Impella 0052-3005Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04260113630303), received between Aug 22, 2025 and Sep 30, 2026 — classified as 1 death, 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (13 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Deformation Due to Compressive Stress; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948502 ↗
• MalfunctionSep 22, 2026Deformation Due to Compressive Stress

  It was reported that the tip of the guidewire was deformed when it was opened, and it could not be used. There was no reported delay in the procedure. Another guidewire was used immediately after the package was opened to complete the procedure. The patient survived the procedure with no patient harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853803 ↗
• MalfunctionSep 17, 2026Failure to Advance; Deformation Due to Compressive Stress

  Clinical Narrative: US.An Impella CP with SmartAssist (CPSA C9) was inserted via the right femoral artery in a patient of unknown age and gender for inability to wean from cardiopulmonary bypass (CPB) following emergency coronary artery bypass grafting (CABG). The patient's comorbidities and pre-support clinical condition Society for Cardiovascular Angiography and Interventions (SCAI) stage were not reported.During the initial implantation attempt, vascular access was obtained via the right femoral artery under ultrasound guidance. The Impella was advanced over the guidewire; however, advancement was unsuccessful and the device buckled during the procedure. The device was removed due to inability to advance the guidewire/device. No access-site complication was reported. A second Impella CP was subsequently implanted via the left femoral artery under fluoroscopic guidance and was successfully advanced and positioned without further issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800973 ↗
• MalfunctionSep 2, 2026Device Damaged Prior to Receipt by User; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568852 ↗
• InjuryJul 30, 2026Difficult to Insert

  Clinical Narrative:An Impella 5.5 device was inserted via the right axillary/subclavian artery in a 69-year-old female patient for acute decompensated chronic cardiomyopathy. The patient's comorbidities included prior coronary artery bypass grafting (CABG), coronary artery disease, and renal insufficiency. The patient's clinical condition prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Stage D shock.During the implant procedure, while preparing the Impella 5.5 for advancement, the guidewire was inadvertently passed through the side of the Impella inflow cage rather than through the center of the inflow cage as intended. Resistance was encountered while crossing the aortic valve. As the physician attempted to advance the device through the graft and across the aortic valve, continued resistance was noted, and difficulty steering and advancing the device was reported. The physician was initially unaware of the guidewire position and, after multiple unsuccessful advancement attempts, became concerned that the Impella motor or catheter may have been compromised. The implant procedure was subsequently aborted, and a replacement Impella

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50082413 ↗
• InjuryJul 27, 2026Failure to Advance

  An Impella 5.5 device was inserted into the right axillary/subclavian artery in a 64-year-old male patient in Society for Cardiovascular Angiography & Interventions (SCAI) stage E shock, on multiple inotropes/vasopressors, and on a ventilator for respiratory support, prior to initiation of support. The Impella was inserted for a high-risk cardiothoracic surgery: coronary artery bypass surgery (CABG) and mitral valve repair/replacement. The Impella was inserted as an escalation of therapy from an Impella CP. The patient's comorbidities are unknown.While in the operating room (OR), a graft was sewn to the right axillary artery with plans to place the pump at the end of the case upon separation from bypass. Multiple attempts were made under echocardiogram and fluoroscopy guidance to insert the device. Over-the-wire technique (not listed per Instructions for Use) was also attempted as wireless approach without success. Insertion was made into the ascending aorta, but met with significant resistance when trying to advance the pump. The physician decided to abort pump placement due to concern of damage to the inlet. It was noted that the vessels were tortuous.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045921 ↗
• MalfunctionMay 4, 2026Device Damaged Prior to Receipt by User; Failure to Advance; Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED THAT THEIR .018 GUIDEWIRE KINKED AND WAS DAMAGED COMING OUT OF PACKAGE. THEY REPORTED THEY HAD TO OPEN ANOTHER .018 OUT OF A DIFFERENT IMPELLA BOX. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073383 ↗
• MalfunctionApr 29, 2026Malposition of Device

