RELATED. THEY ALSO NOTED PROTEK PERFORATED PULMONARY ARTERY (PA). THE CAUSE OF LOW FLOW WAS DUE TO VOLUME DEPLETED AND THEY DID MASS TRANSFUSION.

  Patient problems: Air Embolism; Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 24490892 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE CHEST WAS CLOSED, THE ARTERIAL PRESSURE DROPPED SIGNIFICANTLY DUE TO VASOPLEGIA. THE HEARTMATE 3 INCREASED FLOW AND THE RIGHT VENTRICLE ENLARGED WHICH CAUSED A LOT OF HARM. THE PATIENT MORE OR LESS RECOVERED WITH A LOT OF DRUGS. A RIGHT VENTRICULAR ASSIST DEVICE (RVAD) WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS PLACED WITH PROTEK DUO DUE TO RIGHT HEART FAILURE. THE RVAD WAS A CENTRIMAG PUMP. THE LUNGS OF THE PATIENT WERE DAMAGED, AND THEY DID NOT SATURATE WELL. THE PATIENT HAD RIGHT HEART FAILURE, BLEEDING AT THE OUTFLOW GRAFT OF THE HEARTMATE 3, HYPOVOLEMIC SHOCK, CARDIAC COLLAPSE, AND VASOPLEGIA. THE PATIENT WAS TREATED BY REOPENING THE CHEST, ECHOCARDIOGRAM, AND MONITORING HEMODYNAMIC PARAMETERS. THE PATIENT PASSED AWAY. THE OUTCOME WAS NOT CONSIDERED DEVICE OR THERAPY RELATED AND THE DEVICE OPERATED AS EXPECTED. AN AUTOPSY WAS NOT PERFORMED, AND THE DEVICE WAS NOT EXPLANTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 24462328 ↗
• MalfunctionJan 22, 2026Device Difficult to Setup or Prepare; Infusion or Flow Problem

  IT WAS REPORTED THAT WHILE THE PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), THE PUMP CONTINUALLY TRIGGERED FLOW BELOW MINIMAL LEVEL ALARM. THERE WAS NO CHANGE IN FLOW ON THE SCREEN OR THE RED FLOW INDICATOR BAR. THE ONLY NOTICEABLE CHANGE WAS WHAT LOOKED LIKE A SLIGHT SUCTION EVENT ON THE LINEAR TRACE ON SCREEN. ONCE OFF OF ECMO AND CLAMPED OFF TO THE PATIENT, CIRCULATING THROUGH THE ARTERIAL VENOUS BRIDGE, THE LOW FLOW AS WELL AS THE MAXIMUM FLOW ALARM CONTINUED TO ALARM, WITH NO NOTICEABLE CHANGE ON SCREEN. THE PATIENT WAS ISOLATED FROM THE CIRCUIT AND FLOW THROUGH THE BRIDGE WAS APPROXIMATELY 300ML/MIN. THERE WERE SLIGHT CONCERNS OF A POSSIBLE ISSUE WITH EQUIPMENT AS THE HEALTHCARE PROVIDER COULD VISIBLY WATCH THE ALARM TRIGGER EVERY 10 MINUTES WITH NO CHANGE IN FLOW OR PRESSURE ON SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148368 ↗
• DeathDec 29, 2025Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) SUPPORT AND WAS UNSTABLE DUE TO BLEEDING SECONDARY TO COMPLICATIONS FOLLOWING A C-SECTION. THE PATIENT WAS PLACED ON ECMO DURING THE NIGHT SHIFT AND A S3 ALARM APPEARED, ALONG WITH A FLOW INTERRUPTED ALARM. BOTH ALARMS WERE UNABLE TO BE CLEARED. DUE TO THE PATIENT'S INSTABILITY, THEY WERE NOT SWITCHED TO THE BACKUP SYSTEM. THE TEAM TURNED ON THE BACKUP SYSTEM SO THEY WERE ABLE TO MEASURE FLOWS ON THE BACKUP CONSOLE TO ENSURE THEY WERE ACHIEVING THE HIGHEST FLOWS POSSIBLE GIVEN THE PATIENT'S CONDITION. THE PATIENT EXPIRED DURING THE DAY SHIFT, WHICH WAS REPORTED TO HAVE BEEN UNRELATED TO THE ALARMS ON THE CENTRIMAG. THE PATIENT OUTCOME WAS RELATED TO THE UNCONTROLLED BLEEDING AND IRRECOVERABLE ORGAN FAILURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Multiple Organ Dysfunction Syndrome

  MAUDE report 23913955 ↗
• InjuryDec 23, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  THE PUMP MOTOR SPEED (RPM) WAS UNKNOWN.

