Abiomed Impella14Fr Introducer Kit, 13cm & 25cm 0052-3046Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00813502011678), received between Jan 23, 2026 and Sep 25, 2026 — classified as 7 deaths, 22 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (11 reports).

20 other recalls cover devices cleared under the same FDA submission (K192769); 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 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Difficult to Advance

  Clinical Narrative UPDATED (b)(6)2026: Since the original report was submitted, additional clinical follow-up information has been received regarding the previously reported pump and introducer replacement event. Following replacement of both the Impella pump and introducer, the patient was successfully supported with the replacement system throughout the planned protected percutaneous coronary intervention (PCI).The replacement pump functioned as intended and provided adequate hemodynamic support for completion of the procedure. Following successful PCI, the Impella support was weaned, and the device was explanted without complication.Prior Clinical Narrative:An Impella CP was inserted percutaneously via right femoral artery access site in a 78-year-old male patient for High-Risk Percutaneous Coronary Intervention (HRPCI). The patient¿s comorbidities were coronary artery disease and femoral artery stenosis and calcification. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage A identified as hemodynamically stable patient who is not experiencing signs or symptoms of cardiogenic shock but is a risk f

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896436 ↗
• DeathSep 22, 2026Adverse Event Without Identified Device or Use Problem

  An Impella CP was inserted percutaneously via left femoral artery access site in 74-year-old female patient for Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities were coronary artery disease, hematoma and obesity. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage E identified as the body fails to respond to maximal lifesaving therapies. The patient was receiving inotropes, vasopressors and respiratory support.During support, the patient developed left lower limb ischemia, identified by loss of Doppler signals and absent pulses in the left leg. Angiographic evaluation of the left groin demonstrated no flow distal to the Impella sheath. Due to the patient's preexisting hematoma and obesity, the physician elected to leave the device in the peel-away sheath and manage conservatively, including angiography and weaning of vasopressor support with planned reassessment. High-dose vasopressor therapy was identified as an additional contributing factor. The ischemia did not resolve, and the device was not removed due to the reported event. The patient subsequently underwent withdraw

  Patient problems: Ischemia

  MAUDE report 50855402 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Impella CP SmartAssist was inserted via right femoral artery access site in a 55-year-old male patient presenting with Acute Myocardial Infarction and Cardiogenic Shock. The patient¿s comorbidities were peripheral arterial disease. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage B. Stage B patients have clinical evidence of hypoperfusion that initially requires pharmacological or mechanical support. Hypotension is usually present. Prior to the Impella placement the patient was on respiratory support.Following femoral insertion of the Impella CP SmartAssist, the medical team observed signs of limb ischemia in the accessed extremity, including a cold foot. Due to concerns for ischemia, the Impella CP SmartAssist was explanted after approximately 12 hours of support and therapy was escalated to an axillary artery inserted Impella 5.5 SmartAssist.During support with the Impella CP SmartAssist, the patient was also noted to have signs consistent with hemolysis. Urine discoloration was observed and plasma free hemoglobin levels were reported to be elevated. After transition to the Impella 5.5 Smar

  Patient problems: Hemolysis; Ischemia

  MAUDE report 50808096 ↗
• DeathJun 9, 2026Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 84-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE PATIENT¿S MEDICAL HISTORY WAS NOTABLE FOR PERIPHERAL ARTERIAL DISEASE AND PERIPHERAL VASCULAR DISEASE. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) SHOCK STAGE C. ACCESS WAS OBTAINED USING MICROPUNCTURE TECHNIQUE WITH ULTRASOUND AND FEMORAL ANGIOGRAPHY GUIDANCE. DUE TO SIGNIFICANT PERIPHERAL ARTERIAL DISEASE, SHOCKWAVE LITHOTRIPSY WAS UTILIZED ON THE ILIAC ARTERY AND AORTA. A 25 CENTIMETER IMPELLA SHEATH WAS PLACED WITHOUT DIFFICULTY, AND THE IMPELLA CP DEVICE WAS SUCCESSFULLY INSERTED. FOLLOWING PERCUTANEOUS CORONARY INTERVENTION, THE PEEL-AWAY SHEATH WAS REMOVED AND A REPOSITIONING SHEATH WAS ADVANCED. FEMORAL ANGIOGRAPHY DEMONSTRATED ABSENCE OF DISTAL FLOW BEYOND THE IMPELLA SHEATH. A 6 FRENCH RIGHT FEMORAL ANTEGRADE SHEATH AND A 6 FRENCH LEFT FEMORAL RETROGRADE SHEATH WERE PLACED, AND THE SIDE PORTS WERE CONNECTED TO ESTABLISH FLOW TO THE RIGHT LOWER EXTREMITY. ANGIOGRAPHY CONFIRMED RESTORATION OF FLOW TO BOTH LOWER EXTREMI

