Impella Impella 5.0 AIC Pump SetRecalls & reported problems

Summary

The FDA's MAUDE database contains 256 adverse event reports that list this exact device (DI 00813502011180), received between Feb 29, 2016 and Jan 7, 2026 — classified as 56 deaths, 126 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (58 reports).

3 FDA recall records name this device's identifier, 3 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.

Recalls naming this device

1. Dec 27, 2023Class IOpen, Classified

   IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

   Z-0980-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Dec 27, 2023Class IIOpen, Classified

   New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

   Z-1074-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

3. Jun 14, 2023Class IOpen, Classified

   There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.

   Z-2112-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 256 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Malposition of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE USER FACILITY REPORTED A 50 YEAR OLD MALE PATIENT WHO EXPERIENCED OOZING AROUND THE SHEATH AFTER PEEL-AWAY SHEATH REMOVAL. OOZING CONTINUED AFTER TRANSFER TO THE INTENSIVE CARE UNIT. MANUAL PRESSURE WAS APPLIED, AND THE SHEATH WAS SECURED WITH EXTRA GAUZE TO MAINTAIN FORWARD TENSION AND ANGLE ALIGNMENT. THE PATIENT¿S ABDOMEN WAS TAPED TO REDUCE PRESSURE ON THE SHEATH. ACT WAS 255 AT THE TIME. THE CARDIOLOGIST, INTERVENTIONALIST, AND INTENSIVIST WERE NOTIFIED AND DID NOT EXPRESS CONCERN. THE INTRODUCER KIT WAS DISCARDED, AND THE PATIENT REMAINED ON DEVICE SUPPORT WITH FLOWS AND HEMODYNAMICS WITHIN NORMAL LIMITS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemolysis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23999938 ↗
• MalfunctionDec 13, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED THAT A PATIENT IN POST CARDIOTOMY CARDIOGENIC SHOCK AND WITH LOW CARDIAC OUTPUT SYNDROME WAS BEING IMPLANTED WITH AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THE IMPELLA 5.0 WAS UNABLE TO BE INSERTED. ACCORDING TO THE PHYSICIANS THE PATIENT'S VESSEL SIZE WAS TOO SMALL FOR THE 5.0 TO ADVANCE. AN IMPELLA CP WAS USED INSTEAD AND THE CASE CONTINUED AS PLANNED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931946 ↗
• MalfunctionDec 13, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED THAT A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS BEING IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE IMPELLA 5.0 WAS UNABLE TO BE INSERTED THROUGH THE SUBCLAVIAN ARTERY. THE VESSEL WAS MEASURED UPON INITIAL CUTDOWN AND WAS FOUND TO BE 8MM, SO THE 5.0 INSERTION WAS ATTEMPTED. THE PHYSICIAN FELT RESISTANCE AND SUSPECTED STENOSIS SO IT WAS DECIDED TO PLACE A CP INSTEAD. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931859 ↗
• MalfunctionDec 13, 2024Increase in Pressure; Increase in Pressure

