Impella 0048-0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 00813502011258), received between Nov 23, 2015 and Aug 21, 2024 — classified as 6 deaths, 91 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (20 reports).

22 other recalls cover devices cleared under the same FDA submission (P140003); 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 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION NEEDING AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING IMPLANTATION THERE WERE COMPLICATIONS WITH BLEEDING. THE IMPELLA PEEL AWAY WOULD NOT ADVANCE DUE TO SEVERE TORTUOSITY OF THE ILIACS AND PINCHING FROM INGUINAL LIGAMENT. THE SHEATH WAS TORQUED AND ADVANCED INTO PLACE ONCE THE PANIS WAS MOVED. THE INGUINAL LIGAMENT WAS PINCHING THE PEEL AWAY SHEATH AND WAS PREVENTING THE SHEATH FROM MOVING FORWARD. THE PHYSICIAN REMOVED THE SHEATH AND USED THE RADIAL APPROACH WITH SUCCESS. THE IMPELLA WAS EXPLANTED IN PROCEDURAL AREA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20016962 ↗
• MalfunctionMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PUBLICATION ENTITLED: ¿SEVERE MITRAL REGURGITATION AND BIVENTRICULAR HEART FAILURE SUCCESSFULLY TREATED WITH BIVENTRICULAR PERCUTANEOUS AXIAL FLOW PUMPS AS A BRIDGE TO MITRAL VALVE SURGERY" REPORTED A 61-YEAR-OLD MALE OF UNKNOWN ETHNICITY IN WHICH A BIPELLA RP-CP SUPPORT WAS USED. THE IMPELLA CP WAS EXPLANTED FOR HEMOLYSIS, AND REPLACED BY INTRA-AORTIC BALLOON PUMP (IABP). SUPPORT WAS PROCEEDED WITH THE IMPELLA RP.

  Patient problems: Hemolysis

  MAUDE report 19313862 ↗
• MalfunctionSep 27, 2021Fracture; Fracture

  THE COMPLAINANT REPORTED A (B)(6) MALE PATIENT PRESENTING FOR HIGH RISK PERCUTANEOUS CORONARY INTERVENTION. THE IMPELLA CP WAS SELECTED FOR HEMODYNAMIC SUPPORT. SHORTLY AFTER SUPPORT WAS INITIATED, THE PUMP EXHIBITED CONTINUOUS SUCTION ALARMS. THE PUMP WAS REMOVED AND REPLACED WITHOUT FURTHER ISSUE. AN INVESTIGATION WAS COMPLETED ON THE RETURNED DEVICE AND BROKEN IMPELLER BLADES WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533949 ↗
• InjuryMay 8, 2018Kinked; Difficult to Remove; Device Issue; Kinked; Difficult to Remove; Device Issue

  A PATIENT ADMITTED WITH CARDIOGENIC SHOCK AND ACUTE MI HAD AN IMPELLA CP PLACED WITH DIFFICULTY VIA THE RIGHT FEMORAL ARTERY DURING CPR. DUE TO THE PUMP KINKING, WHEN THE GUIDEWIRE WAS REMOVED, THE PUMP WAS EXPLANTED TO RESOLVE THE KINK. UPON REINSERTION THE RIGHT FEMORAL ARTERY WAS OBSERVED TO BE DISSECTED. THE PATIENT HAD THE DISSECTION TAMPONADE BY THE PLACEMENT OF A 14FR INTRODUCER AND THE CASE AND CPR CONTINUED, UNTIL HIS DEATH FROM CARDIOGENIC SHOCK AND FAILED CPR AND DEFIBRILLATIONS.