  Patient problems: Embolism/Embolus

  MAUDE report 23881927 ↗
• MalfunctionDec 15, 2025Device Difficult to Setup or Prepare; No Apparent Adverse Event; Device Difficult to Setup or Prepare; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER TRIED TO INITIATE A USE OF CENTRIMAG MOTOR AND CONSOLE. DURING START UP, AN M3, PUMP NOT INSERTED, ALARM WAS OBSERVED. THE MOTOR WAS SWAPPED OUT WITH A REPLACEMENT AND THE SYSTEM WORKED AS EXPECTED. IT WAS NOTED THAT THE CONSOLE CONTINUED TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812494 ↗
• DeathDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ISCHEMIA OF THE LEFT FOOT THAT REQUIRED MEDICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY.

  Patient problems: Insufficient Information; Ischemia

  MAUDE report 23721521 ↗
• InjuryNov 13, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE FLOW HAD TO BE SET "QUITE HIGH" IN ORDER TO GET IT TO FLOW AT ALL, THEN COME BACK DOWN A BIT. A FEW HOURS LATER IN CARDIOVASCULAR, FLOWS WERE LOST AGAIN AND HAD TO SWITCH TO ANOTHER CIRCUIT. THERE WAS SOME CLOTTING IN THE VENOUS CANNULA. IT WAS NOTED THERE WAS ALSO A CORRELATION BETWEEN HEMODYNAMICS AND THE EVENT. THE CENTRIMAG CONSOLE WAS EXCHANGED.

  Patient problems: Hemodynamic instability; Thrombosis/Thrombus

  MAUDE report 23547846 ↗
• InjuryNov 4, 2025Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  IT WAS REPORTED THROUGH MEDWATCH REPORT # MW5176465 THAT THE ASSISTANT MECHANICAL CIRCULATORY SUPPORT (MCS) COORDINATOR REPORTED A NEW SQUEAKING SOUND COMING FROM THE CENTRIFUGAL PUMP (CP). THEY SENT A SHORT CLIP OF THE CENTRIFUGAL PUMP WITH THE HIGH-PITCHED NOISE. THEY ALSO SENT A PICTURE OF THE GALLERY VIEW WITH THE PATIENT PARAMETERS SHOWN. THE CLINICAL SPECIALIST CALLED FOR THE DETAILS. THERE WERE SOME CHANGES IN PATIENT PARAMETERS, WHICH SUGGESTED A CIRCUIT CHANGE OUT WAS NEEDED. THEY CHANGED THE CIRCUIT TO A CENTRIMAG PUMP. THEY ALMOST DISCOVERED A CLOT IN THE CIRCUIT AND SENT A PHOTO OF IT. THE PATIENT PARAMETERS ON THE CENTRIMAG SCREEN SEEMED TO HAVE BEEN NORMAL FOR THE TIME BEING. A BIOHAZARD KIT WAS DELIVERED. IT WAS REPORTED THAT THE SAME PATIENT DEVELOPED A CLOT WHILE ON THE PREVIOUS CIRCUIT WITH ROTOFLOW BEFORE SWITCHING TO VITALFLOW.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23469205 ↗
• InjuryNov 4, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT WAS PLACED ON CENTRIMAG SUPPORT IN THE CATHETERIZATION LABORATORY. UPON INITIATION, A MASSIVE BLOOD TRANSFUSION WAS STARTED. CLOT FORMATION OCCURRED WITHIN THE CIRCUIT, RESULTING IN A LOW FLOW ALARM. THE PERFUSIONIST OBSERVED CESSATION OF FLOW AND REPLACED THE CIRCUIT. THE ORIGINAL CIRCUIT HAD CLOTTED OFF. THE MANAGER REQUESTED AN EXPLANT KIT FOR THE MOTOR AND CONSOLE TO BE TESTED FOR SAFETY EVALUATION. THE CANNULAS WERE FLUSHED BY THE SURGEON; HOWEVER, NO FLOW WAS OBSERVED, SO THE CIRCUIT CHANGE.