  Patient problems: Ischemia

  MAUDE report 25445320 ↗
• DeathMay 27, 2026Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 86-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT HAD A HISTORY OF KNOWN CORONARY ARTERY DISEASE. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS UNKNOWN. AFTER THE DEVICE WAS SECURED AND THE CASE FINISHED, THE PATIENT ARRIVED TO THE CATH LAB. THE PHYSICIAN LEFT THE PEEL-AWAY SHEATH IN PLACE, AND NO FLUOROSCOPIC IMAGING WAS PERFORMED FOR IMPELLA PLACEMENT OR RUNOFFS. A RIGHT PEDAL PULSE CHECK WAS REQUESTED; STAFF NOTED NO PULSES ON THE RIGHT SIDE AND FAINT PEDAL PULSES DOPPLERED ON THE LEFT SIDE. THE TEAM DISCUSSED OPTIONS WITH THE PHYSICIAN, INCLUDING REMOVING THE PEEL-AWAY SHEATH AND PLACING A REPOSITIONING SHEATH, REMOVAL, OR DISTAL PERFUSION SHEATH. THE PHYSICIAN STATED HE WANTED TO GET THE PATIENT TO THE UNIT SO FAMILY COULD SEE HER, AND BELIEVED THE PATIENT MAY TRANSITION TO HOSPICE CARE. THE PATIENT EXPIRED ON SUPPORT. LIMB ISCHEMIA MAY HAVE OCCURRED DUE TO THE PRESENCE OF THE PEEL-AWAY SHEATH LEFT IN PLACE, LACK OF FLUOROSCOPIC IMAGING TO CONFIRM DEVICE AND SHEATH POSITION, AND THE PATIENT¿S ACUTE MYOCARDIAL INFARC

  Patient problems: Ischemia

  MAUDE report 25306618 ↗
• InjuryMay 27, 2026Patient Device Interaction Problem

  A 66-YEAR-OLD MALE WITH A PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D UNDERWENT IMPELLA CP SUPPORT FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI). DURING PLACEMENT OF A 14F SHEATH VIA THE RIGHT FEMORAL ARTERY, THE OPERATOR REPORTED THAT THE SHEATH WAS INSERTED AT A HIGH ANGLE WITH EXCESSIVE FORCE. A HEMATOMA WAS NOTED AT THE ACCESS SITE SHORTLY THEREAFTER, INITIALLY PRESUMED TO BE RELATED TO PRIOR 6F SHEATH PLACEMENT FOLLOWING PERCLOSE DEPLOYMENT. THROUGHOUT THE PROCEDURE, THE HEMATOMA APPEARED TO PROGRESSIVELY ENLARGE, THOUGH VISUALIZATION WAS LIMITED BY STERILE DRAPING. FOLLOWING COMPLETION OF PCI, ATTEMPTS TO WEAN IMPELLA SUPPORT, HOWEVER THE PHYSICIAN ELECTED TO MAINTAIN MECHANICAL SUPPORT. THE 14FR PEEL AWAY SHEATH WAS REMOVED AND THE REPOSITIONING SHEATH WAS INSERTED. UPON REMOVAL OF THE STERILE DRAPES, A SIGNIFICANTLY ENLARGED ACCESS SITE HEMATOMA WAS IDENTIFIED. THE DECISION WAS MADE TO REMOVE THE IMPELLA DEVICE AND TRANSITION SUPPORT TO AN INTRA-AORTIC BALLOON PUMP (IABP) VIA THE CONTRALATERAL FEMORAL ARTERY. THE IMPELLA DEVICE WAS SUCCESSFULLY EXPLANTED, AND HEMOSTASIS WAS MANAGED WITH PERCLOSE DEPLOYMENT AND CONTRALATERAL BALLOON TAMPONADE. AN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25306466 ↗
• MalfunctionMay 15, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN IMPELLA CP RESISTANCE WAS MET IN THE ILIAC ARTERY AND THE INTRODUCER COULD NOT ADVANCE PAST THIS POINT. SHOCKWAVE WAS USED TO TREAT THE ILIAC LESION AND ALLOW FOR INSERTION OF THE SHEATH AND PUMP. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182867 ↗
• InjuryMay 8, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO IMAGING PERFORMED AT THE TIME OF THE ALARM. THE ACCOUNT DID NOT REACH OUT WHILE PREPARING TO TRANSPORT THE PATIENT; INSTEAD, A CALL WAS RECEIVED FROM CSC. THE PATIENT WAS ON ECMO AND WAS NOT REPOSITIONED PRIOR TO THE ALARM. THERE WERE NO CONCERNS WITH THE IMPELLA DESPITE THE ALARMS.