  Patient problems: Blood Loss; Perforation of Vessels

  MAUDE report 7496264 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WITH PERIPHERAL ARTERY DISEASE (MULTI-VESSEL VESSEL CORONARY ARTERY DISEASE WITH HIGH GRADE STENOSIS) HAD AN IMPELLA CP PLACED VIA THE RIGHT LEG'S FEMORAL ARTERY. THIS PATIENT HAD PREVIOUSLY UNDERGONE A LOWER LEFT EXTREMITY AMPUTATION. THE IMPELLA CP WAS PLACED TO REST THE HEART. THE PEEL-AWAY SHEATH WAS LEFT IN PLACE TO ALLOW THE CARDIOVASULAR SURGEON TO EVENTUALLY REMOVE THE DEVICE WITHOUT HAVING TO MANAGE THE ACCESS SITE. FOLLOWING BYPASS SURGERY, THE PATIENT DEVELOPED A COLD LEG, RESULTING IN VASCULAR SURGERY, DURING WHICH THE LEG WAS AMPUTATED. THE PATIENT EXPIRED 3 DAYS LATER ON (B)(6) 2018. THE PHYSICIAN REPORTED THAT THE PATIENT OUTCOME WAS UNRELATED TO ANY ISSUE WITH THE IMPELLA RP, AS THE PATIENT WOULD NOT HAVE MADE IT TO THE OR WITHOUT THE SUPPORT OF THE PUMP.

  Patient problems: Ischemia

  MAUDE report 7487724 ↗
• DeathApr 30, 2018Positioning Problem; Positioning Problem

  AN IMPELLA CP WAS PLACED FOR SUPPORT INTO A (B)(6) MALE FOR AMI/CGS. PUMP FLOWS WERE LOW AND POSITION ALARMS WERE TRIGGERED IMMEDIATELY AFTER THE PUMP WAS STARTED. ECHO IMAGING REVEALED PAPILLARY MUSCLE HEAD AND TENDINOUS CHORDS WERE DRAWN INTO THE PUMP INLET. THE CLINICAL TEAM REPEATEDLY ATTEMPTED TO REPOSITION THE DEVICE. THE PATIENT'S CONDITION WAS DETERIORATING THEREFORE THE PUMP WAS REMOVED. THE PATIENT EXPIRED DUE TO CARDIOGENIC SHOCK.

  Patient problems: Injury

  MAUDE report 7472345 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED BLEEDING ISSUES AT THE GROIN AFTER INSERTION. THE PHYSICIAN MANAGED THE BLEEDING WITH PROTAMIN AND PRESSURE DRESSING.

  Patient problems: Blood Loss

  MAUDE report 7441254 ↗
• InjuryApr 10, 2018Kinked; Kinked

  THE COMPLAINANT REPORTED THAT FOLLOWING STENT PLACEMENT IN A 7(B)(6) FEMALE PATIENT AN IMPELLA CP WAS PLACED IN THE LEFT FEMORAL ARTERY WITHOUT THE AID OF FLUORO IMAGING. THE PUMP WAS PLACED DEEP INTO THE LEFT VENTRICLE WHEN THE CANNULA KINKED AND THE PIGTAIL OF THE IMPELLA CP APPEARED TO BE ENTRAPPED IN THE PUMP'S INFLOW CAGE. THE PHYSICIAN WAS UNABLE TO FREE THE PIGTAIL. THE PATIENT WAS TAKEN TO CT SURGERY WHERE THE DEVICE WAS REMOVED FROM THE LEFT VENTRICLE VIA THE AID OF A SNARE. ANOTHER IMPELLA CP WAS OBTAINED AND SUCCESSFULLY PLACED IN THE PATIENT. THE PATIENT WAS SUPPORTED FOR 3.25 HOURS WHEN THE PATIENT'S FAMILY DECIDED TO WITHDRAW CARE, AND PATIENT EXPIRED.

