Introducer Kit for Impella® 0052-3006 (UDI 00885672009755)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00885672009755), received between Mar 2, 2021 and Aug 7, 2026 — classified as 4 deaths, 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 reports).

2 FDA recall records name this device's identifier, 2 still open.

3 other recalls cover devices cleared under the same FDA submission (K122084); 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.

Recalls naming this device

1. Jun 10, 2026Class IOpen, Classified

   Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

   Z-2680-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Nov 7, 2023Class IIOpen, Classified

   Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

   Z-0646-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173572 ↗
• DeathJun 1, 2026Fluid/Blood Leak

  CLINICAL NARRATIVE AN IMPELLA 5.5 WAS INSERTED VIA THE RIGHT AXILLARY ARTERY VIA THE ABIOMED PROVIDED INTRODUCER KIT, TO SUPPORT THE 73 YEAR OLD MALE WITH ACUTE DECOMPENSATED CHRONIC CARDIOMYOPATHY, PRESENTING IN SCAI STAGE E SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE SURGEON PLACED THE PUMP AND FELT THAT THE GRAFT LOCK CLIPS WERE NOT TIGHT ENOUGH AND LESS TIGHT THAN USUAL, WHICH LEAD TO BLOOD LOSS/LEAKING AROUND THE SHEATH AND GRAFT. THE TEAM REPLACED THE SHEATH WITH A NEW SHEATH AND SUPPORT PROCEEDED. THERE WAS NO NOTED HARM FROM THE PRODUCT REPLACEMENT. THE TEAM DID NOTE THAT ALL BEST PRACTICES FOR ACCESS WERE FOLLOWED. THE SUPPORT WAS ONGOING FOR OVER 5 DAYS AND THEN THE TEAM MADE DECISION TO WITHDRAW CARE. WHILE ON THE SUPPORT THE 5.5 DEVICE FUNCTIONED AS INTENDED AT P-8 AT 4.7L/MIN WITH D5W SODIUM BICARBONATE IN THE PURGE SOLUTION. THERE WAS NO ALLEGATION THAT THE SHEATH LEAK CONTRIBUTED TO THE PATIENT OUTCOME. THE DEATH IS BEING CONSERVATIVELY REPORTED; HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE PATIENT¿S DEATH IS NOT ATTRIBUTED TO THE EVENT DESCRIBE AND IS MORE LIKELY ATTRIBUTABLE TO THE REPORTED CARDIOMYOPATHY, PRESENTING IN SCAI STAGE E.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25349032 ↗
• MalfunctionMay 28, 2026Crack; Fluid/Blood Leak; Patient Device Interaction Problem

  THE COMPLAINANT REPORTED THAT THE CARDIOVASCULAR SURGEON (CVS) PLACED 23F INTRODUCER (FROM AXILLARY KIT) INTO THE GRAFT AND PLACED 2 GRAFT LOCKS. CVS THEN CUT SOME OF THE GRAFT LENGTH AT THIS TIME. CVS THEN GAINED LV ACCESS AND EXCHANGED THE J-WIRE FOR THE 0.18 ABIOMED WIRE. CVS THEN PROCEEDED TO PLACE IMPELLA 5.5, BUT THE CVS DID NOT APPROVE THE LENGTH OF THE GRAFT. SOFT CLAMPS WERE PLACED OVER THE GRAFT AND THE CVS REMOVED THE PEEL AWAY SHEATH FROM THE GRAFT OVER THE 0.018 WIRE AND THEN CUT THE GRAFT DOWN TO HIS LIKING. THE CVS THEN ADVANCED THE PEEL AWAY SHEATH BACK INTO THE AXILLARY GRAFT. CVS THEN ADVANCED THE IMPELLA 5.5 TO THE HEMOSTATIC VALVE AND INITIALLY EXPERIENCED DIFFICULTY ADVANCING THROUGH THE HEMOSTATIC VALVE BUT DID ADVANCE THROUGH COMPLETELY. THE SOFT SOFT CLAMP WAS THEN REMOVED, AND BLEEDING WAS NOTED AT THE PEEL AWAY SHEATH / HEMOSTATIC VALVE AND APPEARS CRACKED. IT WAS ALSO NOTED THAT THE WIRE WAS SLIGHTLY ABOVE THE MIDDLE OF THE HEMOSTATIC VALVE. CVS THEN REMOVED THE IMPELLA 5.5 FROM THE GRAFT AND REAPPLIED THE SOFT CLAMPS. THE CVS THEN OPTED TO REMOVE THE 23 FRENCH PEEL AWAY SHEATH AND EXCHANGE IT FOR A NEW ONE. A NEW AXILLARY KIT WAS OPENED, AND NEW PEEL AWA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25323927 ↗
• InjuryMay 18, 2026Fluid/Blood Leak; Patient Device Interaction Problem