  Patient problems: Ischemia

  MAUDE report 25127404 ↗
• DeathMay 7, 2026Patient Device Interaction Problem

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 78-YEAR-OLD FEMALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), NO DISTAL PULSES WERE NOTED. AFTER ONE DAY ON SUPPORT, THE FAMILY WITHDREW CARE, AND THE PATIENT EXPIRED. THE IMPELLA FUNCTIONED AT P-5 AT 2.7 L/MIN AS INTENDED. LIMB ISCHEMIA CAN BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, ANTICOAGULATION STATUS, VASOPRESSOR SUPPORT, AND VASCULAR ACCESS CHARACTERISTICS. 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 WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, COMPLICATED BY STAGE E SHOCK.

  Patient problems: Ischemia

  MAUDE report 25110903 ↗
• InjuryMay 5, 2026Patient Device Interaction Problem

  CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE 14FR INTRODUCER AT THE FEMORAL ARTERY TO SUPPORT THE 74 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PHYSICIAN OBSERVED MINIMAL FLOW BEYOND THE 14FR BUT, MADE CHOICE TO NOT REMOVE THE PEEL AWAY SHEATH, RATHER PLACE EXTERNAL BYPASS TO PERFUSE THE LEG. THE PATIENT HAD DISTAL PULSES PRESENT WHEN THE BYPASS WAS PLACED. THE RETENTION OF THE 14FR DOES NOT FOLLOW BEST PRACTICES AS NOTED IN THE INSTRUCTIONS FOR USE. THE PUMP REMAINS ON FOR SUPPORT TO DATE WITH THE LEG PERFUSION. THE PATIENT HAS SURVIVED.

  Patient problems: Ischemia

  MAUDE report 25084642 ↗
• InjuryMay 5, 2026Difficult to Advance; Patient Device Interaction Problem

  A 72-YEAR-OLD MALE WITH A HISTORY OF CORONARY ARTERY DISEASE UNDERWENT HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH PRE-SUPPORT CLINICAL STATUS CONSISTENT WITH SCAI SHOCK STAGE D. AT THE TIME OF THE PROCEDURE, AN INTRA-AORTIC BALLOON PUMP WAS PRESENT IN THE LEFT FEMORAL ARTERY. DIAGNOSTIC ANGIOGRAPHY DEMONSTRATED VASCULAR ACCESS ABOVE THE FEMORAL BIFURCATION WITH SEVERE PERIPHERAL ARTERY DISEASE INVOLVING THE BILATERAL ILIAC ARTERIES AND A SUBTOTAL OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY; TIMI 3 FLOW WAS NOTED IN THE PROFUNDA FEMORIS, AND DOPPLER SIGNALS WERE PRESENT IN THE LEFT DORSALIS PEDIS AND POSTERIOR TIBIAL ARTERIES. THE PHYSICIAN ELECTED TO PROCEED WITH IMPELLA CP SUPPORT USING A SINGLE-ACCESS TECHNIQUE. PRE-CLOSURE WAS SUCCESSFULLY PERFORMED OVER THE PRE-EXISTING 9 FR SHEATH USING TWO PERCLOSE PROGLIDE DEVICES, AND THE ACCESS WAS UPSIZED TO A 14 FR BY 13 CM PEEL-AWAY SHEATH. INITIAL ADVANCEMENT OF THE IMPELLA CP WAS UNSUCCESSFUL DUE TO LEFT ILIAC DISEASE, REQUIRING BALLOON ANGIOPLASTY AND INTRAVASCULAR LITHOTRIPSY OF THE LEFT ILIAC ARTERY, FOLLOWED BY PLACEMENT OF A COVERED STENT FOR A DISSECTION. THE SHEATH WAS THEN EXCHANGED FOR A 14 FR BY 25 CM SHE