  Patient problems: Insufficient Information

  MAUDE report 23466755 ↗
• DeathOct 15, 2025Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT WAS ON CENTRIMAG (CMAG) MECHANICAL CIRCULATORY SUPPORT WHEN THE CONSOLE STOPPED WORKING. THE CUSTOMER SWAPPED OUT THE CMAG CONSOLE, MOTOR, AND MONITOR FOR A NEW SET AND THE CUSTOMER WAS PLACED BACK ON SUPPORT. IT WAS COMMUNICATED ON (B)(6)2025 THAT THE PATIENT PASSED AWAY. IT WAS POSSIBLE THAT THE DEVICE ISSUE IMPACTED THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23295947 ↗
• InjurySep 8, 2025Pumping Stopped; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown; Pumping Stopped; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown

  IT WAS REPORTED THAT A PATIENT ON SUPPORT WITH THE CENTRIMAG WENT INTO VENTRICULAR FIBRILLATION. THE ONLY SYMPTOM OF ARRHYTHMIA THE PATIENT EXPERIENCED WAS HYPOTENSION SINCE THE PATIENT WAS INTUBATED AND SEDATED AT THE TIME. THE PERFUSIONIST STATED THAT THE REVALUATIONS PER MINUTE (RPMS) DECREASED TO ZERO AND FLOW DECREASED WITHOUT USER ADJUSTMENT AFTER THE ARRHYTHMIA OCCURRED. THE PUMP TRANSFERRED TO ANOTHER MOTOR AND TAKEN OUT OF SERVICE. IT WAS NOTED THAT THERE WAS A RED ALARM ASSOCIATED WITH THE EVENT. THE PATIENT'S ARRHYTHMIA RESOLVED BY ITSELF WITHOUT INTERVENTION. THE TYPE OF ARRYTHMIA WAS LATER DETERMINED TO BE VENTRICULAR TACHYCARDIA, AND WAS NOT SUSTAINED. THE PATIENT DID NOT HAVE A HISTORY OF ARRHYTHMIA PRIOR TO CENTRIMAG SUPPORT, BUT THE ARRHYTHMIA WAS NOT THOUGHT TO BE DEVICE RELATED. THE PATIENT WAS NOTED TO STILL BE ADMITTED AS OF (B)(6) 2025. THE CAUSE OF THE 0 RPMS WAS NOT KNOWN.

  Patient problems: Low Blood Pressure/ Hypotension; Tachycardia; Ventricular Fibrillation

  MAUDE report 22998571 ↗
• DeathAug 29, 2025Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown

  ON (B)(6) 2025, THE PATIENT PASSED AWAY DUE TO HEMORRHAGING AND THE FAMILY STOPPING CARE. IT WAS THOUGHT THE PATIENT DEATH WAS NOT DEVICE RELATED.