  CLINICAL NARRATIVE: AN IMPELLA 5.5 WAS INSERTED VIA THE DIRECT SURGICAL ACCESS AT THE AORTA FOR THE PATIENT ADMITTED IN WITH PLAN FOR A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY DUE TO MULTIVESSEL CORONARY ARTERY DISEASE. THE PATIENT PRESENTED AT SCAI STAGE E SHOCK AT THE ELECTIVE PUMP IMPLANT. THE OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE 5.5 WAS PLACED VIA THE 23FR SHEATH AND 10MM GELWEAVE GRAFT. THE INSTRUCTIONS FOR USE SPEAK TO A 10MM X20 HEMASHIELD PLATINUM GRAFT. AFTER THE GRAFT WAS ACCESSED WITH THE 23FR INTRODUCER THE TEAM APPLIED THE GRAFT LOCKS, HOWEVER THERE WAS PERSISTENT BLEEDING OUTSIDE THE DISTAL END OF THE GRAFT. TO REMEDY THE BLEED THEY HAD TO PLACE 3 HEAVY SILK TIES TO ACHIEVE HEMOSTASIS. THE TROUBLESHOOTING WAS NECESSARY DESPITE THE TEAM USING ALL BEST PRACTICES AT THE ACCESS. BLEEDING IN THIS CLINICAL CONTEXT IS A KNOWN AND EXPECTED RISK ASSOCIATED WITH IMPELLA 5.5 SUPPORT, PARTICULARLY IN THE SETTING OF MAJOR CARDIAC SURGERY AND DIRECT SURGICAL AORTIC ACCESS. THE PUMP REMAINED ON FOR SUPPORT TO DATE TILL WEAN AND EXPLANT. NO OTHER INTERVENTION, SUCH AS BLOOD PRODUCT DELIVERY, HAD BEEN DEEMED NECESSARY. THE PATIENT SURVIVES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25199812 ↗
• InjuryApr 29, 2026Patient Device Interaction Problem

  A 56-YEAR-OLD MALE UNDERWENT HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH IMPELLA CP SUPPORT FOR A PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D. THE IMPELLA CP WAS PERCUTANEOUSLY IMPLANTED VIA FEMORAL ARTERIAL ACCESS. DURING THE PROCEDURE, THE PATIENT WAS ON ANTICOAGULATION THERAPY WITH HEPARIN BOLUSES; DETAILS REGARDING ANTICOAGULATION MONITORING WERE UNKNOWN. WHILE THE INTRODUCER SHEATH REMAINED IN PLACE, ACCESS SITE BLEEDING MANIFESTED AS A HEMATOMA AT THE FEMORAL ARTERIOTOMY/VESSEL. DUE TO THE ACCESS SITE BLEEDING, THE IMPELLA DEVICE AND INTRODUCER WERE REMOVED, AND HEMOSTASIS WAS ACHIEVED FOLLOWING DEVICE REMOVAL. THE ESTIMATED BLOOD LOSS WAS UNKNOWN. THE PATIENT SURVIVED THE EVENT AND WAS STABLE AT EXPLANT. BLEEDING IS CONSISTENT WITH ACCESS SITE COMPLICATIONS AS A RESULT OF LARGE BORE FEMORAL PROCEDURES AND THE ANTICOAGULATION AND PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. IT IS UNKNOWN WHETHER RECOMMENDED BEST PRACTICES FOR ACCESS MANAGEMENT WERE FOLLOWED TO MITIGATE THE RISK OF BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25035623 ↗
• MalfunctionApr 21, 2026Contamination; Delivered as Unsterile Product