  Patient problems: Ischemia; Vascular Dissection

  MAUDE report 25080026 ↗
• MalfunctionApr 30, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT IMPLANTATION OF AN IMPELLA CP WAS ABORTED BECAUSE THE SHEATH APPEARED KINKED UNDER FLOUROSCOPY. A NEW IMPELLA CP PUMP WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043201 ↗
• InjuryApr 24, 2026Fluid/Blood Leak; Patient Device Interaction Problem

  CLINICAL NARRATIVE: A 39-YEAR-OLD MALE WITH A HISTORY OF CORONARY ARTERY DISEASE UNDERWENT HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH PLANNED IMPELLA SUPPORT. THE PATIENT¿S PRE-SUPPORT CLINICAL CONDITION WAS CONSISTENT WITH SCAI SHOCK STAGE A. THE IMPELLA DEVICE AND COMPANION SHEATH WERE SUCCESSFULLY PLACED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY. FOLLOWING PLACEMENT, OOZING OF BLOOD WAS OBSERVED ORIGINATING FROM THE CENTER OF THE PEEL-AWAY SHEATH. UPON EVALUATION, THE PHYSICIAN AND ON-SITE CONSULTANT DISCUSSED POTENTIAL CAUSES, WITH ATTENTION TO THE INSERTION LOCATION OF THE COMPANION SHEATH RELATIVE TO THE CENTER OF THE PEEL-AWAY VALVE; THE NEEDLE STICK WAS LATER NOTED TO BE NEAR THE CENTER OF THE VALVE AT APPROXIMATELY THE 2 O¿CLOCK POSITION WITH AN ESTIMATED INSERTION ANGLE OF 45 DEGREES. NO EXCESSIVE FORCE WAS APPLIED, AND NO VESSEL ABNORMALITIES WERE REPORTED. TO ADDRESS THE ISSUE, THE COMPANION SHEATH WAS REMOVED AND ADDITIONAL FEMORAL ARTERIAL ACCESS WAS OBTAINED IN THE CONTRALATERAL FEMORAL ARTERY. THE OOZING RESOLVED FOLLOWING THIS INTERVENTION, AND THE PROCEDURE CONTINUED WITHOUT FURTHER INTERRUPTION. THE IMPELLA DEVICE FUNCTIONED AS INTENDED AND WAS S

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24981489 ↗
• DeathApr 24, 2026Patient Device Interaction Problem

  CLINICAL NARRATIVE:AN 86-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, WITH A PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE E, PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2026 FOLLOWING CARDIAC ARREST WITH RETURN OF SPONTANEOUS CIRCULATION. THE CARE TEAM ELECTED TO PROCEED TO THE CARDIAC CATHETERIZATION LABORATORY FOR A LEFT HEART CATHETERIZATION WITH PLANNED IMPELLA CP SUPPORT. PERCUTANEOUS ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY, AND A 14 FR X 13 CM PEEL AWAY SHEATH WAS INSERTED. DURING ACCESS, THE PATIENT EXPERIENCED RECURRENT CARDIAC ARREST. MULTIPLE ROUNDS OF ADVANCED CARDIAC LIFE SUPPORT WERE PERFORMED WITHOUT SUSTAINED RECOVERY, AND THE PATIENT¿S FAMILY ELECTED TO WITHDRAW CARE. AS A RESULT, THE IMPELLA CP DEVICE WAS NOT OPENED OR IMPLANTED DUE TO THE ONGOING ARREST AND RESUSCITATION EFFORTS. THE PATIENT EXPIRED. THERE WERE NO ALLEGATIONS OF DEVICE MALFUNCTION OR PERFORMANCE ISSUES. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA CP BUT IS UNLIKELY RELATED BECAUSE IT WAS NOT INSERTED, HAVING AN ACTIVE ARREST IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAG

  Patient problems: Cardiac Arrest

  MAUDE report 24979970 ↗
• MalfunctionApr 24, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN IMPELLA PUMP A GORE SHEATH WAS USED TO ASSIST AS THE PROVIDED SHEATH WAS NOT LONG ENOUGH. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979677 ↗
• MalfunctionApr 24, 2026Fluid/Blood Leak

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 54-YEAR-OLD FEMALE PATIENT FOR CARDIOMYOPATHY. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE C. DURING SINGLE ACCESS PERCUTANEOUS CORONARY INTERVENTION (PCI), BLOOD WAS OBSERVED COMING FROM BETWEEN THE ORANGE PIECE THAT HOLDS THE HEMOSTATIC VALVE AND WHERE THE ORANGE PIECE CONNECTS TO THE PEEL-AWAY SHEATH. MANUAL PRESSURE WAS HELD ON THE SHEATH TO STOP THE BLEEDING, AND PCI WAS COMPLETED. THE PEEL-AWAY SHEATH WAS REMOVED AND A REPOSITIONING SHEATH WAS PUT IN PLACE. HOWEVER, DUE TO CONTINUED BLEEDING FROM AROUND THE REPOSITIONING SHEATH AFTER MULTIPLE ATTEMPTS TO ANGLE-MATCH THE DRESSING, MANUAL PRESSURE WAS AGAIN HELD. A FEMSTOP WAS APPLIED, AND THE PHYSICIAN ELECTED TO WEAN AND REMOVE THE PUMP AFTER ABOUT 4 HOURS IN THE ICU. THE PUMP WAS WEANED AND REMOVED SUCCESSFULLY, AND HEMOSTASIS WAS ACHIEVED WITH TWO PRE-CLOSE PROGLIDE SUTURES. THE PATIENT WAS HEMODYNAMICALLY STABLE UPON RETURN TO THE UNIT AND SURVIVED TO EXPLANT. MAJOR BLEED MAY BE RELATED TO ACCESS-SITE COMPLICATIONS AND THE ANTICOAGULATION AND PUR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24979449 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP DEVICE WAS INSERTED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY IN A 66-YEAR-OLD MALE PATIENT FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) IN THE SETTING OF SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D CARDIOGENIC SHOCK. WHILE THE PEEL-AWAY SHEATH REMAINED IN PLACE, A HEMATOMA DEVELOPED AT THE RIGHT FEMORAL ACCESS SITE. FOLLOWING REMOVAL OF THE PEEL-AWAY SHEATH AND ADVANCEMENT OF A REPOSITIONING SHEATH, PERSISTENT OOZING WAS NOTED, AND THE HEMATOMA CONTINUED TO ENLARGE. DUE TO PROGRESSIVE ACCESS-SITE BLEEDING, DR. HARRISON ELECTED TO REMOVE THE IMPELLA CP DEVICE. A 14-FRENCH GORE DRYSEAL SHEATH WAS PLACED, AND AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED TO SUPPORT THE PATIENT¿S HEMODYNAMIC NEEDS. THE REPORTED ACCESS-SITE BLEEDING AND HEMATOMA ARE CONSISTENT WITH KNOWN COMPLICATIONS ASSOCIATED WITH LARGE-BORE FEMORAL ARTERIAL ACCESS AND THE ANTICOAGULATION REQUIREMENTS OF IMPELLA SUPPORT, AND MAY BE INFLUENCED BY PATIENT-SPECIFIC AND PROCEDURAL FACTORS.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24939350 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 73-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), WITH A HISTORY OF DIABETES MELLITUS. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE E. DURING SUPPORT, ISCHEMIA DEVELOPED IN THE ACCESSED LEG. THE PEEL-AWAY SHEATH WAS REMOVED AND A REPOSITIONING SHEATH WAS INSERTED WITHOUT DIFFICULTY, WITH TWO PRECLOSE DEVICES PLACED OVER A 6 F SHEATH. ABSENT PULSES REQUIRED REPERFUSION WITH CONTRALATERAL SHEATHS. THE PATIENT REMAINED ON SUPPORT. THE ISCHEMIA MAY BE DUE TO ACCESS-SITE VASCULAR COMPROMISE IN THE SETTING OF LARGE-BORE FEMORAL ARTERIAL CANNULATION AND UNDERLYING CRITICAL ILLNESS.

