Abiomed 14Fr Low Profile Introducer 1000458Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00813502013269), received between Dec 31, 2025 and Jun 15, 2026 — classified as 5 deaths, 26 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K222113); 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Difficult to Advance

  THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE VIA THE LEFT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT IMPLANTATION OF AN IMPELLA CP WAS ABORTED DUE TO PATIENT ANATOMY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511811 ↗
• InjuryJun 10, 2026Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 56-YEAR-OLD FEMALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), IMPELLA RUNNING AT P-5 WITH FLOWS AT 2.1 LITERS PER MINUTE. DISTAL LIMB ISCHEMIA IDENTIFIED BY LOSS OF PULSES ON IMPELLA INSERTION SIDE AND DEVICE SUBSEQUENTLY REMOVED. IT IS UNKNOWN IF LIMB ISCHEMIA RESOLVED AS A RESULT OF DEVICE REMOVAL. ADDITIONAL INFORMATION RECEIVED FROM THE ABIOMED REPRESENTATIVE INDICATED THAT THE ISCHEMIA OCCURRED DURING INSERTION OF THE INTRODUCER. AFTER 18 HOURS OF SUPPORT, THE PATIENT EXPIRED FROM A BRAIN BLEED. IT WAS NOTED THAT SODIUM BICARBONATE WAS IN THE PURGE SOLUTION. THE IMPELLA IS BEING CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT IN CARDIAC ARRE

  Patient problems: Ischemia

  MAUDE report 25461499 ↗
• InjuryMay 11, 2026No Apparent Adverse Event; Patient Device Interaction Problem

  UPDATE CLINICAL NARRATIVE: A 73-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK (PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE C) WAS SUPPORTED WITH AN IMPELLA CP DEVICE IMPLANTED ON (B)(6) 2026 AT 09:52 AM AND EXPLANTED ON (B)(6) 2026. THE IMPELLA CP WAS SUCCESSFULLY EXPLANTED FROM THE PERCUTANEOUS RIGHT AXILLARY ARTERY USING TWO PERCLOSE DEVICES AND ONE ANGIO-SEAL CLOSURE DEVICE. IMMEDIATELY FOLLOWING VASCULAR CLOSURE AND DURING ROUTINE FOLLOW-UP ANGIOGRAPHY, ACUTE CESSATION OF FLOW WAS NOTED AT THE RIGHT AXILLARY ARTERY CLOSURE SITE PRIOR TO LEAVING THE CATHETERIZATION LABORATORY. MULTIPLE ATTEMPTS TO CROSS THE LESION WITH WIRES IN ORDER TO BALLOON THE SITE WERE UNSUCCESSFUL. THE IMPLANTING PHYSICIAN ATTRIBUTED THE OBSERVED ISCHEMIA TO THE VASCULAR CLOSURE DEVICES (PERCLOSE AND/OR ANGIO-SEAL). FURTHER EVALUATION DEMONSTRATED PERSISTENT PALPABLE PULSES AND MAINTAINED PERFUSION TO THE RIGHT ARM AND HAND, AND NO WORSENING ISCHEMIC COMPLICATIONS WERE OBSERVED. AS THE PATIENT REMAINED CLINICALLY STABLE WITH PRESERVED EXTREMITY PULSES. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR POST-PROCEDURAL MANAGEMENT, WITH A PLAN TO REASSESS AND C

  Patient problems: Ischemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135274 ↗
• DeathMay 4, 2026Use of Device Problem

  AN IMPELLA CP WAS INSERTED VIA THE 14FR SHEATH AT THE FEMORAL ARTERY TO SUPPORT THE 72-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE TEAM RETAINED THE 14FR SHEATH, AND DID NOT PEEL IT AWAY, TO USE THE INTRODUCER SIDE PORT TO TRANSDUCE FOR BLOOD PRESSURE MONITORING. THE RETENTION OF THE INTRODUCER GOES AGAINST BEST PRACTICES. THE RISKS OF RETAINING THE INTRODUCER WAS DISCUSSED, AND IT WAS NOT PEELED AWAY. THE PATIENT EXPIRED AFTER HOURS OF SUPPORT WHEN THE DECISION WAS MADE TO WITHDRAW CARE. THERE WAS NO ALLEGATION MADE OF PUMP NOT PERFORMING AS INDICATED OR ANY MALFUNCTION OR HARM FROM THE CP PUMP USE. THE DEATH IS REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE E AND THE DECISION TO WITHDRAW CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073320 ↗
• InjuryMay 4, 2026Deformation Due to Compressive Stress

  AN IMPELLA CP WAS BEING INSERTED VIA THE 14FR INTRODUCER AT THE FEMORAL ARTERY TO SUPPORT A 81 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE. THE PLAN WAS TO PERFORM A PROTECTED PERCUTANEOUS CORONARY INTERVENTION WITH HEMODYNAMIC SUPPORT PROVIDED BY THE CP PUMP. AT THE FIRST REVIEW OF THE NATIVE ANATOMY THE TEAM BELIEVED THE VESSEL TO BE APPROPRIATELY SIZED BUT, THERE WAS PERIPHERAL ARTERIAL DISEASE AS THE VASCULATURE WAS TORTUOUS AND CALCIFIED. THE 14FX13CM SHORT INTRODUCER SHEATH WAS PLACED BUT THE CP WOULD NOT DELIVER VIA IT, SO THEY REMOVED AND PLACED THE LONGER 14FR SHEATH, BUT IT TOO WOULD NOT ALLOW THE CP TO PASS AND DELIVER. AS SUCH, SUPPORT WAS ABORTED. WITH REVIEW THE TEAM DID OBSERVE THE INTRODUCER SHEATH TO HAVE KINKED. THE ATTEMPTED DELIVERY WAS ABORTED AND NO HARM OR INJURY WAS NOTED TO THE VESSEL. NATIVE ANATOMY PRECLUDED THE PUMP PLACEMENT. PATIENT SURVIVED THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067576 ↗
• MalfunctionApr 16, 2026Failure to Advance

  IT WAS REPORTED THAT IMPLANTATION OF AN IMPELLA CP WAS ABORTED AS THE PEEL AWAY SHEATH COULD NOT BE ADVANCED PAST THE ILIAC ARTERY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895007 ↗
• MalfunctionMar 30, 2026Break; Difficult to Insert

  THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP VIA PERCUTANEOUS RIGHT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. THE 14 X 25 PEEL AWAY SHEATH PEELED AWAY FROM THE DILATOR UPON INSERTION. THE PATIENT DID HAVE VERY TORTUOUS ANATOMY. THIS MAY HAVE HAPPENED BECAUSE THE DILATOR WAS NOT TWISTED ON PROPERLY TO LOCK IN TO PLACE. IT IS POSSIBLE THE DILATOR WAS PUSHED BACK ON INSERTION CAUSING THE SHEATH TO BECOME SEPARATED AS IT WENT THROUGH THE SKIN. THE PROCEDURE OUTCOME WAS SUCCESSFUL AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714110 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL NARRATIVE: A 76 YEAR OLD FEMALE UNDERGOING HIGH RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH PRE SUPPORT CLINICAL STATUS CONSISTENT WITH SCAI SHOCK STAGE A DEVELOPED A LEFT COMMON FEMORAL ARTERY (LCFA) ACCESS SITE HEMATOMA PRIOR TO INSERTION OF THE IMPELLA PEEL AWAY SHEATH. DESPITE CALCIFIED VESSELS, THE PATIENT'S ARTERIES REMAINED WIDELY PATENT. HRPCI WITH IMPELLA SUPPORT WAS COMPLETED. DURING ATTEMPTS TO TIGHTEN THE PERCLOSE SUTURE POST EXPLANT, THE SUTURE DETACHED FROM THE ARTERY; MANUAL PRESSURE WAS APPLIED, AND A SECOND PERCLOSE ATTEMPT WAS UNSUCCESSFUL DUE TO A DILATED ARTERIOTOMY. A TWO SHEATH TECHNIQUE WAS ATTEMPTED BUT DID NOT ACHIEVE CLOSURE. REPEAT CONTRALATERAL ACCESS ALLOWED PTA BALLOONING AT THE LCFA ARTERIOTOMY SITE, PERFORMED WITH TWO INFLATIONS, RESULTING IN A STABLE SITE. FINAL ANGIOGRAPHY SHOWED A PATENT LCFA WITH GOOD DISTAL RUNOFF AND NO EXTRAVASATION. MD CONFIRMED THAT NEITHER THE IMPELLA SHEATH NOR PUMP CAUSED THE VASCULAR INJURY. THE PATIENT REMAINED STABLE AND SURVIVED TO EXPLANT.