  IT WAS REPORTED THAT AN IMPELLA 5.5 SHEATH KIT WAS CONTAMINATED DURING THE PROCEDURE. ANOTHER KIT WAS USED TO SUCCESSFULLY SUPPORT THE PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938354 ↗
• MalfunctionApr 14, 2026Fluid/Blood Leak; Nonstandard Device; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Difficult or Delayed Separation

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT THERE WAS LEAKING OF BLOOD FROM THE PEEL AWAY SHEATH. THE SURGEON CLAIMS IT FEELS DIFFERENT. MORE STIFF THAN IN THE PAST AND THE VALVE WAS MORE DIFFICULT TO POP.

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

  MAUDE report 24872147 ↗
• DeathApr 13, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 72-YEAR-OLD MALE PATIENT PRESENTING WITH CARDIOMYOPATHY, WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE AND DIABETES MELLITUS. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. THE PATIENT WAS PREVIOUSLY IN THE CATH LAB AND RECEIVED ANTI-PLATELET AND BLOOD THINNERS FOR PCI. THREE HOURS AFTER RECEIVING ANTICOAGULATION, THE PATIENT WAS TAKEN TO THE OR FOR IMPELLA 5.5 PLACEMENT. THE PATIENT WAS NOTED TO BE VERY OOZY, REQUIRING A BLOOD TRANSFUSION AND DDAVP. SURGICAL SITE BLEEDING OCCURRED AT THE AXILLARY SITE, AS WELL AS BLEEDING FROM THE URINARY CATHETER AND ALL ACCESS SITES (IV, ARTERIAL LINE, ENDOTRACHEAL TUBE). A DRAIN WAS PLACED PER HOSPITAL PROTOCOL AND COLLECTED 200 CC OF BLOOD IN ABOUT 30 MINUTES. THE SURGICAL TEAM ATTRIBUTED ALL BLEEDING TO THE ANTI-PLATELET LOAD AND ANTICOAGULATION MEDICATIONS GIVEN IN THE CATH LAB. ONE UNIT OF PACKED RED BLOOD CELLS WAS ADMINISTERED. OTHER CONTRIBUTING FACTORS INCLUDED CATH LAB PCI WITH ANTI-PLATELET MEDICATIONS AND BLOOD THINNERS. THE PATIENT EXPIRED ON SUPPORT. THE MAJOR BLEED IS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24863319 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN INTRODUCER (MATERIAL # 0052-3006, LOT # S9649272). A U.S. COMPLAINANT REPORTED THAT DURING AN IMPELLA 5.5 WITH SMARTASSIST IMPLANTATION PROCEDURE ON (B)(6) 2026, THE 23FR PEEL-AWAY INTRODUCER WAS OBSERVED TO BE LEAKING FROM THE SIDEARM AT THE CONNECTION POINT BETWEEN THE SIDEARM AND THE INTRODUCER. THE COMPLAINANT DESCRIBED A STEADY STREAM OF BLOOD FROM THE GRAFT. NO CRACKS OR VISIBLE DAMAGE WERE NOTED ON THE INTRODUCER. DESPITE THE LEAK, THE INTRODUCER REMAINED USABLE AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT PRESENTED TO THE PHYSICIAN WITH AMI/CGS AND REMAINED ALIVE FOLLOWING THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM AND NO MEDICAL INTERVENTION REQUIRED RELATED TO THE LEAK. ADDITIONAL DEVICES USED INCLUDED AN IMPELLA 5.5 WITH SMARTASSIST S2 SET, US (1000100), LOT #2026741033, SERIAL # (B)(6). NO DAMAGE WAS NOTED TO THE IMPELLA PRODUCT. THE INTRODUCER WAS DISCARDED AFTER THE PROCEDURE AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729839 ↗
• DeathMar 26, 2026Break; Difficult to Flush

  AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 67-YEAR-OLD MALE PATIENT PRESENTING WITH CARDIOMYOPATHY, SCAI SHOCK STAGE E. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE AXILLARY SHEATH STOP-COCK DID NOT FUNCTION APPROPRIATELY AND DID NOT FLUSH CORRECTLY. THE PATIENT SUBSEQUENTLY EXPIRED ON SUPPORT. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTABLE TO THE SEVERITY OF THE UNDERLYING CARDIOMYOPATHY AND CARDIOGENIC SHOCK ASSOCIATED WITH SCAI SHOCK STAGE E.

  Patient problems: Hemodynamic instability

  MAUDE report 24697831 ↗
• InjuryMar 22, 2026Fluid/Blood Leak

  AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 58-YEAR-OLD FEMALE PATIENT PRESENTING IN HEART FAILURE/CARDIOGENIC SHOCK, CARDIOMYOPATHY, IN SCAI STAGE C SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. DURING THE PROCEDURE, THERE WAS BLOOD LEAKING AROUND THE GRAFT LOCKS. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT HAD RENAL FAILURE REQUIRING DIALYSIS. TWO MONTHS AFTER IMPELLA INSERTION, THE DEVICE WAS REMOVED WITH A BRIDGE TO A HEART TRANSPLANT. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-6 AT 3.3L/MIN AS INTENDED. RENAL FAILURE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH IMPELLA'S MECHANICAL SUPPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24658301 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  CLINICAL ASSESSMENT: 63 YEAR OLD MALE PATIENT TREATED WITH IMPELLA 5.5 DUE TO ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. PATIENT WAS ADMITTED TO HOSPITAL FOR HEART FAILURE. PATIENT ACUTELY IN CARDIOGENIC SHOCK AND HAD CARDIAC ARREST IN CATHETER LABORATORY. PLACED ON EXTRACORPOREAL LIFE SUPPORT AND WHEN PATIENT LOST CONTRACTILITY AND EJECTION FRACTION WAS DEEMED 5 % EMERGENT IMPELLA 5.5 INSERTION DECISION WAS TAKEN. DURING INSERTION SHEATH PLACED AND HCP WAS UNABLE TO GET HEMOSTASIS. SHEATH APPEARS TO BE LEAKING AND DECISION WAS TAKEN TO REPLACE SHEATH WITH A NEW ONE. FIRST DAY OF SUPPORT PUMP EXPERIENCED DROP IN PURGE FLOWS WITHOUT SPIKES IN MOTOR CURRENT. NO FURTHER CHANGES IN OTHER PUMP METRICS AND NO PURGE PRESSURE ALARMS AS WELL AS NO LEAKS IN THE SYSTEM. DECISION WAS TAKEN FOLLOWING MD CONSULTATION TO EXCHANGE PURGE FOR TISSUE PLASMINOGEN ACTIVATOR. DAY SIX OF SUPPORT PATIENT DECANNULATED FROM EXTRACORPOREAL LIFE SUPPORT AND EXPERIENCED NEUROLOGICAL DELAYS AND POSSIBLE STROKE SYMPTOMS; THIS IS CONSERVATIVELY CODED FOR STROKE IN THIS CASE TO THE IMPELLA 5.5, BUT DUE TO MULTIPLE MECHANICAL CIRCULATORY SUPPORT SYSTEMS CANNOT SOLELY BE ATTRIBUTED TO THE IMPELLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526819 ↗
• DeathFeb 26, 2026Difficult to Open or Close

  THE COMPLAINANT REPORTED AN ISSUE INVOLVING AN IMPELLA SHEATH AND INSERTION KIT DURING A CLINICAL PROCEDURE. SPECIFICALLY, DIFFICULTIES WERE REPORTED WITH THE GRAFT LOCK AND THE PEEL-AWAY SHEATH DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT EXPERIENCED NO HARM.