  Patient problems: Ischemia

  MAUDE report 24885234 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL NARRATIVE: AN IMPELLA CP WAS TO BE INSERTED VIA THE 14FR INTRODUCER AT THE FEMORAL ARTERY TO SUPPORT THE (B)(6) YEAR OLD MALE PATIENT. THE PATIENT WAS ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE 14FR SHEATH WAS INSERTED AS WAS THE .018 GUIDEWIRE, BUT NOT THE CP PUMP. THE PATIENT WAS COMBATIVE AND RESTLESS. THIS MOVEMENT CONTRIBUTED TO THE PATIENT DEVELOPING A HEMATOMA. THE PHYSICIAN MADE DECISION TO ABORT THE CP PUMP PLACEMENT. PRODUCT WAS EXPLANTED AND MANUAL PRESSURE APPLIED FOR HEMOSTASIS. PATIENT SURVIVED ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING.

  Patient problems: Hematoma

  MAUDE report 24817102 ↗
• InjuryApr 3, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 56-YEAR-OLD MALE 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 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 BAILOUT OF A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THERE WAS BLEEDING AT THE DIAPHRAGM OF THE 14FR SHEATH. IT IS UNKNOWN IF TREATMENT WAS REQUIRED. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS A DROP IN HEMOGLOBIN REQUIRING BLOOD TRANSFUSIONS. THE PATIENT RECEIVED MULTIPLE BLOOD PRODUCTS AND ALBUMIN TO ASSIST WITH VOLUME RESUSCITATION. IT WAS REPORTED THAT THE PHYSICIAN DID NOT ATTRIBUTE THE EVENT TO THE IMPELLA. TWO DAYS AFTER IMPELLA INSERTION, THE DEVICE WAS SUCCESSFULLY REMOVED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-3 AT 1.8L/MIN AS INTENDED. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24775630 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 81-YEAR-OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH THE INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THE PATIENT WAS SUPPORTED BY INOTROPES, VASOPRESSORS, AND OXYGEN FOR RESPIRATORY NEEDS PRIOR TO THE PUMP PLACEMENT. OTHER MEDICAL HISTORY WAS NOT SHARED. ON THE DAY OF IMPLANT THE TEAM OBSERVED NO FLOW BEYOND THE IMPELLA SHEATH AND AS SUCH THE TEAM PLACED AN ANTEGRADE AND CONTRALATERAL SHEATH TO ALLOW FOR LIMB PERFUSION. DESPITE THE PERFUSION AND HEMODYNAMIC SUPPORT, AFTER 68 HOURS OF SUPPORT THE CP WAS EXPLANTED AND ESCALATED TO THE IMPELLA 5.5 WHICH WAS INSERTED VIA AXILLARY ARTERY. ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS. THE PATIENT SURVIVED THE HARM OF ISCHEMIA AN DOES REMAIN ON THE 5.5 PUMP TO DATE.

  Patient problems: Ischemia

  MAUDE report 24740533 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A 41-YEAR-OLD MALE WITH AN UNKNOWN MEDICAL HISTORY UNDERWENT PERCUTANEOUS IMPLANTATION OF AN IMPELLA CP DEVICE VIA THE LEFT FEMORAL ARTERY FOR TEMPORARY MECHANICAL CIRCULATORY SUPPORT. THE INDICATION FOR USE WAS CARDIOGENIC SHOCK SECONDARY TO AN ACUTE MYOCARDIAL INFARCTION. AT THE TIME OF IMPELLA INITIATION, THE PATIENT WAS CLASSIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE C CARDIOGENIC SHOCK. DURING VASCULAR ACCESS MANAGEMENT, THE PHYSICIAN PERFORMED PRE-CLOSURE USING PERCLOSE DEVICES. ONE PERCLOSE DEVICE WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE SECOND PERCLOSE DEVICE BECAME STUCK. THE INITIAL ARTERIAL ACCESS WAS NOTED TO BE IN THE PROFUNDA FEMORIS ARTERY. IMAGING DEMONSTRATED VASCULAR PERFORATION WITH CONTRAST EXTRAVASATION IN THE GROIN. BALLOON TAMPONADE WAS ATTEMPTED VIA CONTRALATERAL ACCESS, FOLLOWED BY PLACEMENT OF TWO COVERED STENTS IN THE PROFUNDA FEMORIS ARTERY JUST DISTAL TO THE BIFURCATION. A VASCULAR SURGEON WAS CONSULTED FOR EVALUATION, AND THE ACCESS SITE WAS STABILIZED. A HEMATOMA SUBSEQUENTLY DEVELOPED, AND ONE UNIT OF PACKED RED BLOOD CELLS WAS TRANSFUSED BASED ON OBSERVED BLOOD LOSS AND HEMODYNAMIC ASSESSMENT. THE IMPELLA SHEATHS W

  Patient problems: Perforation of Vessels

  MAUDE report 24724820 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  THE COMPLAINANT REPORTED THAT AN IMPELLA PUMP WAS IMPLANTED VIA PERCUTANEOUS RIGHT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. OOZING WAS NOTED FROM THE HEMASTATIC VALVE OF THE COMPANION SHEATH AFTER INITIAL PLACEMENT. THE MEDICAL DOCTOR ELECTED TO EXCHANGE FOR A NEW COMPANION SHEATH. THE OLD COMPANION SHEATH WAS SAVED. THE PROCEDURE WAS SUCCESSFUL WITH THE OTHER DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712778 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 79-YEAR-OLD MALE PATIENT PRESENTING FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI), SCAI SHOCK STAGE B, WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE. DURING PCI, A HEMATOMA DEVELOPED AROUND THE PEEL-AWAY SHEATH IN THE LEFT GROIN, APPROXIMATELY THE SIZE OF A GRAPEFRUIT. MANUAL PRESSURE WAS APPLIED AND THE HEMATOMA WAS MASSAGED, BUT BLEEDING CONTINUED. THE PATIENT RECEIVED FOUR UNITS OF BLOOD. THE DEVICE WAS REMOVED DURING A VASCULAR CUTDOWN, AND THE FEMORAL ARTERY WAS SUCCESSFULLY CLOSED. A NEW IMPELLA DEVICE WAS PLACED ON THE RIGHT SIDE. CARE WAS LATER WITHDRAWN, AND THE PATIENT EXPIRED. THE REPORTED HEMATOMA AND BLEEDING IS CONSISTENT WITH ACCESS-SITE COMPLICATIONS AND THE ANTICOAGULATION/PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTABLE TO THE PATIENT¿S UNDERLYING CRITICAL CONDITION.

  Patient problems: Hematoma; Hemodynamic instability; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24712416 ↗
• DeathMar 24, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 87-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE C 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). DURING THE PROCEDURE, THE PEEL-AWAY SHEATH WAS LEFT IN PLACE BY THE PHYSICIAN. A RUN-OFF ANGIOGRAM WAS PERFORMED PRIOR TO LEAVING THE CATH LAB TO CONFIRM FLOW TO THE RIGHT LOWER EXTREMITY. THE PATIENT DID NOT HAVE LEG ISCHEMIA AS THE PATIENT HAD A DISTAL PERFUSION CATHETER THAT WAS PLACED PROPHYLACTICALLY TO MITIGATE LIMB ISCHEMIA DUE TO THE PEEL-AWAY SHEATH BEING LEFT IN PLACE. A STABLE HEMATOMA WAS NOTED AT THE ACCESS SITE. SIX DAYS AFTER IMPELLA INSERTION, THE FAMILY WITHDREW CARE, AND THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-4 AT 2.6L/MIN AS INTENDED. BLEEDING (HEMATOMA) IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS. THE DEATH IS CONSERVATIVELY BEING REPORT

  Patient problems: Hematoma; Ischemia

  MAUDE report 24679890 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192769. One submission often covers many models, so check the product and lot details in each record.

• Z-2690-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
• Z-2682-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
• Z-2684-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
• Z-2689-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
• Z-2686-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and acces
• Z-2687-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
• Z-2692-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
• Z-2693-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
• Z-2691-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
• Z-2681-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
• Z-2685-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and acces
• Z-2683-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump an
• Z-2688-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
• Z-0652-2024 · Nov 7, 2023 · Open, Classified
  Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body.
• Z-0650-2024 · Nov 7, 2023 · Open, Classified
  Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052

…and 5 more.