Impella Impella 2.5 AIC Pump SetRecalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 00813502011081), received between Jul 29, 2016 and Mar 5, 2026 — classified as 23 deaths, 99 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (34 reports).

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

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 27, 2023Class IIOpen, Classified

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

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

2. Dec 27, 2023Class IOpen, Classified

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

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

3. Jun 14, 2023Class IOpen, Classified

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

   Z-2111-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 185 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Malposition of Device

  A 37 YR-OLD FEMALE WITH HISTORY OF CARDIOMYOPATHY, BI-V ICD (BIVENTRICULAR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR), PRESENTED TO EMERGENCY DEPARTMENT IN CGS. CORONARY ANGIOGRAPHY PERFORMED REVEALING NORMAL CORONARIES. PATIENT CONTINUED TO DECOMPENSATE AND WAS PLACED ON V-A ECMO THE NIGHT BEFORE. IMPELLA 2.5 WAS PLACED ON (B)(6) 2021, VIA RIGHT FEMORAL ARTERY (RFA) FOR LEFT VENTRICLE UNLOADING. EXTRA-CORPOREAL FEM-FEM BYPASS PLACED DUE TO SMALL RFA AND DIMINISHED FLOW DOWN RIGHT LEG. ON (B)(6) 2021, PATIENT HAS PULMONARY EDEMA AND WAS SCHEDULED TO RECEIVE BRONC TREATMENT BY PULMONARY TEAM THAT SAME DAY. ON (B)(6) 2021, THERE WERE REPORTS OF HEMOLYSIS AS PLASMA FREE HB WAS UP FROM 30 TO 260 ON (B)(6): 315, (B)(6): 245. ADDITIONALLY, AN ARTICLE PUBLISHED IN 2025 RELATED TO THIS CASE INDICATED THAT ""THE 2.5 WAS REPOSITIONED DUE TO ARRHYTHMIA, AND WHEN THERE WAS HEMOLYSIS AND RENAL FAILURE, THE 2.5 WAS EXPLANTED AND REPLACED."" ON (B)(6) 2021, IMPELLA MIGRATED INTO LV (LEFT VENTRICLE) SHORTLY AFTER TRANSPORT TO (B)(6). DOCTOR PULLED IMPELLA BACK TO APPROPRIATE POSITION USING ECHO IMAGING.

  Patient problems: Arrhythmia; Hemolysis; Ischemia; Pulmonary Edema; Renal Failure

  MAUDE report 24524283 ↗
• DeathNov 27, 2024Positioning Failure; Positioning Failure

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, AFTER 30 MINUTES, THE PUMP MIGRATED OUT OF OPTIMAL POSITIONING WITHIN THE LEFT VENTRICLE. THE CLINICAL TEAM WAS UNABLE TO REPOSITION THE PUMP INTO THE LEFT VENTRICLE, AND AS A RESULT, THE DEVICE WAS EXPLANTED, AND A CP SUPPORT DEVICE WAS PLACED AND THE PATIENT EXPIRED SHORTLY THEREAFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797790 ↗
• DeathNov 27, 2024Restricted Flow rate; Restricted Flow rate

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING THE CORONARY INTERVENTION, THE RIGHT CORONARY ARTERY WAS DISSECTED FROM THE ORIGIN THE TO MID SECTION. IT WAS REPORTED THAT DURING SUPPORT, THE IMPELLA 2.5 WAS NOT PERFORMING OPTIMALLY WITH ONLY 0.5LPM FLOWS AND IRREGULAR WAVEFORMS WHILE THE PATIENT WAS RECEIVING CHEST COMPRESSIONS. IT WAS RECOMMENDED TO THE MEDICAL TEAM TO REPLACE THE PUMP WITH EITHER A NEW 2.5 IMPELLA OR TO ESCALATE TO AN IMPELLA CP. DUE TO THE PATIENT'S HEAVILY CALCIFIED FEMORAL AND ILIAC ARTERIES, THE PHYSICIAN OPTED TO REPLACE THE EXISTING 2.5 PUMP WITH A NEW 2.5 IMPELLA, WHICH IS FOR THIS REPORT. THIS SECOND IMPELLA 2.5 HAD OPTIMAL FLOWS FOR 10 MINUTES. THE PATIENT WAS REPORTEDLY COMPLETELY UNLOADING AND NON-PULSATILE AT 1.5 LPM AND BELOW, WHICH THE PHYSICIAN ATTRIBUTED TO RIGHT VENTRICLE HEART FAILURE. THE DECISION WAS MADE TO SEND THE PATIENT TO THE ICU AS THEY WERE HEMODYNAMICALLY STABLE AT THE TIME, HOWEVER DURING TRANSPORT THE PATIENT'S PRESSURES DROPPED AND NEVER RECOVERED. THE PATIENT EXPIRED WITHIN 15 MINUTES OF ARRIVING AT THE ICU.