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

  MAUDE report 24457556 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL REVIEW/RATIONALE: AN IMPELLA 5.5 WAS INSERTED VIA RIGHT AXILLARY ARTERY IN A 47 YEAR OLD MALE FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. DURING ARTERIOTOMY ACCESS, BLEEDING WAS NOTED AND THE PATIENT RECEIVED 2 UNITS OF BLOOD. IT IS REPORTED THAT HEMOSTASIS WAS REPORTED WITH SURGERY. THE REPORTED BLEEDING MAY OCCUR IN THE SETTING OF VASCULAR ACCESS AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS THE UNDERLYING CARDIOGENIC SHOCK PHYSIOLOGY, HEMODYNAMIC INSTABILITY, AND DEVICE POSITION. ON DAY 2 OF SUPPORT, THE PATIENT'S URINE OUTPUT WAS GREATER THAN 30 CC/HR AND CONCENTRATED, AMBER IN COLOR. ON DAY 3 OF SUPPORT, THE FAMILY DECIDED TO WITHDRAW CARE AND THE PATIENT EXPIRED. THE REPORTED HEMATURIA MAY OCCUR IN THE SETTING OF PURGE-RELATED ANTICOAGULATION REQUIREMENTS AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS THE UNDERLYING CARDIOGENIC SHOCK PHYSIOLOGY, HEMODYNAMIC INSTABILITY, AND DEVICE POSITION. THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT¿S DEATH, WHICH WAS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING C

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23999867 ↗
• MalfunctionJul 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN INTRODUCER (MATERIAL#: 0052-3006, LOT#: DP-21849). IT WAS REPORTED THAT THE AXILLARY SHEATH FOR 5.5 WAS DAMAGED OUT OF THE PACKAGE, FOUND DURING THE PROCEDURE. ONCE PLACED INTO THE 10MM PLATINUM GRAFT AND TWO GRAFT LOCKS PLACED THERE WAS SIGNIFICANT BLEEDING FROM PERFORATION POINTS DOWN THE SIDES OF THE HUB. NEW AXILLARY SHEATH PLACED; ISSUE RESOLVED. THE PATIENT RECEIVED 3 UNITS OF PRBC (PACKED RED BLOOD CELLS). ADDITIONALLY, THE PATIENTS' OUTPUTS DROPPED OVERNIGHT, AND SUCTION ALARM OCCURRED ON P8. LV (LEFT VENTRICLE) SEEMED TO BE SUCKED DOWN. DOWN TO P7 AND FLOLAN STARTED TO HELP RIGHT TO LEFT FLOW. (FLOLAN IS A BRAND NAME FOR EPOPROSTENOL, TO TREAT PULMONARY HYPERTENSION, ACTS AS VASODILATOR). PATIENT RECOVERED AND WAS EVENTUALLY WEANED OFF LEVO (LEVOPHED/NOREPINEPHRINE, VASOCONSTRICTOR). THE PATIENT HAD A RIGHT MCA (MIDDLE CEREBRAL ARTERY) STROKE. CARE WAS ULTIMATELY WITHDRAWN, AND THE PATIENT EXPIRED. NO MEDICAL INTERVENTION OR ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. THERE WAS NO PROCEDURE DELAY, THE DEVICE WAS NOT USED IN A TORTUOUS PATH WHEN THE EVENT OCCURRED. NO SPECIFIC TECHNIQUE WAS USED FOR INSERTION; ALL BEST PRACT