  IT WAS REPORTED THAT IMPLANTING AN IMPELLA 5.5 WAS DIFFICULT DUE TO PATIENT ANATOMY. MULTIPLE WIRES WERE USED TO ATTEMPT IMPLANTATION BUT WERE UNSUCCESSFUL. AN IMPELLA CP WAS IMPLANTED INSTEAD. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028302 ↗
• MalfunctionApr 20, 2026Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED A PATIENT ON IMPELLA SUPPORT WITH A CP PUMP. THE COMPLAINANT REPORTED THE FOLLOWING: SHORT IMPELLA SHEET INSERTED PIGTAIL CRUST, AORTIC VALVE AND A LEFT VENTRICLE IMPELLA ON A WIRE INSERTED CATHETER REMOVED IMPELLA CP INSERTED ON WIRE IN, ADVANCED THROUGH THE ILIAC, WHERE THE PHYSICIAN HAD TO PUSH A LITTLE BIT IT CONTINUED UP UNTIL THE DESCENDING AORTIC ARCH WHERE THE PHYSICIAN MET EXTREME RESISTANCE, ENDED UP VISUALIZING THE END OF THE SHEATH AND SAW THE WIRE AND CATHETER BUCKLING. STAFF THEN STOPPED REMOVE THE IMPELLER FROM THE SHORT IMPELLER SHEATH, FLUSH THE CATHETER AND PREPARED IT FOR REINSERTION AND THEN THE LONG IMPELLA 14 FRENCH SHEET WAS INSERTED PIGTAIL ADVANCED CROSS THE AORTIC VALVE AGAIN THIS TIME WITH A V8 WIRE. THE IMPELLA WAS THEN RE-ADVANCED TO THE SHEATH IN ADVANCED NO ISSUES THROUGH THE ILIAC ARTERY, BUT THEN WHEN IT GOT BACK TO THE DESCENDING ARCH, HAD DIFFICULTIES CROSSING AS WELL LOST WIRE IN THE LEFT VENTRICLE. THEN EXPLAINED THE IMPELLA REF FLUSHED THE DEVICE AGAIN AND THEN WE ATTEMPTED WITH A THIRD TIME WITH A THIRD NEW WIRE AND WE INSERTED THE IMPALA AND BROUGHT IT JUST DISTAL TO WHERE WE WERE HAVING ISSUES IN THE ARCH. STAFF THEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933686 ↗
• MalfunctionApr 15, 2026Difficult to Advance

  AN IMPELLA CP WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 74-YEAR-OLD MALE PATIENT FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E SHOCK. DURING IMPLANTATION, DIFFICULTY CROSSING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) VALVE WITH THE PIGTAIL AND 0.018-INCH GUIDEWIRE WAS REPORTED. DESPITE THIS, THE IMPELLA CP WAS SUCCESSFULLY ADVANCED OVER THE WIRE WITHOUT ISSUE, AND THE PUMP INITIALLY FUNCTIONED WITHOUT CONCERNS. DURING A SUBSEQUENT PEEL-AWAY SHEATH EXCHANGE PERFORMED BY THE PHYSICIAN AND SCRUB TEAM, THE PUMP WAS OBSERVED TO BE PULLED BACKWARDS. ATTEMPTS TO RE-ADVANCE THE DEVICE INTO THE LEFT VENTRICLE (LV) WERE UNSUCCESSFUL DUE TO A KINK IDENTIFIED IN THE CANNULA JUST BELOW THE MOTOR HOUSING. AT THAT TIME, FLOWS WERE REDUCED TO APPROXIMATELY 2.1 L/MIN. BASED ON THESE FINDINGS, THE CLINICAL TEAM ELECTED TO REMOVE THE AFFECTED IMPELLA CP AND REPLACE IT WITH A NEW IMPELLA CP. NO ADVERSE EVENTS WERE REPORTED WITH THE SECOND IMPELLA CP. THE PATIENT ULTIMATELY EXPIRED. THE SURVIVAL OUTCOME WAS DEATH, WHICH IS BEING CONSERVATIVELY REPORTED AND CODED TO THE FIRST IMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889791 ↗
• InjuryApr 8, 2026Difficult to Remove; Difficult to Advance; Patient Device Interaction Problem

  CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 85-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND A PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT'S UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE TEAM PLACED THE CP INTO THE LEFT VENTRICLE VIA THE .018 GUIDEWIRE AS STANDARD PRACTICE BUT, HAD DIFFICULTY REMOVING THE WIRE. THE TEAM HAD A "STUCK" FEELING. THE TEAM DID PROCEED WITH THE SUPPORT BUT, FOUND THERE WAS SUCTION AND LOW FLOWS DESPITE ALL STANDARD TROUBLESHOOTING BY GIVING VOLUME. UPON INVESTIGATION BY THE PHYSICIAN THE TEAM OBSERVED THERE WAS A PERFORATION OF THE LEFT VENTRICLE. THE TEAM EMERGENTLY REPAIRED THE VENTRICLE AND REPLACED THE AORTIC VALVE. THE TEAM RELAYED THAT THE TEAM HAD SOME DIFFICULTY CROSSING THE VALVE, BUT BEYOND THAT GAVE NO DETAILS ON HOW/WHEN THE PERFORATION OCCURRED. THE PATIENT SURVIVED THE UNPLANNED SURGERY AND PUMP EXPLANT.