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Low Blood Pressure/ Hypotension

  MAUDE report 20796312 ↗
• DeathNov 27, 2024Restricted Flow rate; Restricted Flow rate

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING THE CORONARY INTERVENTION, THE RIGHT CORONARY ARTERY WAS DISSECTED FROM THE ORIGIN THE TO MID SECTION. DURING SUPPORT, THE IMPELLA 2.5 WAS NOT PERFORMING OPTIMALLY WITH ONLY 0.5LPM FLOWS AND IRREGULAR WAVEFORMS WHILE THE PATIENT WAS RECEIVING CHEST COMPRESSIONS. IT WAS RECOMMENDED TO THE MEDICAL TEAM TO REPLACE THE PUMP WITH EITHER A NEW 2.5 IMPELLA OR TO ESCALATE TO AN IMPELLA CP. DUE TO THE PATIENT'S HEAVILY CALCIFIED FEMORAL AND ILIAC ARTERIES, THE PHYSICIAN OPTED TO REPLACE THE EXISTING 2.5 PUMP WITH A NEW 2.5 IMPELLA. THE SECOND IMPELLA 2.5 HAD OPTIMAL FLOWS FOR 10 MINUTES. THE PATIENT WAS REPORTEDLY COMPLETELY UNLOADING AND NON-PULSATILE AT 1.5 LPM AND BELOW, WHICH THE PHYSICIAN ATTRIBUTED TO RIGHT VENTRICLE HEART FAILURE. THE DECISION WAS MADE TO SEND THE PATIENT TO THE ICU AS THEY WERE HEMODYNAMICALLY STABLE AT THE TIME, HOWEVER DURING TRANSPORT THE PATIENT'S PRESSURES DROPPED AND NEVER RECOVERED. THE PATIENT EXPIRED WITHIN 15 MINUTES OF ARRIVING AT THE ICU.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20796121 ↗
• DeathNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN FDI 16. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20790505 ↗
• DeathNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED WHILE ON IMPELLA 2.5 SUPPORT, THE PATIENT EXPERIENCED SHORTNESS OF BREATH, TACHYCARDIA. AND A QUICK DROP OF BLOOD PRESSURE. THE PATIENT LOST PULSE, AND DESPITE ALL EFFORTS THE PATIENT CODED AND EXPIRED. THE RELATIONSHIP BETWEEN THE PATIENT'S OUTCOME AND THE IMPELLA IS UNKNOWN.

  Patient problems: Tachycardia

  MAUDE report 20790118 ↗
• DeathNov 26, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED THAT THE PATIENT WAS BEING PLACED ON IMPELLA 2.5 FOR HEMODYNAMIC SUPPORT. WHILE ON SUPPORT, IT WAS REPORTED THAT THE PEEL AWAY SHEATH WAS CRACKED AND PEELED. THE PATIENT THEN HAD LABS DRAWN AND THE LABS CAME BACK HEMOLYZED. AFTER 11 DAYS THE PATIENT AND FAMILY HAVE DECIDED ON NO ADDITIONAL TREATMENT. ADDITIONAL INFORMATION NOTED THE PATIENT WAS MADE A DO NOT RESUSCITATE, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THE RELATIONSHIP BETWEEN THE IMPELLA AND CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Hemolysis

  MAUDE report 20788331 ↗
• DeathNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, FLOWS DROPPED QUICKLY TO LESS THAN 0.5 L/MIN, CLOT SUSPECTED. THE PHYSICIAN ELECTED TO REMOVE THE PUMP, RUN IN BASIN OF STERILE SALINE, AND REINSERT. THE PUMP RESTARTED, AND THE FLOWS WERE APPROPRIATE FOR P LEVEL. PERFORATION REQUIRING COVERED STENT AND/OR BALLOON TAMPONADE. THE PATIENT EXPIRED. IT IS MORE LIKELY THAT THE OBTUSE MARGINAL 1 PERFORATION WAS THE CAUSE OF THE PATIENT'S DEATH. HOWEVER, THE IMMEDIATE LOW FLOW AT START OF SUPPORT THAT RESULTED IN EXPLANT AND RE-IMPLANT OF THE IMPELLA CATHETER CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR LEADING TO THE COMPLICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20784362 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INSERTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. AFTER REMOVAL, THE PERCLOSE FAILED, SO ANGIO SEAL WAS ATTEMPTED, UP AND OVER BALLOON TAMPONADE FOR HEMOSTASIS OF LYMPHOCYTE FUNCTION-ASSOCIATED ANTIGEN (LFA).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20782932 ↗
• MalfunctionNov 26, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE USER FACILITY REPORTED A PATIENT WITH CARDIOMYOPATHY WAS GOING TO BE ON AN IMPELLA 5.0 FOR MECHANICAL CIRCULATORY SUPPORT. DURING DELIVERY, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE PUMP ONCE COMING OUT OF THE SHEATH DUE TO PATIENT DISEASE (CALCIUM/STENOSIS). IT WAS NOTED THAT THE RED LUMEN WAS REPORTEDLY STICKING TO THE GUIDEWIRE AS IT WAS ADVANCING, AND THE RED LUMEN WAS CUT. AN ATTEMPT TO DELIVER THE IMPELLA 2.5 WAS MADE BUT IT WOULD NOT ADVANCE OUT OF THE SHEATH DUE TO CALCIFICATION AD STENOSIS OF THE VESSEL. THE PHYSICIAN DECIDED TO ABORT THE IMPLANT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780785 ↗
• MalfunctionNov 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED THAT DUE TO STENOSIS IN THE PATIENT'S VASCULATURE, THE IMPELLA PUMP WOULD NOT CROSS INTO THE AORTIC VALVE. IT IS UNKNOWN HOW THE COMPLICATION WAS MANAGED. IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780755 ↗
• MalfunctionNov 26, 2024Positioning Failure; Peeled/Delaminated; Positioning Failure; Peeled/Delaminated

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED JUST AFTER DELIVERING THE IMPELLA 2.5 INTO THE LEFT VENTRICLE, THE PUMP WAS FOUND TO HAVE SHIFTED BACK ACROSS THE VALVE. WHEN ATTEMPTS TO RE-CROSS THE VALVE FAILED, THE DEVICE WAS REMOVED FOR A COMPLETE REINSERTION ATTEMPT. HOWEVER, AFTER SUCCESSFULLY CROSSING THE VALVE A SECOND TIME, THE GUIDEWIRE WAS CAUGHT WITHIN THE PUMP AND THE PUMP WAS ONCE AGAIN REMOVED. ATTEMPTS TO SUBSEQUENTLY BACKLOAD THE PUMP OVER A THIRD WIRE RESULTED IN DAMAGE TO THE PEEL AWAY SHEATH AND THE DECISION WAS MADE TO USE A NEW PUMP. INSERTION WITH THE NEW PUMP WAS SUCCESSFUL WITHOUT FURTHER ISSUE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778694 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED AFTER THE SUCCESSFUL WEAN AND EXPLANT OF THE IMPELLA 2.5, A COVERED STENT WAS PLACED TO ACHIEVE HEMOSTASIS AT THE IMPELLA ACCESS SITE DUE TO DAMAGE CAUSED BY THE PERCLOSE DEVICE THAT WAS DEPLOYED AT THE START OF THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20772353 ↗
• DeathNov 25, 2024Restricted Flow rate; Restricted Flow rate

  THE COMPLAINANT REPORTED A PATIENT IN ST ELEVATION MYOCARDIAL INFARCTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED WHILE ON IMPELLA CP SUPPORT THAT THE PATIENT'S LABORATORY SAMPLES WERE HEMOLYZED. THE IMPELLA POSITION WAS VERIFIED HOWEVER THERE WAS NO INFORMATION PROVIDED ON IF HEMOLYSIS WAS RESOLVED OR ANY INTERVENTIONS PERFORMED. IT WAS ALSO NOTED THAT THE MEDICAL STAFF REQUESTED ABIOMED SUPPORT STAFF COME ONSITE. THEY STATED THAT THE PATIENT WAS DYING AND REQUIRED AN INCREASED HEMODYNAMIC SUPPORT. THE IMPELLA 2.5 WAS ALREADY OPERATING AT THE MAXIMUM FLOW LEVEL, AND ADVISED THE PATIENT WOULD NEED TO BE ESCALATED TO A LARGER PUMP. IT WAS NOTED THAT THE PATIENT LATER EXPIRED WHILE ON SUPPORT. THE RELATIONSHIP BETWEEN IMPELLA AND PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Hemolysis

  MAUDE report 20772145 ↗
• MalfunctionNov 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS BEING IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THE COMPLAINANT REPORTED THAT IMPELLA MET RESISTANCE IN THE STENOSED AREA OF THE ILIAC ARTERY. AFTER MULTIPLE ATTEMPTS TO PASS THE STENOSIS THE CASE WAS ABORTED AND THE 2.5 WAS EXPLANTED THROUGH THE PEEL AWAY SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749986 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INSERTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE PATIENT EXPERIENCED AN EPISODE OF VENTRICULAR TACHYCARDIA. THE PATIENT WAS CARDIOVERTED, AND THE RIGHT CORONARY ARTERY WAS STENTED TO MANAGE THE COMPLICATION. THE PATIENT NEEDED MORE HEMODYNAMIC SUPPORT, AND THE DECISION WAS MADE TO ESCALATE FROM AN IMPELLA 2.5 TO A IMPELLA CP.

  Patient problems: Tachycardia

  MAUDE report 20746516 ↗
• MalfunctionNov 21, 2024Increase in Pressure; Increase in Pressure

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE PURGE SYSTEM WAS BLOCKED, AND THE PURGE PRESSURE INCREASED, AND THE PURGE LINE WAS REMOVED AND THE PATIENT REMAINED ON SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746329 ↗
• InjuryNov 21, 2024Difficult to Remove; Difficult to Remove

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INSERTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, DURING IMPELLA CLOSURE, THE PERCLOSE FAILED. OOZING WAS OBSERVED AND A FEMSTOP WAS PLACED FOR THIRTY MINUTES TO MANAGE THE COMPLICATION. THE DEVICE WAS SUCCESSFULLY EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746275 ↗
• InjuryNov 21, 2024Difficult to Remove; Difficult to Remove

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INSERTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, DURING IMPELLA CLOSURE, THE PERCLOSE FAILED AND MANUAL PRESSURE WAS HELD FOR ONE HOUR TO MANAGE THE COMPLICATION. THE DEVICE WAS SUCCESSFULLY EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746172 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INSERTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE IMPELLA 2.5 WAS PROPERLY WEANED AND EXPLANTED, HOWEVER THE CLOSURE METHOD WAS SITE PRECLOSED WITH PROGLIDEX2 AND MANUAL PRESSURE HELD. POST ANGIOGRAM DONE FROM R RADIAL AND SLIGHT OOZING WAS NOTICED. THE PHYSICIAN DECIDED TO DO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH 7MMX40MM BALLOON, AND THE DEVICE WAS SUCCESSFULLY EXPLANTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20746068 ↗
• InjuryNov 21, 2024Difficult to Remove; Difficult to Remove

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INSERTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT AND DURING IMPELLA CLOSURE, ONE OF THE TWO PLACED PERCLOSE SUTURES BROKE. MANUAL PRESSURE WAS HELD TO ACHIEVE HEMOSTASIS AND THE DEVICE WAS SUCCESSFULLY EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746029 ↗
• DeathNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED THAT THE PATIENT WAS BEING PLACED ON IMPELLA 2.5 FOR HEMODYNAMIC SUPPORT. IT WAS REPORTED THAT THE PATIENT WAS HAVING LOTS OF BLEEDING AND RECEIVED BLOOD PRODUCTS, HEPARIN WAS DECREASED IN PURGE. IT WAS REPORTED THAT AFTER 223.28 HOURS OF SUPPORT THAT CARE WAS WITHDRAWN. THE PATIENT EXPIRED THEREAFTER WITH NO ALLEGATIONS MADE TOWARD THE IMPELLA AS THE CAUSE OF DEATH, HOWEVER THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20735471 ↗
• DeathNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS ON AN IMPELLA 2.5 FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT WAS BLEEDING AROUND THE FOLEY AND FROM THE MOUTH. PT OCCASIONALLY HAVE RUNS OF VT WITH COUGHING , DOCTOR REPOSITIONED. A GASTROINTESTINAL BLEED WAS ALSO IDENTIFIED. HEPARIN WAS DISCONTINUED. ADDITIONAL INFORMATION NOTED THE PATIENT WAS MADE A DO NOT RESUSCITATE, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Hemorrhage/Blood Loss/Bleeding; Tachycardia

  MAUDE report 20734185 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED AFTER THE IMPELLA 2.5 WAS SUCCESSFULLY WEANED AND EXPLANTED, THERE WAS DIFFICULTY TIGHTENING THE PERCLOSE DEVICE TO CLOSE THE IMPELLA ACCESS SITE. THE ACCESS SITE WAS OOZING AFTER PERCLOSE DEPLOYMENT, ASO ANGIOSEAL WAS ALSO DEPLOYED TO ACHIEVE HEMOSTASIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20730242 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA 2.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT DURING IMPELLA PLACEMENT, THE PATIENT EXPERIENCED EPISODES OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. IT WAS STATED THAT THE PATIENT WAS SHOCKED, AND RHYTHM WAS RESTORED. THE PATIENT REMAINED ON IMPELLA SUPPORT FOR THE INTERVENTION, AND WAS SUCCESSFULLY WEANED AND EXPLANTED.

  Patient problems: Arrhythmia; Tachycardia; Ventricular Fibrillation

  MAUDE report 20729217 ↗