  Patient problems: Hematoma

  MAUDE report 24700825 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak; Device Damaged by Another Device

  CLINICAL NARRATIVE: IMPELLA CP WAS INSERTED VIA FEMORAL ARTERY IN A 78 YEAR OLD FEMALE PATIENT FOR A PROTECTED PCI. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS UNKNOWN. THE IMPELLA WAS INSERTED WITHOUT INCIDENT. SINGLE ACCESS WAS ATTEMPTED WITH A 6FR DESTINATION SHEATH AS THE SECONDARY SHEATH, IT APPEARED THAT THE 6FR DESTINATION WAS INSERTED TO THE HUB OF THE 14FR PEEL AWAY SHEATH, WHICH IS NOT THE RECOMMENDED PRACTICE. THERE WAS BLEEDING NOTED FROM THE BACKSIDE OF THE SHEATH HUB UNTIL SINGLE ACCESS WAS ABORTED. THE PCI WAS THEN PERFORMED THROUGH THE WRIST.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24697999 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL RATIONALE: AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 63-YEAR-OLD MALE PATIENT PRESENTING WITH CARDIOMYOPATHY, SCAI SHOCK STAGE E. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE CARE TEAM NOTED A SMALL HEMATOMA AROUND THE RIGHT AXILLARY IMPELLA INSERTION SITE WITH A SMALL AMOUNT OF OOZING. MANUAL PRESSURE WAS APPLIED, BLEEDING STOPPED, AND THE HEMATOMA STABILIZED AND BEGAN TO SHRINK. THE PATIENT REMAINS ON SUPPORT. THE REPORTED HEMATOMA IS CONSISTENT WITH ACCESS-SITE COMPLICATIONS AND THE ANTICOAGULATION/PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT.

  Patient problems: Hematoma

  MAUDE report 24681457 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP DEVICE WAS INSERTED PERCUTANEOUSLY INTO THE RIGHT FEMORAL ARTERY IN A 71-YEAR-OLD FEMALE WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) PRESENTING IN SCAI STAGE C SHOCK ON INTOTROPES, VASSOPRESSORS, AND RESPIRATORY SUPPORT VIA NASAL CANNULA (NC) PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT PRIOR TO PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PPCI) OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT CIRCUMFLEX (LCX) ARTERY. PRIOR TO VASCULAR ACCESS, THE PATIENT HAD WEAK PULSES IN THE LOWER RIGHT LIMB. THE PATIENT WAS NOTED TO HAVE PERIPHERAL ARTERY DISEASE (PAD)/PERIPHERAL VASCULAR DISEASE (PVD). DURING OR AFTER INTRODUCER INSERTION, THE PATIENT BECAME UNCOMFORTABLE AND COMPLAINED OF PAIN IN THE LOWER RIGHT LIMB DISTAL TO THE VASCULAR ACCESS POINT. THE PATIENT WAS SUCCESSFULLY WEANED, AND THE IMPELLA DEVICE WAS EXPLANTED IN THE PROCEDURAL AREA AND PRECLOSED WITH PERCLOSE PROGLIDE X 2. POST-EXPLANT, DISTAL PULSES DID NOT RETURN AS EXPECTED CONSISTENT WITH LIMB ISCHEMIA. A FEMORAL ANGIOGRAM REVEALED POSITIVE FLOW PAST THE ACCESS POINT. THE POST-PROCEDURE OUTCOME WAS SURVIVED AT EXPLANT. LIMB ISCHEMIA MAY BE INFLUENCED

  Patient problems: Ischemia; Pain

  MAUDE report 24619365 ↗
• DeathMar 9, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 82-YEAR-OLD FEMALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN SCAI STAGE E SHOCK, ON AN INTRA-AORTIC BALLOON PUMP (IABP), ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT DURING THE PROCEDURE, A DISTAL PERFUSION CATHETER (DPC) WAS PLACED DUE TO NO FLOW AROUND THE PEEL-AWAY SHEATH PRIOR TO REMOVAL, AND NO DOPPLER DISTAL PULSES. THE DPC RESOLVED THE ISSUE. IN ADDITION, THE IMPELLA KEPT SUCTIONING PASSED P-3 THEN P-2. THE MEAN ARTERIAL PRESSURE (MAP) WAS 30-40'S ON THE AUTOMATED IMPELLA CONTROLLER (AIC). BLEEDING AND A DROP IN THE HEMOGLOBIN OCCURRED PRIOR TO THE PATIENT ARRIVING TO THE CATH LAB. BLOOD AND OTHER BLOOD PRODUCTS WERE TRANSFUSED FOR VOLUME. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING AND HEMODYNAMIC INSTABILITY TO THE IMPELLA. A FEW HOURS AFTER IMPELLA INSERTION THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEAT

  Patient problems: Ischemia

  MAUDE report 24551350 ↗
• InjuryMar 8, 2026Fluid/Blood Leak

  A 58-YEAR-OLD MAN UNDERWENT HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH IMPELLA CP SUPPORT. THE PUMP WAS IMPLANTED SUCCESSFULLY BUT BLEEDING WAS OBSERVED AROUND THE COMPANION SHEATH AFTER IT'S PLACEMENT. THIS SHEATH WAS REMOVED AND ALTERNATE ACCESS SECURED TO CONDUCT THE PCI PROCEDURE. THE SHEATHS WERE REMOVED AT THE END OF THE CASE AND HEMOSTASIS SECURED USING CONVENTIONAL TECHNIQUES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24542088 ↗
• InjuryMar 6, 2026Crack; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA THE 14FR SHEATH AT THE FEMORAL ARTERY TO SUPPORT THE 78 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH THE INDICATION OF A PROTECTED CORONARY ANGIOPLASTY, FOR THE KNOWN CORONARY ARTERY DISEASE. THE 14FR INTRODUCER WAS SEEN TO BE BLEEDING. THE SHEATH WAS REMOVED DUE TO THE BLOOD LOSS AND WAS SEEN TO HAVE A CRACK. THE TEAM PLACED A NEW INTRODUCER AND SUPPORT PROCEEDED. THE IMPELLA SYSTEM WAS EXPLANTED AFTER THE CORONARY ANGIOPLASTY. NO BLOOD PRODUCTS WERE INFUSED AND NO OTHER INTERVENTION WAS SHARED. THE PATIENT SURVIVED THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24530503 ↗
• MalfunctionMar 4, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE IMPELLA PUMP THE INTRODUCER APPEARED TO BE CRACKED AND BLOOD WAS SEEN POURING OUT OF THE BOTTOM OF THE SHEATH. THE 30 CM SHEATH WAS EXCHANGED FOR THE 13 CM SHEATH AND THE DILATOR WAS INSERTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505489 ↗
• InjuryFeb 27, 2026Deformation Due to Compressive Stress

  CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS ATTEMPTED VIA RIGHT FEMORAL ARTERY IN A 71 YEAR OLD MALE ADMITTED FOR A CARDIAC ABLATION. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE A. DURING IMPLANT, THE DEVICE COULD NOT BE IMPLANTED DUE TO PATIENT ANATOMY. DUE TO TORTUOSITY OF THE VESSELS, THE INTRODUCER SHEATH KINKED AND ATTEMPTS TO PASS THROUGH VASCULATURE WERE UNSUCCESSFUL. THE CP IMPLANT WAS ABORTED AND THE ABLATION PROCEEDED WITHOUT IMPELLA SUPPORT. THE DELIVERY ISSUE AND DAMAGED/KINKED INTRODUCER SHEATH WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE POSITION ATTEMPTS, HOWEVER THE ATTEMPTS AND REMOVAL WERE PERFORMED WITH NO CONSEQUENCE TO THE PATIENT.

  Patient problems: Hemodynamic instability

  MAUDE report 24470375 ↗
• MalfunctionFeb 26, 2026Component Missing

  THE COMPLAINANT REPORTED AN ISSUE WITH THE IMPELLA SHEATH AND INSERTION KIT IDENTIFIED DURING USE IN THE CATHETERIZATION LABORATORY. UPON OPENING THE KIT, IT WAS OBSERVED THAT THE SET CONTAINED TWO SHORT DILATORS AND WAS MISSING THE LONG 14 FR DILATOR. THE PHYSICIAN ELECTED TO PROCEED WITH THE PROCEDURE USING THE SHORT SHEATH, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SIGNS OR SYMPTOMS OF PATIENT INJURY WERE REPORTED, AND NO HARM WAS ASSOCIATED WITH THE EVENT. THE DEVICE WAS EXPLANTED SUCCESSFULLY AFTER WEANING. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED COMPLICATION. AT THE TIME OF EXPLANT, THE PATIENT SURVIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457767 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP WAS IMPLANTED IN A 64-YEAR-OLD MALE VIA LEFT FEMORAL ARTERY ACCESS FOR MANAGEMENT OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (SCAI STAGE E). THE PATIENT HAD KNOWN CORONARY ARTERY DISEASE AND DIABETES MELLITUS AND WAS RECEIVING EXTRACORPOREAL MEMBRANE OXYGENATION, INOTROPES, VASOPRESSORS, AND VENTILATOR SUPPORT AT THE TIME OF IMPLANTATION. PRE-IMPLANT LABORATORY VALUES INCLUDED A LACTATE OF 12.0 MMOL/L AND ALT OF 276 U/L, CONSISTENT WITH SEVERE SHOCK PHYSIOLOGY. THE PURGE SOLUTION CONSISTED OF D5W WITH 25 MEQ SODIUM BICARBONATE. THE COMPLAINT STATES THAT A HEMATOMA DEVELOPED IN THE GROIN ACCESS AREA WITH ASSOCIATED MINOR BLEEDING. NO BLOOD TRANSFUSION WAS REPORTED, AND NO SURGICAL INTERVENTION WAS REQUIRED. THE ACCESS SITE WAS READDRESSED WITH LOCAL MANAGEMENT, AFTER WHICH NO FURTHER ESCALATION OF CARE WAS DESCRIBED. HEMATOMA AND MINOR BLEEDING AT FEMORAL ACCESS SITES ARE KNOWN AND EXPECTED RISKS ASSOCIATED WITH LARGE-BORE ARTERIAL ACCESS AND ARE DESCRIBED IN THE INSTRUCTIONS FOR USE. CONTRIBUTING FACTORS MAY INCLUDE ANTICOAGULATION, SHOCK-RELATED COAGULOPATHY, VASOPRESSOR USE, AND UNDERLYING CRITICAL ILLNESS. DUE TO ONGOING HEMODYNAMIC INSTABILITY

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24437252 ↗
• MalfunctionFeb 20, 2026Fluid/Blood Leak; Device Damaged by Another Device

  ON (B)(6) 2025, A 79-YEAR-OLD MAN PRESENTED FOR A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION. DURING VASCULAR SHEATH PLACEMENT, BLEEDING WAS OBSERVED AT THE SHEATH VALVE. THE BLEEDING WAS CONTROLLED MANIPULATING THE SYSTEM, REMOVING THE SHEATH VALVE AND APPLYING COMPRESSES WITH MANUAL PRESSURE. THE IMPELLA DEVICE REMAINED IN PLACE AND PROVIDED SUPPORT THROUGHOUT THE PROCEDURE. NO ADDITIONAL DEVICE MALFUNCTIONS OR ADVERSE CLINICAL EVENTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24405970 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN AN 85-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), ON MULTIPLE INOTROPES AND VASOPRESSORS, AND IN SCAI STAGE D SHOCK, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI). AFTER EXPLANT OF THE IMPELLA CP, THE PATIENT DEVELOPED A COLD LEG. VASCULAR SURGERY WAS REQUIRED TO TREAT THE LIMB ISCHEMIA. THE POST-PROCEDURE OUTCOME IS UNKNOWN. LIMB ISCHEMIA IS LISTED AS A POTENTIAL ADVERSE EVENT AND CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Ischemia

  MAUDE report 24387636 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  AN IMPELLA 5.5 WAS PLACED VIA THE AXILLARY ACCESS GRAFT SITE FOR THE SUPPORT OF A 66 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH CARDIOMYOPATHY AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE PATIENT WAS ON INOTROPES AND VASOPRESSORS AND A VENT FOR RESPIRATORY NEEDS. THE 5.5 POSITION WAS CONFIRMED BY IMAGING AND THE SHEATH WAS REMOVED AND THE POCKET WAS CLOSED. AFTER 10-15 MINUTES OF SUPPORT SHE EXPERIENCED HYPOTENSION AND THE SURGICAL TEAM RE-IMAGED WITH TEE ECHO TO OBSERVE THERE WAS AN EFFUSION. THE TEAM PERFORMED A PERICARDIAL WINDOW TO DRAIN AND THE BLEED PERSISTED SO, TEAM LIFTED HER HEART AND THIS REVEALED THERE WAS A LARGE DEFECT IN THE LEFT ATRIUM. THE ATTEMPTED SURGICAL REPAIR AND TRANSFUSION, BUT THIS FAILED AND THE PATIENT EXPIRED. THE TEAM DID ACKNOWLEDGE THAT THE PATIENT HAD MULTIPLE ABLATIONS PRIOR TO THE EFFUSION AND LEFT ATRIUM DEFECT, WHICH COULD HAVE BEEN A CONTRIBUTING FACTOR. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE D.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387617 ↗
• DeathFeb 17, 2026Nonstandard Device; Device Damaged Prior to Receipt by User

  ON (B)(6) 2025, A 62-YEAR-OLD WOMAN ARRIVED IN CARDIOGENIC SHOCK WITH A MEASURED PH 6.99 AND A LACTATE LEVEL OF TWENTY MILLIMOLES PER LITER, INDICATING A CRITICAL CLINICAL CONDITION. DURING PREPARATION FOR PLACEMENT OF AN IMPELLA CP DEVICE FOR HEMODYNAMIC SUPPORT, IT WAS NOTED THAT THE SEALED DEVICE PACKAGING BOX CONTAINED AN INCORRECT SHEATH. SPECIFICALLY, A 23 FRENCH SHEATH INTENDED FOR RIGHT-SIDED CIRCULATORY SUPPORT WAS FOUND INSTEAD OF THE REQUIRED FEMORAL ARTERIAL SHEATH. AN ADDITIONAL PACKAGING BOX WAS OPENED TO OBTAIN THE CORRECT FEMORAL SHEATH, WHICH RESULTED IN A DELAY IN INITIATION OF DEVICE SUPPORT. THE EVENT IS BEING CONSERVATIVELY REPORTED AS A PATIENT DEATH; HOWEVER, THE PATIENT¿S UNDERLYING CRITICAL CONDITION IS BELIEVED TO BE THE MOST LIKELY CAUSE OF THE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370878 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 79-YEAR-OLD MALE PATIENT WITH ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS). THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SCAI STAGE E SHOCK. DURING SUPPORT, A PEEL AWAY SHEATH WAS INTENTIONALLY LEFT IN PLACE PER THE MANAGING PHYSICIAN, WHO HAD NO CONCERNS DUE TO THE PATIENT BEING A BILATERAL BELOW KNEE AMPUTEE. A SMALL AMOUNT OF OOZING WAS NOTED AT THE INSERTION SITE, AND THE PATIENT RECEIVED ONE UNIT OF PACKED RED BLOOD CELLS DUE TO LOW HEMOGLOBIN OF 7.5. THE DRESSING AROUND THE IMPELLA REMAINED CLEAN AND DRY, WITH NO EVIDENCE OF ACTIVE BLEEDING. THE PATIENT REMAINED STABLE AND SURVIVED TO EXPLANT. THE DEVICE WAS NOT REMOVED DUE TO THE EVENT. THERE IS NO EVIDENCE OF DEVICE PERFORMANCE ISSUES, AND THE PUMP FUNCTIONED AS EXPECTED THROUGHOUT SUPPORT. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS. BLEEDING IS LISTED AS A POTENTIAL ADVERSE EVENT FOR IMPELLA CP AND IS CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24300263 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP WAS INSERTED VIA LEFT FEMORAL ARTERY IN A 62 YEAR OLD FEMALE WHO WAS ADMITTED FOR HIGH RISK PERCUTANEOUS CORONARY INTERVENTION. THE PATIENT¿S COMORBIDITIES WERE CORONARY ARTERY DISEASE AND DIABETES MELLITUS. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE C. THE PATIENT RECEIVED SUPPORT WITH THE CP FOR THE CORONARY ANGIOPLASTY. AT THE END OF THE PROCEDURE, THE CP WAS EXPLANTED AND LEFT FEMORAL SITE WAS CLOSED WITH PERCLOSE X2. AN ANGIOGRAM REVEALED A LESION AT THE LEFT FEMORAL ACCESS SITE REQUIRING BALLOON ANGIOPLASTY OF LEFT SUPERFICIAL FEMORAL ARTERY. BALLOONING WAS SUCCESSFUL WITH DISTAL RUNOFF. BLEEDING AND VASCULAR INJURY ARE KNOWN POTENTIAL ADVERSE EVENTS OF THE IMPELLA CP PER THE INSTRUCTIONS FOR USE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24294712 ↗
• MalfunctionFeb 9, 2026Failure to Advance; Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING IMPLANT, A LONG SHEATH WAS UTILIZED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE IMPELLA UP THE DESCENDING AORTA AND WAS UNABLE. THE SHEATH KINKED. AN AORTOGRAM WAS PERFORMED, SHOWING PLAQUE BURDEN IN DESCENDING WHERE THE IMPELLA WAS GETTING STUCK. NO ISSUES PUTTING PIGTAIL AND WIRE IN (LEFT VENTRICLE) LV PRIOR TO THE IMPELLA. DECISION MADE TO ABORT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K222113. One submission often covers many models, so check the product and lot details in each record.

• Z-2128-2023 · May 26, 2023 · Open, Classified
  Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457