  Patient problems: Cardiac Perforation

  MAUDE report 24818588 ↗
• MalfunctionApr 8, 2026Failure to Advance

  IT WAS REPORTED THAT IMPLANTATION OF AN IMPELLA 5.5 WAS ABORTED DUE TO PATIENT ANATOMY. THE WIRE AND PIGTAIL CATHETER COULD NOT REACH THE ATRIAL VALVE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815412 ↗
• MalfunctionMar 30, 2026Deformation Due to Compressive Stress

  CLINICAL NARRATIVE: AN 81-YEAR-OLD MALE WITH AN INDICATION FOR USE OF POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS), PRESENTING IN A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE E, UNDERWENT AN ATTEMPTED IMPELLA CP IMPLANT VIA PERCUTANEOUS LEFT FEMORAL ARTERIAL ACCESS ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN ELECTED TO USE A MEDTRONIC SENTRANT SHEATH, STATING A PREFERENCE TO AVOID BLEEDING ASSOCIATED WITH REPOSITIONING SHEATHS. WHILE ADVANCING THE IMPELLA CP CATHETER OVER A GUIDEWIRE INTO THE SENTRANT SHEATH AT AN APPROXIMATE 45° INSERTION ANGLE, RESISTANCE WAS ENCOUNTERED WITHIN THE SHEATH. EXCESSIVE FORCE WAS APPLIED IN AN ATTEMPT TO ADVANCE THE DEVICE, AT WHICH TIME THE CATHETER BECAME STUCK WITHIN THE SHEATH. AS A RESULT, THE IMPELLA CATHETER SHAFT AND GUIDEWIRE KINKED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT, AND NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS ABORTED, AND THE DECISION WAS MADE TO IMPLANT A SECOND IMPELLA CP. CARE WAS WITHDRAWN FROM THE SECOND CP AND THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2026. PRODUCT DAMAGE WAS IDENTIFIED AS CATHETER KINKING, AND BOTH THE PUMP AND INTRODUCER WERE REQUESTED FOR RETURN. NO ISSUES WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713228 ↗
• MalfunctionMar 26, 2026Difficult to Remove

  AN IMPELLA CP DEVICE WAS ATTEMPTED VIA THE RIGHT FEMORAL ARTERY IN A PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE PATIENT¿S CURRENT STATUS IS REPORTED AS STABLE. ACCORDING TO THE PHYSICIAN, THE INSERTION EVENT WAS RELATED TO THE EQUIPMENT BECAUSE THE IMPELLA CP WAS ADVANCED INTO THE LEFT VENTRICLE, BUT THE 0.018-INCH WIRE COULD NOT BE WITHDRAWN FROM THE DEVICE. THE PUMP WAS THEREFORE REMOVED BECAUSE THE WIRE COULD NOT BE EXTRACTED. NON-OPERATIONAL LOG DATA COULD NOT BE PROVIDED. THE PATIENT DID NOT HAVE A KNOWN HISTORY OF VASCULAR DISEASE SUCH AS PERIPHERAL VASCULAR DISEASE OR AORTIC STENOSIS, AND THERE WAS NO NOTED VESSEL FLEXION THAT WOULD HAVE MADE INSERTION DIFFICULT. IMAGING WAS USED TO EVALUATE THE VESSEL DIAMETER PRIOR TO THE PROCEDURE. THE TEAM WAS ABLE TO ADVANCE THE DEVICE TO THE LEFT VENTRICLE, BUT THE 0.018-INCH WIRE COULD NOT BE REMOVED AND THE DEVICE COULD NOT BE OPERATED. THE DEPLOYMENT SHEATH DID PULL TO THE CATHETER PLUG, AND THE WIRE TIP WAS SHAPED. NO SPECIFIC POINT OF RESISTANCE WAS IDENTIFIED. THE PATIENT HAD NO KNOWN HISTORY OF PERIPHERAL ARTERY DISEASE, AND NO DIFFICULTIES WERE ENCOUNTERED WHEN INSERTING THE PLACEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707125 ↗
• MalfunctionMar 22, 2026Failure to Advance

  A 75-YEAR-OLD FEMALE PATIENT WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS) UNDERWENT ATTEMPTED IMPELLA SUPPORT. BASED ON THE LIMITED PROCEDURAL INFORMATION AVAILABLE, IT IS ASSUMED THAT THE PATIENT WAS ALREADY RECEIVING ECMO SUPPORT AT THE TIME OF THE ATTEMPT. DURING ADVANCEMENT OF THE GUIDEWIRE TOWARD THE LEFT VENTRICLE, THE AORTIC VALVE WAS NOT OPENING, WHICH PREVENTED SUCCESSFUL WIRE PASSAGE AND DEVICE INSERTION. AS A RESULT, IMPELLA SUPPORT COULD NOT BE INITIATED.

  Patient problems: Hemodynamic instability

  MAUDE report 24658908 ↗
• MalfunctionMar 15, 2026Difficult to Insert; Difficult to Remove

  AN 84 YEAR OLD FEMALE WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH A PERCUTANEOUS CORONARY INTERVENTION TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY EARLIER ON THE SAME DAY DEVELOPED DE NOVO CHEST PAIN AND ST SEGMENT ELEVATIONS, REQUIRING RE-EVALUATION IN THE CATHETERIZATION LABORATORY. PLACEMENT OF AN IMPELLA CP WAS PLANNED. WHILE IMPELLA WAS BEING PREPARED FOR PURGING AND CONNECTION TO THE CONTROLLER, DURING PREPARATION OF THE PURGE SOLUTION AND PURGE CASSETTE A "PURGE SYSTEM FAILURE" ALARM OCCURRED. PREPARATION WAS CONTINUED DESPITE THE ALARM AND THE ALARM EVENTUALLY DISAPPEARED DURING NEXT STEPS. THE IMPELLA WAS THEN DELIVERED INTO THE LEFT VENTRICLE BUT THE WIRE BECAME STUCK WHEN TRYING TO REMOVE IT FROM THE PUMP. THE SYSTEM IN ITS ENTIRETY WAS REMOVED WITHOUT CONSEQUENCES TO THE PATIENT AND THE IMPELLA WAS THEN REPLACED WITH A NEW CP THAT COULD BE DELIVERED WITHOUT ISSUES. THE PERCUTANEOUS INTERVENTION WAS CARRIED OUT AND THE NEW DEVICE WEANED AND REMOVED SUCCESSFULLY AFTER THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601592 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 51-YEAR-OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH CORONARY ARTERY DISEASE, AND A PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE INTRODUCER WAS NOT THE ABIOMED PROVIDED, BUT RATHER ACCESS WAS MADE WITH A COOK 14FR INTRODUCER SHEATH. THE PATIENT'S UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE .018 GUIDEWIRE WAS INSERTED TO THE LEFT VENTRICLE AND THE PATIENT SUFFERED FROM VENTRICULAR FIBRILLATION. CPR WAS BEGUN AND THE CP PUMP WAS ADVANCED TO THE VENTRICLE. THE CPR WAS ONGOING FOR 55 MINUTES AND THEY ADDED EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) AND PROCEEDED WITH THE ANGIOPLASTY OF THE 2 CORONARY ARTERIES. THE PATIENT WAS GIVEN 2 UNITS OF BLOOD. THE LEG ACCESSED BY THE CP PUMP WAS ISCHEMIC AND THEY USED THE ECMO CIRCUIT TO ALLOW FOR LEG REPERFUSION. OF NOTE THE LEGS WERE BILATERALLY SHOWING SIGNS OF ISCHEMIA, INCLUSIVE OF PALLOR/COLOR CHANGE. AFTER 3 DAYS THE PUMP WAS EXPLANTED AND ESCALATED TO THE AXILLARY ACCESSED 5.5 PUMP. THE PATIENT SURVIVED THE HARMS AND OF NOTE THE COOK SHEATH AND ECMO COULD HAVE CAUSED/CONTRIBUTED TO THE HARM. ISCHEMIA MAY BE INFLUENCED

  Patient problems: Ischemia; Ventricular Fibrillation

  MAUDE report 24587300 ↗
• MalfunctionMar 4, 2026Difficult to Insert; Difficult to Remove; Device Damaged by Another Device

  A 70 -YEAR-OLD MALE PATIENT PRESENTED WITH POST CARDIOTOMY CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES ARE UNKNOWN. CLINICAL ASSESSMENT PRIOR TO INITIATION OF MECHANICAL CIRCULATORY SUPPORT IDENTIFIED THE PATIENT AS SCAI SHOCK STAGE C WITH ECMO SUPPORT. THE PATIENT WAS STATUS POST DESCENDING ARTERY REPLACEMENT SURGERY ON FEBRUARY 13TH WHO BECAME ILL AND WAS SUBSEQUENTLY PLACED ON ECMO ON FEBRUARY 15TH, AFTER WHICH IMPELLA WAS ALSO INTRODUCED. THE IMPELLA CP 10 ATTEMPTED TO BE INSERTED THROUGH THE 14FR LOW PROFILE SHEATH VIA THE LEFT FEMORAL ARTERY. THE DEVICE WAS INSERTED; HOWEVER, POSITIONING WAS NOT PERFORMED PROPERLY, AND THE 0.018 WIRE HAD SLIPPED OUT OF THE MONORAIL LUMEN, THEREFORE THE DECISION WAS MADE TO REMOVE THE DEVICE. DUE TO THE WIRE NOT BEING REMOVED RESISTANCE WAS FELT NEAR THE MOTOR'S ENTRY INTO THE SHEATH, SO THE DEVICE WAS PUSHED BACK AND THE WIRE WAS REMOVED SEPARATELY. RESISTANCE WAS FELT AGAIN WHEN ATTEMPTING TO RETRACT THE DEVICE INTO THE SHEATH WITHOUT THE WIRE, THE DEVICE WAS PULLED BACK, HOWEVER, THE COILED WIRE GOT CAUGHT NEAR THE MOTOR, CAUSING THE DEVICE TO BE PULLED ALONG WITH THE WIRE. THEREFORE, IT WAS DECIDED TO REMOVE THE ENTIRE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505187 ↗
• MalfunctionMar 3, 2026Difficult to Remove; Deformation Due to Compressive Stress

  CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 75-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE C. AFTER INITIAL PLACEMENT, REMOVAL OF THE PLACEMENT WIRE RESULTED IN A CHANGE IN DEVICE POSITION. ATTEMPTS WERE MADE TO REMOVE AND REPOSITION THE DEVICE; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE WITHDRAWING THE 0.018-INCH WIRE AND THE IMPELLA. THE IMPELLA WAS ADVANCED SLIGHTLY TO SEPARATE IT FROM THE SHEATH, AND THE WIRE WAS REMOVED FIRST, FOLLOWED BY THE IMPELLA CATHETER. INSPECTION REVEALED THE WIRE SHAFT WAS KINKED. A NEW 0.018-INCH WIRE WAS THEN USED TO SUCCESSFULLY REPOSITION AND PLACE THE IMPELLA. THE PATIENT SUBSEQUENTLY EXPIRED WHILE ON SUPPORT. THE CAUSE OF DEATH WAS DOCUMENTED AS BRAIN-RELATED. PER THE PHYSICIAN, THE IMPELLA WAS OPERATING WITHOUT ISSUES; THERE WERE NO DEVICE-RELATED COMPLICATIONS, AND THE RESUSCITATION AND SUBSEQUENT DECLINE WERE ATTRIBUTED TO NON-DEVICE FACTORS CONSISTENT WITH A WORSENING BRAIN-RELATED CONDITION. THE REPORTED EVENTS INCLUDE DIFFICULTY REMOVING THROUGH OTHER DEVICE, PRODUCT DAMAGE (KINKED WIRE), MEDICAL DEVICE REMOVAL, DEV

  Patient problems: Hemodynamic instability; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497325 ↗
• DeathFeb 26, 2026Deformation Due to Compressive Stress; Material Integrity Problem

  ADDITIONAL INFORMATION HAS BEEN PROVIDED UPON REQUEST: THE DAMAGE WAS IDENTIFIED DURING THE IMPLANTATION PROCEDURE. HOWEVER, THE IMPELLA COULD BE ADVANCED WITHOUT ANY DIFFICULTIES AND WAS SUCCESSFULLY POSITIONED. YES, BOTH CALCIFICATIONS AND VESSEL KINKING WERE PRESENT. NO, I DO NOT HAVE ANY ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456933 ↗
• MalfunctionJan 13, 2026Deformation Due to Compressive Stress; Difficult to Advance

  THE COMPLAINANT REPORTED A PATIENT ON IMPELLA SUPPORT WITH A 5.5 PUMP. THE COMPLAINANT REPORTED THE 0.018 WIRE BENT WHILE ATTEMPTING TO ENTER THE LEFT VENTRICLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060326 ↗
• MalfunctionJan 9, 2026Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN IMPELLA CP IT WAS DIFFICULT FOR THE GUIDEWIRE TO CROSS THE AORIC VALVE OR INTO THE LEFT VENTRICLE. THE PUMP CAME OUT OF THE LEFT VENTRICLE INTO THE AORTIC ARCH. THE PUMP WAS REMOVED AND THE PROCESS WAS REPEATED WITH A V-18 WIRE AS THE ABIOMED WIRE HAD A SIGNIFICANT KINK IN IT. THE SECOND ATTEMPT YIELDED THE SAME RESULTS. A SECOND PUMP WAS THEN USED FOR SUCCESSFUL IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021273 ↗
• MalfunctionJan 6, 2026Difficult to Remove

  THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. PUNCTURE AND INSERTION OF THE SHEATH WERE STRAIGHTFORWARD. PLACEMENT OF THE 0.018 WIRE WAS UNCOMPLICATED. THREADING THE WIRE THROUGH THE EASY-GUIDE LUMEN AND POSITIONING OF THE IMPELLA CATHETER IN THE LEFT VENTRICLE WERE ALSO TROUBLE-FREE. HOWEVER, REMOVING THE WIRE FROM THE IMPELLA CP WAS NOT POSSIBLE. THE 0.018 WIRE COULD NOT BE WITHDRAWN FROM THE IMPELLA CP. THEREFORE, THE DECISION WAS MADE TO REMOVE THE IMPELLA CATHETER, INCLUDING THE 0.018 WIRE, FROM THE PATIENT VIA THE SHEATH AND TO IMPLANT ANOTHER IMPELLA CP WITH SMARTASSIST CATHETER. THE PATIENT IS DOING VERY WELL AFTER THE PRIMARY PERCUTANEOUS CORONARY INTERVENTION WITH THE SECOND IMPELLA CATHETER. THE PATIENT WAS ON A GENERAL WARD AND WAS SCHEDULED TO BE DISCHARGED HOME IN THE NEXT FEW DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23978309 ↗
• MalfunctionOct 16, 2025Difficult to Remove; Difficult to Remove

  THE COMPLAINANT REPORTED THAT DURING IMPELLA CP INSERTION, THE MEDICAL DOCTOR PLACED A SENTRANT SHEATH AND ACCESSED THE LEFT VENTRICLE WITH A PIGTAIL. 018 WIRE WAS THEN PLACED BUT THEY WERE UNABLE TO ADVANCE THE IMPELLA CATHETER AROUND THE AORTIC ARCH DUE TO HEAVY RESISTANCE. THE MEDICAL DOCTOR HAD TO REMOVE THE IMPELLA CP AND THE GUIDEWIRE TOGETHER. A NEW IMPELLA CP WAS PLACED SUCCESSFULLY. THIS REPORT REPRESENTS THE GUIDEWIRE. A SEPARATE REPORT WAS SUBMITTED FOR THE PUMP. REFER TO SECTION H.10 FOR THE RELATED REPORT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309828 ↗
• MalfunctionSep 4, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. WHEN INTRODUCING THE IMPELLA CP, THE 0.018 GUIDEWIRE WAS SHAPED AND ADVANCED INTO THE PIGTAIL, BUT IT DID NOT COME OUT FROM THE TIP OF THE PIGTAIL AND ENCOUNTERED STRONG RESISTANCE. UPON CHECKING THE TIP OF THE GUIDEWIRE, A BEND THAT HAD NOT BEEN MADE DURING SHAPING WAS FOUND, WHICH WAS THOUGHT TO BE THE CAUSE. THEREFORE, A NEW WIRE WAS USED, WHICH PASSED THROUGH WITHOUT ISSUE AND THE IMPELLA CP WAS SUCCESSFULLY PLACED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967255 ↗