  Patient problems: Cardiogenic Shock; Ischemia Stroke

  MAUDE report 22507904 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE START OF THE IMPELLA 5.5 IMPLANT, OOZING FROM AXILLARY KIT SHEATH WITHOUT IMPELLA YET IN PLACE OCCURRED. THE OOZING WAS LOCATED AT THE BLUE RING AT PRE PERFORATED AREA. THE SHEATH WAS SPLIT. THE SHEATH WAS EXCHANGED, AND IMPELLA WAS INSERTED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913058 ↗
• MalfunctionOct 29, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  PATIENT'S CONDITION WHEN PRESENTED TO THE PHYSICIAN WAS CARDIOMYOPATHY; PATIENT IS A 74-YEAR-OLD, WHITE FEMALE. DURING THE PROCEDURE WHEN THE PHYSICIAN WAS INSERTING THE INTRODUCER INTO THE 8MM GRAFT; THE SHEATH STARTED LEAKING, AND IT WAS FOUND THAT THE TIP WAS SPLIT. THE DEVICE WAS NOT USED IN A TORTUOUS PATH WHEN EVENT OCCURRED. THE CLINICAL REPRESENTATIVE DOES NOT KNOW THE BRAND NAME, MODEL OR LOT NUMBER OF THE SECOND INTRODUCER THAT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION, NO ADDITIONAL SURGERY, AND NO PROCEDURE DELAY. ADDITIONAL DEVICES USED DURING THE PROCEDURE ARE AN IMPELLA 5.5 WITH SMARTASSIST S2 SET, US (1000100) LOT NUMBER 2025547602, SERIAL NUMBER (B)(6). NO PATIENT INJURY REPORTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556574 ↗
• MalfunctionOct 14, 2023Break; Break

  WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER (MATERIAL #0052-3006, LOT # DP-17198). PATIENT WAS SUFFERING FROM CARDIOMYOPATHY AND DURING IMPLANT OF AN IMPELLA 5.5 PUMP, BLOOD WAS SEEN AT THE SIDE OF THE HEMOSTATIC VALVE. UPON REMOVAL OF THE INTRODUCER, IT WAS NOTED THAT THE COMPONENT WAS CRACKED. NO BLOOD PRODUCTS WERE REQUIRED, AND A SECOND AXILLARY KIT WAS AVAILABLE FOR USE AS NEEDED. NO MEDICAL INTERVENTION WAS REQUIRED AND THERE WAS NO DELAY IN THE PROCEDURE. PATIENT IS A 48-YEAR-OLD, MALE AND IS IN STABLE CONDITION. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936782 ↗
• MalfunctionOct 4, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER (MATERIAL #0052-3006, LOT # C1-19947). DURING IMPELLA 5.5 IMPLANT, THE INTRODUCER CRACKED AND BEGAN LEAKING. THE INTRODUCER WAS REPLACED AND THE SUBSEQUENT IMPELLA 5.5 IMPLANT WAS SUCCESSFUL. THERE WAS NO PATIENT HARM AND NO INTERVENTION. ADDITIONAL DEVICES USED DURING THE PROCEDURE INCLUDE IMPELLA 5.5 PUMP, (B)(6), LOT # 2022043492, PRODUCT NUMBER 0550-0008. THERE WAS MINIMAL DELAY. SWAPPED INTRODUCER AND IMPLANT WAS SUBSEQUENTLY SUCCESSFUL. STANDARD TECHNIQUE USED FOR INSERTION. ADDITIONAL INFORMATION RECEIVED 09/14/2023. THE IMPELLA 5.5 PUMP WAS THE ONLY DEVICE INSERTED THROUGH THE SHEATH AT THE TIME OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH MODEL NUMBER AND LOT NUMBER 0052-3006, C1-19943. NO ISSUE REPORTED REGARDING PATIENTS' ANATOMY. PRODUCT WAS DISCARDED; THEREFORE, WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868244 ↗
• MalfunctionSep 12, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A 73 YEAR OLD MALE WAS PRESENTED TO THE PHYSICIAN WITH SHORTNESS OF BREATH AND UNDERWENT AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK PROCEDURE ON (B)(6) 2022 INVOLVING AN OSCOR 23 FR INTRODUCER. AFTER INSERTING THE INTRODUCER THROUGH THE SURGICAL GRAFT, BLOOD WAS NOTED LEAKING AROUND THE SHEATH, DESPITE TIGHTENING THE GRAFTS LOCKS. THE BLEED RESOLVED AFTER THE INTRODUCER WAS REMOVED AND A NEW 23 FR OSCOR INTRODUCER WAS INSERTED. A SPLIT WAS NOTED; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. A ADDITIONAL DEVICE, VASCUTEK GELWEAVE GRAFT WAS USED DURING THE PROCEDURE. THERE WAS A DELAY IN INSERTING THE IMPELLA DUE TO BLEEDING. NO INTERVENTION REPORTED, BEYOND CHANGING OUT THE INTRODUCER. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15404092 ↗
• MalfunctionJun 3, 2022Break; Break