  Patient problems: Blood Loss

  MAUDE report 7415628 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 A CARDIOL RES AND ELMER PRESS INC.¿ JOURNAL ARTICLE WAS FOUND. THE DATE OF THE EVENT WAS NOT REPORTED AND ABIOMED WAS UNABLE TO FIND A CORRESPONDING EVENT THAT HAD BEEN REPORTED FOR ANY CUSTOMER. ABIOMED HAS USED THE MANUSCRIPT SUBMISSION DATE OF (B)(6) 2017 AS THE DATE OF THE EVENT. A (B)(6) YEAR-OLD MALE WITH KNOWN CORONARY ARTERY DISEASE AND STABLE ANGINA WAS ADMITTED TO OUR FACILITY WITH A PROLONGED CHEST PAIN EPISODE AT REST, ASSOCIATED WITH DYSPNEA. AN IMPELLA CP WAS SUCCESSFULLY PLACED. FOLLOWING PCI, THE PATIENT SUFFERED ACUTE PROFOUND HYPOTENSION NECESSITATING INTRAVENOUS FLUIDS AND VASOPRESSOR SUPPORT WITH EPINEPHRINE. THE IMPELLA DEVICE WAS REMOVED AND SELECTIVE LEFT COMMON ILIAC ANGIOGRAM FROM THE RIGHT FEMORAL ACCESS REVEALED A VASCULAR INJURY SITE WITH AN INDICATION OF A RETROPERITONEAL HEMATOMA. AN 8.0 × 59 MM ICAST COVERED STENT WAS DEPLOYED TO THE LEFT EXTERNAL ILIAC ARTERY WITH SUCCESSFUL SEALING OF THE PERFORATION. THE IMPELLA DEVICE SITE WAS CLOSED WITH TWO PERCLOSE DEVICES. COMPUTED TOMOGRAPHY (CT) OF THE ABDOMEN REVEALED LARGE RETROPERITONEAL BLEEDING ALONG THE PLANE OF LEFT EXTERNAL ILIAC ARTERY. THE PATIENT REQUIRED 4 UNITS OF PACKED RED BLOOD

  Patient problems: Blood Loss; Perforation

  MAUDE report 7402781 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE PATIENT WAS EXPERIENCING HEMOLYSIS AND BLEEDING WHILE BEING SUPPORTED BY AN IMPELLA CP. DURING TRANSPORT, SIGNIFICANT BLEEDING OCCURRED AT THE GROIN. FEMSTOP WAS PLACED TO ATTEMPT TO RESOLVE THE BLEEDING. THE PATIENT RECEIVED 8 UNITS OF BLOOD AND THERE WAS NO LASTING HARM. THE PHYSICIAN ESCALATED TO AN IMPELLA 5.0 TO RESOLVE HEMOLYSIS.

  Patient problems: Blood Loss; Hemolysis

  MAUDE report 7402564 ↗
• MalfunctionApr 5, 2018Device Issue; Material Deformation; Positioning Problem; Device Issue; Material Deformation; Positioning Problem

  A (B)(6) YEAR OLD MALE WAS ADMITTED IN CARDIOGENIC SHOCK AND HAD AN IMPELLA CP PLACED FOR HEMODYNAMIC SUPPORT. WHILE ON IMPELLA SUPPORT HE HAD A CORONARY ANGIOPLASTY AND THEN WHEN THE TEAM WAS PREPARING THE PATIENT FOR TRANSPORT TO THE ICU, THEY NOTICED THEY WERE UNABLE TO POSITION THE PUMP'S REPOSITIONING SHEATH DUE TO A SPLIT. THE TEAM HAD TO REVERSE THE ANTICOAGULATION, MONITOR THE PATIENT FOR HIS LITER OF BLOOD LOST, AND PLACE A FEMOSTOP TO THE GROIN SITE.

  Patient problems: Blood Loss

  MAUDE report 7400364 ↗
• InjuryApr 4, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  AN IMPELLA CP WAS PLACED FOR SUPPORT FOR HRPCI INTO A (B)(6) OLD FEMALE PATIENT ON (B)(6). AFTER THE STENT WAS PLACED ECHO REVEALED BLEEDING IN THE PERICARDIUM. THE PATIENT WAS BROUGHT TO THE OR WHERE 400 UNITS OF BLOOD WAS REMOVED, AND A PERFORATION OF THE LEFT VENTRICLE WAS DISCOVERED. THE ORIGIN OF THE PERFORATION IS UNKNOWN.

  Patient problems: Cardiac Perforation

  MAUDE report 7395628 ↗
• InjuryMar 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP WAS PLACED VIA RIGHT FEMORAL ARTERY FOR SUPPORT IN A (B)(6) FEMALE PATIENT FOR AMI/CGS ON (B)(6). THE PUMP SUPPORTED THE PATIENT THROUGH THE INTERVENTION. AFTER THE INTERVENTION THE PATIENT HAD EXPERIENCED LACK OF PEDAL PULSES IN BOTH SIDES, AND ISCHEMIA IN THE RIGHT LEG. THE PATIENT WAS WEANED FROM SUPPORT AND THE PUMP WAS EXPLANTED ON (B)(6). IT WAS REPORTED TO THE ABIOMED FIELD TEAM THAT THE PATIENT'S RIGHT LEG HAD BEEN AMPUTATED.

  Patient problems: Injury; Ischemia; Patient Problem/Medical Problem

  MAUDE report 7370378 ↗
• InjuryMar 19, 2018Kinked; Difficult To Position; Kinked; Difficult To Position

  THE COMPLAINANT REPORTED THAT THE CLINICIANS WERE ATTEMPTING TO PLACE AN IMPELLA CP IN A (B)(6) YEAR OLD FEMALE PATIENT WITH A VERY SMALL AORTIC ARCH. THE CLINICIANS SUCCESSFULLY PLACED THE IMPELLA CP, BUT UPON THE ATTEMPTED REMOVAL OF THE 0.018 GUIDE-WIRE THE CANNULA KINKED. THE PHYSICIANS THEN TRIED TO REPOSITION THE DEVICE BUT WAS UNSUCCESSFUL. THE PUMP WAS REMOVED FROM THE PATIENT, AND REINSERTION WAS ATTEMPTED BUT THE SAME ISSUE OCCURRED. SOON AFTER A TAMPONADE WAS IDENTIFIED WHICH REQUIRED EMERGENCY SURGERY. WHEN THE PATIENT'S CHEST WAS OPENED, A LEFT VENTRICLE PERFORATION WAS FOUND WITH MASSIVE BLEEDING WHICH REQUIRED RECIRCULATION OF BLOOD VIA CARDIOPULMONARY BYPASS. THE PERFORATION WAS SUCCESSFULLY REPAIRED AND HEMOSTASIS WAS ACHIEVED, AND A CORONARY ARTERY BYPASS GRAFT WAS SUCCESSFULLY PLACED. FOLLOWING THIS EVENT, THE PATIENT WAS REPORTED AS DOING WELL. THE PHYSICIAN REPORTED THAT HE BELIEVES THAT PATIENT SIZE AND THE PATIENT'S SMALL AORTIC ARCH CONTRIBUTED TO THE EVENT.

  Patient problems: Blood Loss; Perforation

  MAUDE report 7349476 ↗
• MalfunctionMar 9, 2018Device Issue; Device Issue

  THE COMPLAINANT REPORTED THAT A (B)(6) MAN WAS SUPPORTED WITH AN IMPELLA CP FOR 46.49 HOURS. AFTER APPROXIMATELY 24 HOURS OF PATIENT SUPPORT SUCTION ALARMS OCCURRED. PATIENT SUPPORT CONTINUED FOR ANOTHER 22.49 HOURS. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS ALERT AND ORIENTED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE REPORTED SUCTION. THE DEVICE WAS RETURNED AND THE EVALUATION OF THE PUMP REVEALED LARGE BIOMATERIAL IN THE PUMP HOUSING AND REVEALED IMPELLER DAMAGE CONSISTING OF A DETACHED IMPELLER BLADE. BIOMATERIAL INGESTION IS KNOWN TO CAUSE SUCTION; HOWEVER, THE BIOMATERIAL NEEDED TO BE REMOVED TO COMPLETE THE DEVICE EVALUATION AND THE PUMP COULD NOT BE RUN WITH IT IN PLACE. ALTHOUGH THE PUMP WAS NOT RUN WITH THE BIOMATERIAL PRESENT DURING TESTING, IT CAN BE CONFIDENTLY STATED THAT THERE IS A CHANCE THIS IS WHAT CAUSED THE SUCTION ISSUES REPORTED IN THE CASE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7329022 ↗
• InjuryFeb 28, 2018Break; Break

  THE COMPLAINANT REPORTED THAT THE PATIENT WAS TAKEN TO THE CORONARY CATHETERIZATION LAB FOR REMOVAL WITH BILATERAL ACCESS, CATHETER CROSS-OVER AND BALLOON TAPENADE FOR 20 MINUTES. IN ADDITION 10 TO 15 MINUTES OF MANUAL COMPRESSION WAS PERFORMED. FOLLOWING REMOVAL OF THE IMPELLA CP IT WAS FOUND THAT THE PATIENT'S FEMORAL ARTERY WAS DISSECTED. THE PATIENT WAS TAKEN TO SURGERY WHERE THE ARTERIAL REPAIR WAS SUCCESSFULLY PERFORMED. THE PATIENT'S 19 HOURS OF IMPELLA CP SUPPORT WAS REPORTED AS SUCCESSFUL AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 7304742 ↗
• InjuryFeb 20, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  A (B)(6) MALE WAS ADMITTED WITH INFLUENZA. UPON ADMISSION TO THE HOSPITAL HE HAD A CARDIAC CATHETERIZATION WHICH REVEALED MULTIVESSEL CORONARY ARTERY DISEASE, HAD AN IMPELLA CP PLACED FOR SUPPORT, AND AN ANGIOPLASTY WAS PERFORMED. DURING THE OVERNIGHT HOURS IN THE ICU, THE PATIENT DEVELOPED A HEMATOMA AT THE GROIN SITE AND HE BECAME HYPOTENSIVE. VOLUME, IN THE FORM OF IV FLUIDS, AND BLOOD WAS GIVEN TO THE PATIENT AND THE TEAM EXPLANTED THE IMPELLA CP WITH THE HELP OF THE SURGICAL TEAM. THE PATIENT HAD A NEW IMPELLA 5.0 PLACED AXILLARY AND HIS HEMODYNAMIC SUPPORT CONTINUED.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension

  MAUDE report 7282801 ↗
• InjuryFeb 20, 2018Device Issue; Device Issue

  A (B)(6) MALE WAS ADMITTED WITH INFLUENZA. IN HIS WORKUP MULTIVESSEL CORONARY ARTERY DISEASE WAS DIAGNOSED. HE WAS SENT FOR BYPASS SURGERY WITH IMPELLA CP BEING UTILIZED FOR HEMODYNAMIC SUPPORT. AFTER THE BYPASS GRAFTS WERE PLACED, AND THE PATIENT WAS TAKEN OFF-PUMP, THE IMPELLA GROIN ACCESS SITE WAS SEEN TO HAVE PULSATILE BLOOD FLOW. DUE TO THE BLOOD LOSS, THE IMPELLA WAS EXPLANTED, AND THE PATIENT HAD A SURGICAL INTERVENTION AND REPAIR OF THE TORN COMMON FEMORAL ARTERY. A NEW IMPELLA CP WAS PLACED FOR CONTINUED SUPPORT AT THE LEFT FEMORAL ARTERY, VIA A NEWLY PLACED 6CM HEMASHIELD PLATINUM GRAFT, AND HIS HEMODYNAMIC SUPPORT CONTINUED UNTIL SUPPORT WAS WITHDRAWN AT THE REQUEST OF THE FAMILY.

  Patient problems: Blood Loss; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 7282770 ↗
• InjuryFeb 1, 2018Physical Property Issue; Physical Property Issue

  AN IMPELLA CP WAS IMPLANTED ON (B)(6). THERE WAS DIFFICULTY INSERTING THE REPOSITIONING SHEATH COMPLETELY IN, AND THE PHYSICIAN ATTEMPTED TO REPOSITION IT. THE PATIENT RECEIVED TWO UNITS OF BLOOD DUE TO BLEEDING FROM THE INSERTION SITE DURING THE CASE. UPON REMOVAL OF THE IMPELLA CP, THE REPOSITIONING SHEATH APPEARED TO BE DAMAGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7234380 ↗
• MalfunctionJan 30, 2018Device Operates Differently Than Expected; Torn Material; Device Operates Differently Than Expected; Torn Material

  A (B)(6) MALE TRANSPORTED HIMSELF TO THE HOSPITAL EMERGENCY ROOM AND PROMPTLY CODED, WENT INTO VENTRICULAR TACHYCARDIA, AND AFTER SUCCESSFUL RESUSCITATION, WAS TAKEN TO THE CARDIAC CATH LAB. AN ANGIOPLASTY WAS PERFORMED WITH AN IMPELLA CP BEING UTILIZED FOR HEMODYNAMIC SUPPORT. AFTER THE ANGIOPLASTY THE PATIENT WAS SENT TO THE ICU WITH THE CP FOR CONTINUED SUPPORT AND MONITORING. WHILE IN THE ICU THE PUMP POSITION WAS CHECKED VIA ECHO AND REPOSITIONED. AFTER REPOSITIONING, THE TEAM NOTICED A GROIN ACCESS SITE HEMATOMA WAS DEVELOPING AND BEGAN TO HOLD PRESSURE AT THE SITE. THE PATIENT'S HEART RATE INCREASED AND BLOOD PRESSURE WAS DECREASING AT THIS TIME. WHEN THE BLEEDING WAS UNABLE TO BE CONTROLLED, AND WITH THE PATIENT CONDITION DETERIORATING, THE TEAM CHOSE TO SEND THE PATIENT TO THE OPERATING ROOM (OR) FOR EVALUATION OF THE GROIN SITE. WHILE IN THE OPERATING ROOM (OR), THE CARDIOTHORACIC SURGEON PERFORMED A CUTDOWN TO THE SITE AND THE VESSEL WAS REPAIRED. THE TEAM DID NOT INFUSE ANY BLOOD PRODUCTS AND NOTED THE PATIENT TO BE STABLE AFTER VESSEL REPAIR AND IMPELLA CP EXPLANT. UPON REVIEW OF THE CP POST EXPLANT THE TEAM NOTED THAT THE REPOSITIONING SHEATH OF THE CP HAD A TEAR OF U

  Patient problems: Blood Loss; Hematoma; Low Blood Pressure/ Hypotension

  MAUDE report 7227258 ↗
• InjuryJan 19, 2018Crack; Crack

  ON (B)(6) 2017 AN IMPELLA CP WAS INSERTED IN THE LEFT GROIN OF A (B)(6) MALE PATIENT. THE PUMP WAS PLACED WITHOUT ISSUE. THE PATIENT WAS THEN REMOVED FROM THE CATH LAB AND WAS TAKEN TO THE OPERATING ROOM FOR BY-PASS SURGERY. AT THIS TIME IT WAS NOTICED THAT THE PUMP FLOWS AND PRESSURES WERE DROPPING. A HEMATOMA WAS FOUND IN THE PATIENT'S GROIN. MANUAL PRESSURE WAS HELD. IT WAS THEN OBSERVED THAT BLOOD WAS ACTUALLY COMING FROM THE REPOSITIONING SHEATH, WHICH WAS FOUND TO BE CRACKED. A CUT-DOWN PROCEDURE WAS PERFORMED AND PROXIMAL AND DISTAL PURSE STRING WERE APPLIED TO THE FEMORAL ARTERY. THE REPOSITIONING SHEATH WAS REMOVED FROM THE ARTERY, WHILE THE IMPELLA CP REMAINED IN THE PATIENT. A THREE VESSEL CABG WAS SUCCESSFULLY PERFORMED. THE IMPELLA CP WAS SUTURED TO THE PATIENT'S GROIN, WITH A PLAN TO LEAVE THE PUMP IN THE PATIENT'S FOR A COUPLE OF DAYS. PULSES WERE PALPABLE IN THE AFFECTIVE GROIN, AND THE SITE WAS REPORTED TO LOOK MUCH BETTER WITH NO HEMATOMA, AND THE AREA WAS SOFT BUT WAS MUCH BRUISED. THE IMPELLA WAS REMOVED FROM THE PATIENT ON (B)(6) 2017, AFTER 54.98 HOURS OF SUCCESSFUL PATIENT SUPPORT. THE PHYSICIAN REPORTED THAT HE WAS VERY HAPPY WITH THE PATIENT'S RECOVERY AND

  Patient problems: Blood Loss; Hematoma

  MAUDE report 7205913 ↗
• InjuryJan 19, 2018Positioning Problem; Positioning Problem

  A (B)(6) YEAR OLD FEMALE PATIENT PRESENTED WITH A HISTORY OF PRIOR CABG AND MITRAL VALVE REPLACEMENT, ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK ON (B)(6). AN IMPELLA CP WAS IMPLANTED SUCCESSFULLY ON (B)(6) FOLLOWING REMOVAL OF AN IABP. THE PATIENT WAS EXPERIENCING LEG ISCHEMIA ON (B)(6). THE CLINICAL STAFF NOTED THE PATIENT'S POSTERIOR TIBIAL PULSES HAD BEEN DOPLER AUDIBLE AT BASELINE, HOWEVER ON THE 21ST TIBIAL PULSES BECAME DOPLER ABSENT DISTAL TO THE IMPELLA SITE. ULTRASOUND REVEALED AN OCCLUSIVE THROMBUS, HOWEVER THE DECISION WAS MADE NOT TO DO INTERVENTION AT THAT TIME DUE TO THE GRAVE PROGNOSIS. THE PATIENT WAS REPORTEDLY VERY UNSTABLE AND WAS SHOCKED SEVERAL TIMES ON THE (B)(6), AND THE FAMILY ELECTED TO WITHDRAW CARE.

  Patient problems: Hemolysis; Patient Problem/Medical Problem

  MAUDE report 7205840 ↗
• InjuryJan 19, 2018Malposition of Device; Malposition of Device

  A (B)(6) FEMALE WAS ADMITTED WITH CARDIOGENIC SHOCK AND ACUTE MI. UPON ADMISSION TO THE CARDIAC CATH LAB SHE HAD AN ANGIOPLASTY (PCI) OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AFTER THE LAD PCI WAS SUCCESSFULLY COMPLETED THE TEAM CHOSE TO PLACE AN IMPELLA CP FOR HEMODYNAMIC SUPPORT. SHORTLY AFTER THE CP WAS PLACED THERE WAS A "WRONG POSITION" ALARM AND THE PHYSICIAN CHOSE TO ADJUST THE POSITION WITHIN THE LEFT VENTRICLE (LV) UNDER FLUOROSCOPIC GUIDANCE. WHILE MOVING THE CP DEEPER INTO THE LV THERE WAS A FEELING OF RESISTANCE AND SO THE PHYSICIAN STOPPED ADVANCING THE CP. THE POSITION ALARM RESOLVED AT THAT TIME, THOUGH NOW THE CONSOLE ALARMED FOR SUCTION. AGAIN UNDER IMAGING GUIDANCE, THIS TIME ECHO RATHER THAN FLUOROSCOPY, THE CP WAS REPOSITIONED AND AT THIS TIME THE TEAM NOTED THE LV TO BE DEPRESSED AND HAVE AN EFFUSION. THE TEAM URGENTLY BEGAN TO TREAT HER FOR THE EFFUSION WITH A CODE BEING CALLED AND A PERICARDIOCENTESIS BEING PERFORMED. THE PERICARDIOCENTESIS WITHDREW BLOOD FROM THE CAVITY. THE TEAM DID INFUSE BLOOD PRODUCTS BACK TO THE PATIENT AND TOOK HER TO THE OR TO REPAIR THE LV PERFORATION. THE PERFORATION WAS NOTED TO BE ON THE POSTERIOR PORTION OF THE HEAR

  Patient problems: Blood Loss; Perforation

  MAUDE report 7205713 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE WITH A HISTORY OF MULTIVESSEL CORONARY ARTERY DISEASE WAS ADMITTED FOR REVASCULARIZATION VIA AN ANGIOPLASTY OF THE CHRONIC TOTALLY OCCLUDED RIGHT CORONARY ARTERY (RCA). THE PATIENT HAD A SUCCESSFUL PROCEDURE, BUT WHEN BEING MOVED FROM THE CARDIAC CATHETERIZATION LAB, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND SUBSEQUENTLY CODED DUE TO A THROMBOSED RCA. THE PATIENT WAS AGAIN INTERVENED UPON AND THE RCA WAS RE-OPENED. DUE TO HIS INSTABILITY, THE IMPELLA CP WAS PLACED FOR HEMODYNAMIC SUPPORT, A TEMPORARY PACEMAKER WAS PLACED, AND A HYPOTHERMIA PROTOCOL WAS INITIATED. ONCE THE IMPELLA CP WAS PLACED, THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING. DURING HIS TWO DAYS IN THE ICU, THE IMPELLA PUMP POSITION WAS CONFIRMED AND THE PATIENT TREATED WITH CARDIAC IV DRIPS AND EVALUATED BY VASCULAR SURGERY. VASCULAR WAS CONSULTED DUE TO A COOL LIMB IN THE LEG THE IMPELLA WAS PLACED. THE SURGEON CHOSE NOT TO TREAT THE LEG, RATHER TO ALLOW THE IMPELLA TO REMAIN WITHIN THE LEFT LEG FOR HEMODYNAMIC SUPPORT UNTIL THE PATIENT COULD BE WEANED FROM THE IMPELLA HEMODYNAMIC SUPPORT. THE FOLLOWING DAY THE PATIENT'S LIMB WAS IMPROVING BUT IT WAS STILL DECIDED TO WEAN THE PATIENT

  Patient problems: Ischemia

  MAUDE report 7182095 ↗
• InjuryDec 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED THAT A (B)(6) MALE PATIENT WAS BEING TREATED AT THE FACILITY AS A RESULT OF HAVING EXPERIENCED 2 SUCCESSIVE DAYS OF INTERNAL CARDIAC DEFIBRILLATOR (ICD) SHOCKS OF INCREASING FREQUENCY DUE TO A VENTRICULAR TACHYCARDIA HEART RHYTHM. THE PATIENT WAS REPORTED TO HAVE A HISTORY OF MULTIPLE COMORBIDITIES INCLUDING A CORONARY BYPASS GRAFT PERFORMED 22 YEARS AGO, HYPERTENSION, HYPERSENSITIVITY LUNG DISEASE, CHRONIC KIDNEY DISEASE, DIABETES MELLITUS, CHRONIC MYOFASCIAL PAIN, CARDIOMYOPATHY, AND AN IMPLANTED BIVENTRICULAR PACEMAKER AND CARDIOVERTER-DEFIBRILLATOR. UPON ADMISSION TO THE HOSPITAL THE PATIENT HAD AN EJECTION FRACTION OF 15%, AND HIS ACT WAS OVER 300. ON (B)(6) 2017 A VENTRICULAR TACHYCARDIA ABLATION WAS PERFORMED IN THE EP LAB. AFTER THE PHYSICIAN BURNED A COUPLE OF SITES DURING THE PROCEDURE THE PATIENT WENT INTO A PULSELESS ELECTRICAL ACTIVITY (PTA) AND ARRESTED. CPR WAS THEN INITIATED. THE IMPELLA CP WAS THEN PLACED IN THE PATIENT VIA THE LEFT FEMORAL ARTERY (LFA) WITHOUT DIFFICULTY. DURING THE IMPELLA SUPPORT THE PATIENT WOULD DRIFT INTO PERIOD OF NO EJECTION, THEN NO CONTRACTILITY WHATSOEVER, REQUIRING FURTHER COMPRESSIONS. THE DECISION WAS THEN MAD

  Patient problems: Blood Loss; Hematoma

  MAUDE report 7140206 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140003. One submission often covers many models, so check the product and lot details in each record.

• Z-3149-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella
• Z-3148-2026 · Aug 12, 2026 · Open, Classified
  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella
• Z-3150-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Conn
• Z-2457-2026 · May 18, 2026 · Open, Classified
  Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
• Z-2360-2026 · May 14, 2026 · Open, Classified
  Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; P
• Z-2211-2026 · Apr 20, 2026 · Open, Classified
  Automated Impella Controller (AIC); Product Code: 0042-0000-US;
• Z-1589-2026 · Feb 18, 2026 · Open, Classified
  Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5
• Z-1591-2026 · Feb 16, 2026 · Open, Classified
  Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Contr
• Z-1030-2026 · Dec 4, 2025 · Open, Classified
  Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
• Z-0069-2026 · Oct 1, 2025 · Open, Classified
  Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product
• Z-0136-2026 · Sep 16, 2025 · Open, Classified
  Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella
• Z-2164-2025 · Jun 23, 2025 · Open, Classified
  Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella
• Z-2319-2024 · May 31, 2024 · Open, Classified
  Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
• Z-0980-2024 · Dec 27, 2023 · Open, Classified
  Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5
• Z-0636-2024 · Dec 6, 2023 · Open, Classified
  Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.

…and 7 more.