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE CLINICAL TEAM REPORTED THAT RECURRENT "HIGH PURGE PRESSURE" ALARMS WITH LOW PURGE FLOW OCCURRED DURING IMPELLA SUPPORT. ATTEMPTING TO TROUBLESHOOT THE ISSUE, THE TEAM DECREASED THE PUMP SPEED TO P-0 AND THEN IMMEDIATELY RETURNED IT TO P-7, WHICH SUCCESSFULLY IMPROVED THE PURGE FLOW. HOWEVER, THE PURGE FLOW RATE TRENDED DOWNWARDS OVER THE NEXT 24 HOURS, WHICH LED TO THE USE OF THE SAME INTERVENTION AGAIN. IT WAS NOTED THAT THE PURGE FLOW NEVER EXCEEDED 5 ML/HR THROUGHOUT SUPPORT. ACTIVATED CLOTTING TIME (ACT) WAS ASSERTED TO BE IN NORMAL THERAPEUTIC RANGE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931303 ↗
• MalfunctionDec 13, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT WAS BEING IMPLANTED WITH A NEW IMPELLA 5.0 IN THE AXILLARY ARTERY FOR LONGER SUPPORT AND AMBULATION. THE PATIENT HAD AN EXISTING IMPELLA CP THAT HAD BEEN PLACED IN THE RIGHT FEMORAL ARTERY. IT WAS REPORTED THAT THE IMPELLA 5.0 WAS NOT ABLE TO BE ADVANCED PAST THE DISTAL INNOMINATE (BRACHIOCEPHALIC) ARTERY DUE TO PATIENT ANATOMY. IMPELLA 5.0 WAS COATED IN A LUBRICANT (VIPERSLIDE) AND REINSERTED AGAIN UNSUCCESSFULLY. THE DECISION WAS MADE TO ABORT THE 5.0 INSERTION AND INSERT AN IMPELLA CP INSTEAD. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931126 ↗
• MalfunctionDec 13, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE SITE REPORTED THAT IMPELLA 5.0 WOULD NOT MAKE THE TURN INTO THE AORTA FROM THE SUBCLAVIAN ARTERY DURING INSERTION. THE CANNULA REPORTEDLY KEPT COLLAPSING WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE. THE PHYSICIAN STATED THAT THE PATIENT¿S VESSEL WAS TOO SMALL. INSERTION WAS ABORTED AND AN IMPELLA CP WAS PLACED INSTEAD. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930066 ↗
• MalfunctionDec 13, 2024Failure to Advance; Failure to Advance

  THE COMPLAINANT REPORTED THAT A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS BEING IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DELIVER THE IMPELLA 5.0 MULTIPLE TIMES BUT WAS UNABLE TO CROSS INTO THE AORTA. THE DECISION WAS MADE TO MOVE FORWARD WITH AN IMPELLA CP INSTEAD WHICH WAS DELIVERED WITH NO ISSUES. ADDITIONAL INFORMATION INDICATED THAT NOTHING REMARKABLE WAS NOTED REGARDING THE PATIENT¿S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929624 ↗
• DeathDec 13, 2024Increase in Pressure; Increase in Pressure

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL FOR RESPIRATORY FAILURE WITH EKG CHANGES. THE PATIENT WAS INITIALLY IMPLANTED WITH AN IMPELLA CP BUT WAS LATER THEN ESCALATED TO AN IMPELLA 5.0. IT WAS REPORTED WHILE ON IMPELLA 5.0 SUPPORT, THE PATIENT EXPERIENCED EPISODES OF VENTRICULAR TACHYCARDIA ON (B)(6) 2021 THAT WAS RESOLVED WITH DEFIBRILLATION ON TWO OCCASIONS. THE PATIENT ALSO HAD SPUTUM CULTURES THAT DAY THAT WERE POSITIVE FOR GRAM POSITIVE COCCI AND RODS WITH AN ELEVATED WHITE BLOOD COUNT OF 15,000 CELLS/UL. THE RELATIONSHIP OF THE INFECTION TO THE IMPELLA IS UNLIKELY, HOWEVER THE CAUSE OF THE INFECTION WAS UNKNOWN OR NOT REPORTED. IT WAS NOTED THAT THERE WERE NO IMPELLA CONCERNS. THE PATIENT WAS MOVED TO THE COVID UNIT THE SAME DAY, ON (B)(6) 2021. IT WAS REPORTED THE NIGHT ON (B)(6) 2021 THE PUMP HAD ALARMS FOR HIGH PURGE PRESSURE AND LOW PURGE FLOW. THE MEDICAL TEAM PERFORMED THE TISSUE PLASMINOGEN ACTIVATOR LYSIS PROTOCOL TO RESOLVE THE ISSUE. THE FOLLOWING DAY ON (B)(6) 2021, THE PATIENT EXPERIENCED TWO MORE EPI

  Patient problems: Sepsis; Tachycardia

  MAUDE report 20929536 ↗
• DeathNov 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT WITH CARDIOMYOPATHY WAS ON AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS, IT WAS NOTED THAT THE PLAN WAS TO LET THE PATIENT REST AND TREAT THE SEPSIS. THE TYPE OF TREATMENT IS UNKNOWN. ADDITIONAL INFORMATION NOTED THE PATIENT WAS MADE A DO NOT RESUSCITATE, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THE RELATIONSHIP BETWEEN THE IMPELLA 5.0 AND THE PATIENT'S DIAGNOSIS OF SEPSIS IS UNKNOWN, HOWEVER THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Sepsis

  MAUDE report 20813854 ↗
• DeathNov 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK / LOW CARDIAC OUTPUT SYNDROME WAS GOING TO BE ON AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE IMPELLA 5.0 WAS UNABLE TO BE FULLY UTILIZED, THE PATIENT'S AXILLARY WAS TOO SMALL FOR THE DELIVERY OF THE 5.0 DEVICE. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE AND REPLACE IT WITH AN IMPELLA CP. THE EXCHANGE RESULTED IN LOSS OF MECHANICAL CIRCULATORY SUPPORT TO THE PATIENT AT A CRITICAL TIME. THE PATIENT EXPIRED THE NEXT DAY; CARE WAS WITHDRAWN. ALTHOUGH MORE LIKELY THE PATIENT EXPIRED AS A RESULT OF THE CARDIAC EVENT, THE ISSUE WITH THE IMPELLA 5.0 DEVICE CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR IN THE OVERALL OUTCOME FOR THIS EVENT.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20813851 ↗
• MalfunctionNov 30, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED THAT A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS BEING IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE IMPELLA 5.0 WOULD NOT CROSS INTO AORTA, THEREFORE THE IMPLANT WAS ABORTED. THE PHYSICIAN HAD THE 5.0 PASSED THE GRAFT BUT COULD NOT CROSS THE INNOMINATE ARTERY. THE DEVICE WAS REMOVED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20813715 ↗
• DeathNov 30, 2024Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE TO REPLACE AN EXISTING IMPELLA CP FOR INCREASED MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED THAT THE PUMP HAD PURGE PRESSURE HIGH ALARMS. TROUBLESHOOTING THE ALARM WITH RAPID DECELERATION TECHNIQUE WAS UTILIZED WITH MINIMAL SUCCESS. DESPITE AGGRESSIVE INOTROPES AND VASOPRESSORS, THE PATIENT CONTINUED TO DETERIORATE, AND THE FAMILY OPTED TO WITHDRAW CARE. THE PATIENT EXPIRED QUICKLY AFTER SUPPORT WAS REMOVED. THE HIGH PURGE PRESSURE IS A PRODUCT MALFUNCTION WHICH CANNOT EXCLUDE THE IMPELLA USE FROM THE OUTCOME OF DEMISE.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20813710 ↗
• DeathNov 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS TO BE IMPLANTED WITH AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH COVID-LIKE SYMPTOMS ON (B)(6) 2021. UPON ARRIVAL, THE PATIENT CODED THREE TIMES IN TWENTY-FOUR HOURS. AN ELECTROCARDIOGRAM PERFORMED NOTED AN ANTERIOR NON-ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY BUT WAS SURGICALLY TURNED DOWN. THE DECISION WAS THEN MADE TO TRANSFER THE PATIENT TO ANOTHER HOSPITAL BUT CODED AS SOON AS THE TRANSPORT TEAM ARRIVED AND WAS DENIED. A RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED. ON (B)(6) 2021, TEN DAYS AFTER ADMISSION, THE 5.0 IMPELLA WAS DECIDED TO BE PLACED TO STABILIZE THE PATIENT FOR TRANSFER. THE IMPELLA 5.0 INSERTION WAS ABORTED DUE TO THE PATIENT'S VASCULAR ANATOMY. THE PHYSICIAN THEN DECIDED TO PLACE AN IMPELLA CP INTO THE AXILLARY ARTERY, AND THE DELIVERY WAS SUCCESSFUL. THE PATIENT REMAINED UNSTABLE, DID NOT IMPROVE AND EXPIRED THREE DAYS LATER. THE CP DEVICE WAS NOTED TO HAVE WORKED AS EXPECTED. GIVEN THE INABILITY TO DELIVER THE 5.0 DEVICE, THE PATIENT UNDERWENT ADDITIONAL INTERVENTION TO PLACE THE IMPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20813671 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME WAS ON AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT SITE BLEEDING WAS OBSERVED DURING THIS PROCESS AND HEMOSTASIS WAS ACHIEVED THROUGH SURGERY. IT WAS REPORTED THAT THE PATIENT BECAME FEBRILE THOUGHT THE NIGHT. IT IS UNKNOWN HOW THE COMPLICATION WAS MANAGED. THE PROCEDURAL OUTCOME NOTED THAT THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Sepsis

  MAUDE report 20813565 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK / LOW CARDIAC OUTPUT SYNDROME WAS ON AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THE PATIENT WAS FEBRILE AND HYPOTENSIVE. THE PROCEDURAL OUTCOME NOTED THAT THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Sepsis

  MAUDE report 20813563 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME WAS ON AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED BLEEDING, WAS NOT ABLE TO BE STABILIZED AND EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20813561 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME WAS ON AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED THROMBOCYTOPENIA, AND BICARBONATE WAS ADDED TO THE PURGE. ADDITIONALLY, IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO PASS THE PUMP INTO THE AXILLARY ARTERY FROM THE GRAFT AND THE AXILLARY ARTERY WAS DISSECTED. THE VESSEL WAS REPAIRED. ADDITIONAL INFORMATION NOTED THE PATIENT WAS MADE A DO NOT RESUSCITATE, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Perforation of Vessels; Thrombocytopenia

  MAUDE report 20813543 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS ON AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED THROMBOCYTOPENIA, THE RESOLUTION FOR THIS ISSUE IS UNKNOWN. ADDITIONALLY, THE PATIENT SUFFERED A STROKE. ADDITIONAL INFORMATION NOTED THE PATIENT WAS MADE A DO NOT RESUSCITATE, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Stroke/CVA; Thrombocytopenia

  MAUDE report 20813537 ↗
• DeathNov 29, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT NOTED WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS)/LOW CARDIAC OUTPUT SYNDROME (LCOS) WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IMPELLA 5.0 WAS ADVANCED INTO AXILLARY ARTERY; HOWEVER, UNABLE TO ADVANCE THROUGH INNOMINATE. REPEATED ATTEMPTS WERE MADE INVOLVING VARIOUS MANIPULATIONS OF THE PATIENT¿S ARM (ABDUCTION), THE GRAFT, AND THE CATHETER. EVENTUALLY, THE DEVICE WAS REMOVED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED ON INNOMINATE PRIOR TO CONTINUED ATTEMPTS TO RE-ADVANCE THE IMPELLA 5.0. DIRECT/OPEN INSERTION AS WELL AS FEMORAL INSERTION WAS DISCUSSED: HOWEVER, THE PATIENT DECOMPENSATED RAPIDLY IN THE OPERATING ROOM WITH INCREASING DIFFICULTY TO ACHIEVE ADEQUATE PERFUSION. THE DECISION WAS MADE TO ABORT IMPELLA 5.0 PROCEDURE WITH THE PATIENT BEING RETURNED TO THE UNIT ON AN IMPELLA CP FOR HEMODYNAMIC SUPPORT WHERE FAMILY MADE THE DECISION TO WITHDRAW CARE AND PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemodynamic instability

  MAUDE report 20813535 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT UNDERGOING CARDIAC SURGERY WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS NOTED THAT THE PATIENT WAS UNSTABLE FROM RETURNING FROM OR. THEY WILL BE GIVING PACKED RED BLOOD CELLS SHORTLY FOR HEMOGLOBIN OF 8.3. NO PURGE HEPARIN HAS BEEN STARTED YET DUE TO BLEEDING AT THE TRACH SITE. IN ADDITION, THE NURSE STATED THAT THE PATIENT¿S URINE STARTED TURNING RED. AN ECHO WAS ORDERED AND SHOWED THAT THE IMPELLA WAS IN GOOD POSITION. 1 UNIT RED BLOOD CELLS WERE GIVEN. ULTIMATELY THE PATIENT EXPIRED ON SUPPORT. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemolysis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20813526 ↗
• InjuryNov 29, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK NEEDING AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. MULTIPLE ATTEMPTS WERE MADE TO PLACE THE IMPELLA INTO POSITION WITHOUT ANY SUCCESS. THE SURGEON TRIED TO MANUALLY REPOSITION, HOWEVER THE IMPELLA PIGTAIL WAS CAUGHT ON HEART STRUCTURES. THE IMPELLA WAS UNABLE TO BE REMOVED OR REPOSITIONED. THE PATIENT STARTED TO DECOMPENSATE AS BLOOD PRESSURE DROPPED INTO THE 40S SYSTOLIC. A DECISION WAS MADE TO DO AN EMERGENT CENTRAL VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO). MULTIPLE PRESSORS WERE INITIATED AND 2 UNITS OF PACKED RED BLOOD CELLS WERE GIVEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS ABORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 20813497 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS)/LOW CARDIAC OUTPUT SYNDROME (LCOS) WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING IMPELLA PLACEMENT, THE PATIENT EXPERIENCED BLEEDING FROM THE CHEST. IT WAS REPORTED THAT BLOOD PRODUCTS WERE PROVIDED, AND THE PURGE FLUID REMAINED DEXTROSE WITH FIVE PERCENT WATER UNTIL BLEEDING WAS RESOLVED. THE DEVICE WAS EXPLANTED, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20812922 ↗
• DeathNov 29, 2024Restricted Flow rate; Restricted Flow rate

  THE COMPLAINANT REPORTED A PATIENT IN POST CARDIOTOMY CARDIOGENIC SHOCK¿AND WITH LOW CARDIAC OUTPUT SYNDROME, WITH AN OPEN CHEST FOR A SURGICAL ABLATION, MITRAL AND AORTIC VALVE REPLACEMENT, AND AORTIC ROOT ANEURYSM REPAIR, WAS IMPLANTED WITH AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED WHILE ON IMPELLA 5.0 SUPPORT, THE PATIENT EXPERIENCED BLEEDING FROM THE PROCEDURES THAT REQUIRED THE PATIENT TO BE TRANSFUSED WITH 7 UNITS OF BLOOD, 2 UNITS OF PLATELETS, AND 2 UNITS OF FACTOR VII. THE PATIENT'S COAGULATION STUDIES WERE REPORTED AS NORMAL, HOWEVER THE PATIENT CONTINUED TO BLEED FROM THEIR CHEST TUBES. THE PATIENT'S CHEST WAS REOPENED TO INVESTIGATE THE SOURCE OF BLEEDING, BUT THE SOURCE WAS UNABLE TO BE LOCATED. THE PHYSICIAN WAS NOT CONCERNED WITH THE IMPELLA AS A CONTRIBUTING FACTOR FOR THE BLEEDING. THE PATIENT WAS TRANSFERRED BACK TO THE ICU ON IMPELLA SUPPORT, WHERE SHORTLY AFTER ARRIVING, THE IMPELLA FLOWS CONTINUED TO REDUCE WITH FREQUENT SUCTION ALARMS. THE PATIENT EXPIRED WHILE ON SUPPORT. GIVEN THE LIMITED INFORMATION SURROUNDING THE DETAILS THE PATIENT'S CONDITION AND CAUSE OF DEATH THE IMPELLA CANNOT BE EXCLUDED AS A POSSIBLE CONTRIBUTING FACTOR, HO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20812305 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING IMPELLA PLACEMENT, THE PATIENT WAS ACTIVELY BLEEDING. THE PATIENT EXPERIENCED AN ESOPHAGEAL BLEED AND VOMITED ROUGHLY THREE HUNDRED CUBIC CENTIMETERS OF BLOOD. IT WAS ALSO REPORTED THAT THE PATIENT WAS PROVIDED WITH ONE UNIT OF RED BLOOD CELLS. HEPARIN WAS HALTED AND REPLACED WITH SODIUM BICARBONATE TO MANAGE THE COMPLICATION. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED, CARE WAS WITHDRAWN, AND THE PROCEDURAL OUTCOME WAS THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20812222 ↗
• DeathNov 29, 2024Restricted Flow rate; Restricted Flow rate

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING IMPELLA PLACEMENT, NUMEROUS SUCTION ALARMS WERE RECEIVED. MEDICAL STAFF DISCUSSED PROBLEMS WITH THE PATIENT EXPERIENCING HEPARIN INDUCED THROMBOCYTOPENIA (HIT). THE PATIENT WAS IN POOR CONDITION. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED, AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Thrombocytopenia

  MAUDE report 20812136 ↗