  Patient problems: Hemodynamic instability; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 22927046 ↗
• MalfunctionAug 12, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THERE WAS A GRINDING NOISE THAT CAME FROM THE CENTRIMAG MOTOR. THERE WAS A DELAY TO START THE PUMP DUE TO THE MOTOR ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787210 ↗
• MalfunctionJul 16, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT ONE OF THE CENTRIMAG PUMP MOTORS WAS MAKING A LOUD NOISE WHILE RUNNING. THIS WAS NOTICED WHILE DOING DAILY CHECKS. THIS WAS NOT BEING USED ON A PATIENT. THE NURSE MOVED THE EQUIPMENT TO BIOMED AND THEY CALLED THE ABBOTT SERVICE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520763 ↗
• DeathJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS PUMP INFLOW OCCLUSION (PROTEIN LIKE MATERIAL) [MANUFACTURER REPORT #2916596-2024-05753]. THE PATIENT PRESENTED WITH SIMILAR SYMPTOMS BUT NO DECREMENT IN FLOW. LOG FILES WERE SENT FOR REVIEW. THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT APPEARED TO HAVE OPERATED AS INTENDED. IT WAS REQUESTED TO HAVE LOW FLOW ALARM THRESHOLD CHANGED TO 2.0 LITERS PER MINUTE (LPM) ON THE PATIENT'S PRIMARY SYSTEM CONTROLLER. DUE TO THE PATIENT'S HIGH ACUITY ON CARDIOHELP EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), IT WAS REQUESTED THAT THE THRESHOLD BE LOWERED WITHOUT HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) SUPPORT INTERRUPTION. SINCE THE LAST DOWNLOAD, THE PATIENT HAD BEEN PLACED ON ECMO FOR SUPPORT AND SPEED WAS INCREASED TO 6400. AN ECHOCARDIOGRAM SHOWED LEFT VENTRICULAR END-DIASTOLIC DIAMETER (LVEDD) AT 6.6 CM, UP FROM 4. N-TERMINAL PRO-B-TYPE NATRIURETIC PEPTIDE (NT-PROBNP) WAS AT BASELINE 500 AND SPEED WAS AT 6600 REVOLUTIONS PER MINUTE (RPM). ADDITIONAL LOG FILES WERE SENT FOR REVIEW. THE LOG FILE CAPTURED THE FLOW BETWEEN 4.0-5.3 LPM. THERE WERE NO LOW FLOW EVENTS

  Patient problems: Air Embolism; Convulsion/Seizure; Multiple Organ Dysfunction Syndrome

  MAUDE report 22511552 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND HAD A HISTORY OF RECENT MITRAL VALVE REPLACEMENT (MVR), STENTS, AND THROMBUS ON THE MITRAL VALVE (MV) PRE-IMPLANT. A CENTRIMAG RIGHT VENTRICULAR ASSIST DEVICE (RVAD) VIA A THIRD-PARTY CATHETER (PROTEK DUO) WAS PLACED DUE TO RIGHT VENTRICULAR (RV) DYSFUNCTION. ON (B)(6) 2025, THE PATIENT PASSED AWAY DUE TO A LARGE MID-CEREBRAL ARTERY (MCA) STROKE.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhagic Stroke; Ischemia Stroke; Stroke/CVA

  MAUDE report 22482855 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A CENTRIMAG POST LEFT VENTRICULAR ASSIST DEVICE (LVAD) PLACEMENT. THE PATIENT WAS IMPLANTED WITH THE LVAD ON (B)(6) 2024. IT WAS REPORTED THAT THE LVAD WAS FUNCTIONING AS INTENDED AND THAT THE CENTRIMAG WAS PLACED DUE TO ACUTE POST-OPERATIVE RIGHT HEART FAILURE (RHF) WITH VASOPLEGIA. IT WAS NOTED THAT THE PATIENT HAD MILD-MODERATELY REDUCED RV FUNCTION PRIOR TO IMPLANT SEEN IN A PREVAD ECHOCARDIOGRAM (ECHO). THE DAY BEFORE THE PATIENT HAD AN IMPELLA RP FLEX INSERTED WITH A SLIGHT INCREASE ON FLOWS. IT WAS DECIDED TO TRANSITION THE PATIENT TO A CENTRIMAG ON (B)(6) 2024. AFTER UPGRADE TO RVAD CENTRIMAG SUPPORT THE PATIENTS, LOW FLOWS IMPROVED. IT WAS NOTED THAT THE PATIENT WAS STABLE. THERE WERE NO DEVICE RELATED ISSUES. THE DEVICE WAS NOT THOUGH TO HAVE CONTRIBUTED TO THE RIGHT HEART FAILURE. LOG FILES WERE UNAVAILABLE. THE PATIENT DEVELOPED MULTIFOCAL PNEUMONIA REQUIRING REINTUBATION ON (B)(6) 2024. THE PATIENT ALSO EXPERIENCED VENTRICULAR FIBRILLATION WITH 1 SHOCK ON (B)(6) 2024. THE FAMILY OF THE PATIENT DID NOT FEEL ONGOING CARE WAS CONSISTENT WITH PATIENTS WISHES AND DEVICE SUPPORT WAS DISCONTINUED ON (B)(6) 2024. THE PATIENT PASSED AWA

  Patient problems: Ventricular Fibrillation

  MAUDE report 22481739 ↗