  ON (B)(6) 2022 A (B)(6) MALE ADMITTED SUFFERING FROM CARDIOMYOPATHY UNDERWENT A PROCEDURE FOR ACCESS AT AXILLARY GRAFT FOR PLACEMENT OF THE IMPELLA 5.5. TODAY A COMPLAINT WAS FILED INCLUSIVE OF YOUR INTRODUCER PACKAGED WITHIN OUR AXILLARY SET. THE FIELD REP NOTED THE SHEATH CRACKED DURING PLACEMENT INTO THE GRAFT AND PLACING GRAFT LOCKS. PATIENT REPORTED AS STABLE. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. NO MEDICAL INTERVENTION WAS GIVEN. PATIENT IS STILL ON IMPELLA SUPPORT. THE PROCEDURE WAS COMPLETED WITH A NEW SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14592051 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DELIVER THE IMPELLA 5.5 DEVICE THROUGH THE INTRODUCER, AT WHICH POINT, THE GUIDE WIRE CAME OUT OF POSITION. THE DECISION WAS MADE TO REMOVE THE PUMP AND START OVER. DURING 2ND ATTEMPT TO DELIVER THE DEVICE, THE PUMP ENDURED RESISTANCE WHEN PASSING THE DISTAL TIP OF THE INTRODUCER. THE PUMP AND INTRODUCER WERE REMOVED TO FIND A SMALL TEAR AT THE END OF THE INTRODUCER. A NEW INTRODUCER WAS USED WITHOUT FURTHER ISSUE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13290470 ↗
• MalfunctionOct 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021 A (B)(6) FEMALE PATIENT UNDERWENT A PROCEDURE FOR AXILLARY ARTERY INSERTION OF THE IMPELLA 5.5. THE AXILLARY INSERTION SHEATH WAS BLEEDING AFTER INSERTION INTO THE GRAFT DESPITE GRAFT LOCKS IN PLACE. SHEATH REMOVED AND REPLACED WITH ANOTHER WITHOUT ANY ISSUE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674623 ↗
• MalfunctionSep 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT WAS PRESENTED TO THE PHYSICIAN WITH THE CONDITION OF DEPRESSED LEFT VENTRICLE FUNCTION AND MODERATE AORTIC INSUFFICIENCY (AI). THE 23F INTRODUCER WAS USED FOR A CARDIOMYOPTHY PROCEDURE, FOR A BRIDGE TO TRANSPLANT. A BLEED OCCURRED BETWEEN THE 23FR INTRODUCER AND GRAFT ONCE THE GRAFT LOCKS WERE DEPLOYED, NOT A FULL HEMOSTASIS. IT IS NOT KNOWN HOW MUCH BLOOD WAS LOST, HOWEVER, NO BLOOD PRODUCTS WERE REQUIRED AND THE PATIENT WAS NOT HARMED AS A RESULT OF THE BLEED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12466746 ↗
• MalfunctionJul 28, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED TO THE PHYSICIAN POST-ARREST WHILE UNDERGOING CPR. DURING PROCEDURE, 23FR INTRODUCER LEAKED AFTER PLACEMENT. AFTER ATTACHING TO GRAFT, PHYSICIAN NOTED THAT THE INTRODUCER WAS CRACKED OUT OF THE PACKAGE. A SECOND 23 FR AXILLARY INTRODUCER WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO HARM TO PATIENT REPORTED. NO ADVERSE EVENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242380 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122084. One submission often covers many models, so check the product and lot details in each record.

• Z-2678-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
• Z-2679-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
• Z-1467-2021 · Feb 22, 2021 · Terminated
  AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheter