Introducer Kit for Impella® 0052-3025 (UDI 00813502010664)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00813502010664), received between Nov 13, 2017 and Dec 31, 2019 — classified as 1 death, 22 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 FDA recall record name this device's identifier, 1 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-2678-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2019Break; Break

  IT WAS REPORTED A 14 FR X 23 CM THAT THE DILATOR TIP FRAYED (LOOKS TO BE SPLIT ON THE DISTAL TIP). THE ISSUE WAS IDENTIFIED DURING PROCEDURE, NOT INSERTED INTO THE BODY, NEVER ENTERED INTO THE VESSEL. PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DILATOR FROM A SHEATH KIT, NO PATIENT COMPLICATION OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9536406 ↗
• InjuryDec 10, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING HIGH RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) PROCEDURE IMPELLA WAS NOT ABLE TO ADVANCE BECAUSE KINKED PEEL AWAY SHEATH. KINK WAS VISUALIZED UNDER FLUOROSCOPY. PERCUTANEOUS AXILLARY TECHNIQUE USED FOR INSERTION AND NO ADDITIONAL DEVICE USED DURING PROCEDURE. PRODUCT ISSUE RESOLVED BY IMPLANTING ANOTHER IMPELLA FEMORALLY. THERE WAS NO PATIENT SIDE EFFECTS OR INTERVENTION REPORTED. THERE WAS 2 HOUR DELAY REPORTED IN SURGERY AS MD DECIDED TO TRY ANOTHER ACCESS SITE. PEEL AWAY SHEATH EXCHANGED BY 14FR COOK SHEATH BECAUSE PERCLOSE FAILED. USER HAD TO HOLD MANUAL PRESSURE WHICH DELAYED THE PROCEDURE. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. NO OTHER SERIOUS INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444607 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED INFORMATION, THE BLEEDING (OOZING) OCCURRED AROUND COMPETITOR'S SHEATH WHEN MICRO PUNCTURE TECHNIQUE WAS USED.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 9443664 ↗
• MalfunctionDec 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT WAS PRESENTED TO PHYSICIAN IN STABLE CONDITION FOR ELECTIVE PROCEDURE OF PRIMARY PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PPCI). THE PPCI PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION, THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. NEXT DAY DISCHARGE IS NORMAL, AS THE PATIENT WAS INPATIENT PRIOR TO THE PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, WHEN THE DILATOR WAS REMOVED FROM THE SHEATH, PRIOR TO PLACING THE IMPELLA THE PHYSICIAN EXPERIENCED OOZING WITH THE 13CM SHEATH AT THE VALVE. THE PROCEDURE WAS DELAYED FOR 5 MINUTES, THE ISSUE WAS RESOLVED BY SWAPPING OUT FOR ANOTHER 14F OSCOR SHEATH. MINIMAL BLOOD WAS LOST, NO BLOOD PRODUCT OR SURGICAL TECHNIQUE WAS REQUIRED TO CONTROL THE OOZING. REQUESTING ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437674 ↗
• InjuryNov 22, 2019Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  ADDITION INFORMATION RECEIVED THAT THE PATIENT HAD PVD (PERIPHERAL DISEASE) AND ALSO HAD AS (AORTIC STENOSIS. THE DELAY AND INABILITY TO PLACE THE PUMP WAS DUE TO THE HEART VALVE ALLOWING THE PUMP TO TRAVERSE IT. THIS IS NOT RELATED TO THE OSCOR SHEATH.

  Patient problems: Aortic Valve Stenosis; No Known Impact Or Consequence To Patient; Peripheral Vascular Disease

  MAUDE report 9364263 ↗
• MalfunctionNov 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS ADMITTED IN CARDIOGENIC SHOCK AND HAVING ACUTE MYOCARDIAL INFARCTION. DURING INSERTION AT FEMORAL ARTERY WHILE ADVANCING 0.035" WIRE THE SHEATH VALVE POPPED OUT. AS PER ADDITIONAL INFORMATION RECEIVED ON, OCTOBER 23,201 "THE VALVE POPPED OUT OF THE ORANGE RETAINING RING THAT HOLDS IT IN PLACE. THE ANGIOGRAPHIC PIGTAIL CATHETER THAT WAS BACKLOADED ON AN 0.035" GUIDE WIRE AND WAS BEING ADVANCED THROUGH THE OSCOR SHEATH VALVE. WHILE PUSHING IT THROUGH THE VALVE INTO THE BODY, THE VALVE POPPED OUT OF ITS POSITION IN THE SHEATH. WE HAD NO HEMOSTASIS WITH BACK BLEEDING FROM A STRAIGHT 14F CANNULA. THE VALVE FAILED COMPLETELY. IT WAS DETACHED FROM THE SHEATH AND UP ON THE PIGTAIL CATHETER AWAY FROM THE SHEATH ITSELF ABOUT 2-3CM. WE REMOVED THE PIGTAIL AND WIRE WITH THE VALVE STILL ON IT AND PLACED THE DILATOR IN THE SHEATH LUMEN TO CONTROL HEMOSTASIS. THE ORANGE RING WAS CRACKED BUT NOT AT THE NOTCH WHERE IT BREAKS WHEN WE PEEL AWAY. INSTEAD, THE ORANGE RETAINING RING FAILURE WAS OVER THE WHITE SHEATH WING ON THE SAME SIDE AS THE SIDE ARM. PATIENT LOSS 75C OF BLOOD, NO BLOOD PRODUCTS GIVEN. NO INTERVENTION REQUIRED. NO OTHER ADDITIONAL INFORMATION IS AVAIL

  Patient problems: Blood Loss

  MAUDE report 9355647 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PER ADDITIONAL INFORMATION, THERE WAS NO DAMAGE TO INTRODUCER REPORTED. THE INTERVENTIONAL CARDIOLOGIST DISCOVERED THE PERFORATION PRIOR TO INSERTING THE CP INTO THE 14 FR SHEATH. PATIENT WAS STABLE FROM THE PREVIOUS DAY, DUE TO THE URGENT NECESSITY OF TREATING THE PATIENT THE DECISION WAS MADE TO ATTEMPT THE PPCI AGAIN THE FOLLOWING DAY. INTRODUCER IS NOT AVAILABLE AS IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349071 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT ENDURED A RETROPERITONEAL BLEED CAUSED BY THE INTRODUCER. AS TREATMENT, HEPARIN WAS REDUCED AND THE BLEED WAS CONTAINED. AFTER BLEEDING WAS CONTAINED, HEPARIN WAS RESUMED. ON (B)(6) 2019, THE PATIENT EXHIBITED AN IRREGULAR HEART RHYTHM, CODED AND EXPIRED. IT WAS REPORTED THERE WAS NO ALLEGATION THAT THE OSCOR DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. HOWEVER IT WAS REPORTED THE OSCOR DEVICE WAS ALLEGED TO HAVE CAUSED THE BLEED, THE CUSTOMER REPORTED THE DEATH WAS NOT REPORTED AS RELATED TO THE BLEED. NO SPECIFIC PRODUCT PROBLEM WAS REPORTED. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Death

  MAUDE report 9335544 ↗
• MalfunctionNov 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT WAS PRESENTED TO PHYSICIAN IN CARDIOGENIC SHOCK. DURING INSERTION TO FEMORAL ARTERY 14FR OSCOR INTRODUCER HAD LEAK AT VALVE WHILE WIRE WAS INSIDE. SELDINGER TECHNIQUE WAS USE FOR INSERTION. PRODUCT WAS REPLACED WITH ANOTHER OSCOR 14FR. THERE WAS NO MEDICAL INTERVENTION OR ADDITIONAL SURGERY REQUIRED. PATIENT OUTCOME IS STABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304813 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS PRESENTED TO PHYSICIAN FOR EJECTION FRACTION OF 55% DROPPING TO 15%. DURING HIGH RISK PERCUTANEOUS CORONARY INTERVENTION, THE PHYSICIAN MADE THE DECISION TO LEAVE THE PEEL AWAY SHEATH IN THE PATIENT'S ANATOMY DURING SUPPORT WITH THE IMPELLA DEVICE. THIS WAS DONE TO PREVENT RISK OF LOSING PROPER POSITIONING OF THE IMPELLA. AS A RESULT, THE PATIENT'S LEG BECAME ISCHEMIC AND THE INTRODUCER WAS REMOVED. THERE WAS NO PARTICULAR MALFUNCTION REPORTED WITH THE DEVICE REPORTED, JUST THAT PATIENT ENDURED ISCHEMIA DUE TO INTRODUCER REMAINING IN ACCESS SITE DURING IMPELLA SUPPORT. TO RESOLVE ISCHEMIA, PHYSICIAN REMOVED THE INTRODUCER. INTRODUCER WAS REMOVED AND PUMP WAS ULTIMATELY REMOVED. NO NEW PUMP WAS INSERTED AND PATIENT CONTINUED SUPPORT VIA INOTROPIC MEDICATION. PATIENT OUTCOME IS STABLE. 1 DEVICE WAS PLANNED TO INTRODUCE ON THE INTRODUCER.

  Patient problems: Ischemia

  MAUDE report 8930300 ↗
• InjuryJul 12, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PATIENT AS PRESENTED TO PHYSICIAN WITH CHEST PAIN. PATIENT WENT INTO VENTRICULAR FIBRILLATION AND CRASHED ONTO ECMO. DURING ACUTE MYOCARDIAL INFARCTION / CARDIOGENIC SHOCK PROCEDURE PHYSICIAN WAS INSERTING THE INTRODUCER INTO THE PATIENT RIGHT FEMORAL ARTERY, WHILE INSERTING THE INTRODUCER THE PHYSICIAN EXPERIENCED "A LOT OF RESISTANCE. PEEL AWAY SHEATH REMOVED AND TAPERED SHEATH INSERTED INTO THE GROIN. EXCESSIVE BLEEDING FROM INSERTION SITE WAS IDENTIFIED. A HEMATOMA DEVELOPED AROUND THE INSERTION SITE. NO BLOOD PRODUCTS WERE REQUIRED. MANUAL PRESSURE AND SUTURES AT SITE WERE APPLIED. A NEW INTRODUCER WAS ULTIMATELY USED AND INSERTED WITHOUT ISSUE. IT'S UNKNOWN HOW MUCH BLOOD WAS LOST. PATIENT OUTCOME IS NO HARM.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 8786902 ↗
• InjuryJul 8, 2019Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  AS PER ADDITIONAL INFORMATION, GUIDEWIRE PASSED THROUGH DILATOR EASILY. RESISTANCE NOTICED INSIDE THE PATIENT ARTERY. PATIENT WAS RESCHEDULED FOR SURGERY AND PATIENT IS DOING FINE.

  Patient problems: Aortic Dissection

  MAUDE report 8768658 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, PATIENT WAS PRESENTED TO PHYSICIAN FOR CARDIAC ARREST WITH INTERMITTENT RETURN OF SPONTANEOUS CIRCULATION DURING EMS AND ER INTERVENTION. APPROXIMATELY 1 DAY AFTER, DURING ACUTE MYOCARDIAL INFARCTION / CARDIOGENIC SHOCK, IMPELLA IMPLANTED AND INTRODUCER PEELED AWAY. AS PER REPORTED EVENT, INTRODUCER WAS PEELED WHILE STILL IN PATIENT'S VESSEL, CAUSING THE BLEED. HEMOSTASIS WAS ACHIEVED AND PATIENT WAS IN STABLE CONDITION. 3 UNITS OF BLOOD PRODUCTS WERE GIVEN. PROCEDURE COMPLETED SUCCESSFULLY WITH IMPELLA CP DEVICE. NO NEW INTRODUCER WAS NEEDED. BLOOD PRODUCTS DELIVERED APPROXIMATELY 1 DAY AFTER INTRODUCER WAS REMOVED.

  Patient problems: Blood Loss; Hemostasis

  MAUDE report 8760516 ↗
• InjuryJun 26, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PATIENT WAS PRESENTED TO PHYSICIAN FOR TRIPLE VESSEL DISEASE. DURING HIGH RISK PERCUTANEOUS CORONARY INTERVENTION 25 CM FAILED TO INSERT AND 13CM SHEATH HAD DIFFICULTY IN INSERTING. 13CM INTRODUCER WAS PLACED WITH DIFFICULTY. WHEN EVENT OCCUR, USER WAS ATTEMPTING TO PASS PUMP THROUGH PATIENT ANATOMY WHEN HEAVILY CALCIFIED ARTERIES WERE FOUND. AFTER THAT FEMORAL ANGIOGRAM REVEALED PERFORATION. BECAUSE OF MULTIPLE INTRODUCER INSERTION ATTEMPTS VESSEL PERFORATION OCCURRED AND SURGICAL INTERVENTION REQUIRED TO REPAIR INJURY. THERE WERE NO SPECIFIC TECHNIQUE USED FOR INSERTION AND 1 DEVICE WAS PLANNED TO BE INTRODUCED IN THE DEVICE. DEVICE WAS USED IN TORTUOUS PATH. THE PROCEDURE WAS ABORTED, VASCULAR SURGERY WAS PERFORMED, AND PROCEDURE WAS SUCCESSFULLY COMPLETED THE FOLLOWING WEEK WITHOUT SUPPORT OF THE IMPELLA.

  Patient problems: Calcium Deposits/Calcification; Perforation

  MAUDE report 8734935 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT A (B)(6), WHITE, FEMALE WAS PRESENTED TO PHYSICIAN FOR CODING, DOING CPR (CARDIOPULMONARY RESUSCITATION). AFTER THE PCCS (PULMONARY CRITICAL CARE) PROCEDURE, WHILE THE PATIENT WAS IN ICU (INTENSIVE CARE UNIT) IT WAS NOTED THERE WAS BLEEDING AT INSERTION SITE; THE BLEEDING ISSUE HAS NOT BEEN IDENTIFIED. THESE MULTIPLE DEVICES WERE ALSO USED DURING THE PROCEDURE: INTRA-AORTIC BALLOON PUMP (IABP), IMPELLA AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). IT IS UNKNOWN HOW MUCH BLOOD THE PATIENT LOSS, HOWEVER THEY WERE GIVEN ONE (1) UNIT OF PACKED RED BLOOD CELLS (PRBC). THE PROCEDURE WAS COMPLETED WITH STANDARD PROTOCOL; DEVICE WAS REMOVED VIA VASCULAR SURGERY CUT DOWN AND THE EXPLANT WAS DUE TO HEART RECOVERY, NOT DEVICE FAILURE OR BLEEDING. IT WAS REPORTED THE PATIENT IS STILL ALIVE AND IN THE HOSPITAL. THE INTRODUCER WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.

  Patient problems: Blood Loss

  MAUDE report 8728737 ↗
• MalfunctionJun 12, 2019Break; Break

  IT WAS REPORTED THAT PATIENT WAS PRESENTED TO PHYSICIAN FOR CARDIOGENIC SHOCK POST OPEN HEART SURGERY. INTRA-AORTIC BALLOON PUMP USED PRIOR TO DECISION TO PLACE INTRODUCERS/IMPELLA PUMPS. WIRED ON 150CM 0.035 AMPLATZ WIRE USED FOR INSERTION. DURING ACCESS AT LEFT FEMORAL GUIDEWIRE KINKED. THERE WAS NO ISSUE WITH INTRODUCER THEREFORE, DECISION MADE TO ABORT USE OF THIS ACCESS SITE DUE TO DISSECTION ENDURED RELATING TO PREVIOUS IABP INSERTION. DURING ACCESS AT RIGHT FEMORAL PHYSICIAN FORGOTTEN THAT SHEATH HAS TWIST LOCK HUB, SO DURING PROCEDURE ONCE THE HUB BROKE, SHEATH REMOVED AND REPLACED. THERE WAS 10 MIN DELAY REPORTED AND MEDICAL INTERVENTION IS NOT RELATED TO SHEATH BUT RATHER UNDERLYING MEDICAL CONDITION OF PATIENT. PATIENT DID HAVE PROFOUND ANEMIA WITH CONCERN FOR RP BLEED, BUT IT WAS UNCONFIRMED. PATIENT DIED ON (B)(6) 2019 BECAUSE FAMILY WITHDREW CARE DUE TO FUTILITY. NO ADVERSE EVENT REPORTED NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8692828 ↗
• InjuryJun 4, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN INCIDENT OCCURRED DURING AN OUTPATIENT PROCEDURE IN THE CATH LAB, FOR HIGH RISK PCI (PERCUTANEOUS CORONARY INTERVENTION) ON (B)(6) 2019. PATIENT HAD SIGNIFICANT DISEASE IN HER ILIAC ARTERY AND DISTAL AORTA BUT THERE WAS NO PRIOR ANGIOGRAM THAT PRESENTED THIS BEFORE ATTEMPTING TO PLACE THE IMPELLA CP DEVICE ACROSS AORTIC VALVE. AS THE CP DEVICE WAS ADVANCED OVER THE .018 WIRE, IT MET RESISTANCE IN THE DISTAL AORTA. CP WAS REMOVED AND A PIGTAIL CATHETER WAS PLACED IN THE AORTA TO TAKE AN ANGIOGRAM. THAT REVEALED SIGNIFICANT DISEASE IN LEFT COMMON ILIAC, LEFT EXTERNAL ILIAC AND THAT THE OSCOR 14F X 13CM SHEATH WAS OCCLUDING FLOW TO THE LEFT DISTAL EXTREMITY. THE OCCLUSION LEAD TO LIMB ISCHEMIA AND THE NEED FOR A CUT DOWN IN THE OR WITH VASCULAR REPAIR AND PATCH. PATIENT'S PERIPHERAL ARTERIES ARE KNOWN TO BE CALCIFIED; OUTCOME OF PATIENT IS STABLE. DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED.

  Patient problems: Ischemia; No Consequences Or Impact To Patient

  MAUDE report 8667046 ↗
• InjuryApr 10, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN INCIDENT OCCURRED DURING A SURGICAL PROCEDURE FOR PLACEMENT OF AN IMPELLA ON (B)(6) 2019. AFTER THE PROCEDURE WAS OVER (AMIFOSTINE, CARDIOGENIC SHOCK IMPELLA INSERTION), WHILE THE PATIENT WAS IN ICU, THE PATIENT'S LEG WAS COLD AND THE PULSE WAS ABSENT. THE PATIENT WENT BACK TO THE CATH LAB FOR THE CONTRALATERAL BYPASS FOR LIMB ISCHEMIA. THE PATIENT WAS DRAPED IN STANDARD FASHION. THE OSCOR SHEATH 14F X 25CM WAS INSERTED INTO THE RIGHT FEMORAL ARTERY, THE IMPELLA WAS PLACED THROUGH THAT. OOZING OCCURRED AT THE INSERTION SITE, PREVENTING US FROM PEELING AWAY. CONTINUOUS OOZING AT THE SHEATH SITE RESULTED IN TRANSFUSION; TWO UNITS OF RED BLOOD CELLS WAS GIVEN AND AN ESTIMATED AMOUNT OF BLOOD LOSS 4 GRAMS OF HEMOGLOBIN. THE OSCOR SHEATH 14F X 25CM WAS OCCLUSIVE (NOT ALLOWING BLOOD FLOW TO PASS AND DOWN THE LEG). WE THEN PLACED A TERUMO RABBI SHEATH THAT IS 45CM LONG IN THE LEFT FEMORAL ARTERY, ADVANCED THE DISTAL TIP PAST THE OSCOR SHEATH AND DOWN THE RIGHT COMMON FEMORAL ARTERY TO PROVIDE DISTAL FLOW TO THE LOWER LEG. BLOOD LOSS WAS RESOLVED AFTER IMPELLA AND SHEATH WERE REMOVED, PERCLOSE DEPLOYED. LEFT FEMORAL ARTERY PROCEDURE TOOK APPROXIMATELY 1 HOUR. OUTCOM

  Patient problems: Blood Loss; Cardiogenic Shock; Ischemia

  MAUDE report 8499284 ↗
• InjuryApr 2, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PATIENT WAS ADMITTED PRE-OPERATIVE PLACEMENT OF THE IMPELLA PRIOR TO CORONARY ARTERY BYPASS GRAFTING SURGERY. INTRODUCER WAS USED FOR INSERTION AT THE RIGHT FEMORAL ARTERY FOR AN IMPELLA CP. THE PHYSICIAN HAD TO LEAVE 14FR OSCOR IN FOR 2 DAYS FROM 25TH FEBRUARY TO 27TH FEBRUARY, WITH EXTERNAL BYPASS PLACED TO REDUCE LIMB ISCHEMIA, ON 27TH FEBRUARY BLOOD LOSS WAS NOTICED AT THE INTRODUCER WHICH SATURATED THE GROIN SITE DRESSING. THE BLOOD LOSS WAS OCCURRING THROUGH THE VALVE OF THE INTRODUCER SHEATH. THE AMOUNT OF BLOOD LOSS IS UNKNOWN. THE PATIENT RECEIVED 1 UNIT OF BLOOD REPLACEMENT. BLEEDING REQUIRED INTRODUCER EXPLANT AND ADVANCEMENT OF THE IMPELLA REPOSITIONING SHEATH. DURING EXPLANT OF INTRODUCER VESSEL DAMAGE WAS OBSERVED, AS PER PHYSICIAN VESSEL DAMAGE IS RELATED TO PATIENT MOVEMENT. PATIENT WAS TAKEN TO HYBRID OR TO SURGICALLY REPAIR IMPELLA CP ACCESS SITE IN THE RIGHT LEG. RIGHT FEMORAL, AND RIGHT PROFUNDA SURGICAL PATCH AND RIGHT LOWER EXTREMITY THROMBOEMBOLECTOMY AND REMOVAL OF ATHEROSCLEROTIC PLAQUE WAS PERFORMED. PATIENT MAINTAINED HEMODYNAMIC STABILITY THROUGH THE SURGICAL PROCEDURE AND WAS TAKEN TO ICU. PROCEDURE COMPLETED WITH ANOTHER INTRODUCER

  Patient problems: Blood Loss; Ischemia

  MAUDE report 8475868 ↗
• MalfunctionMar 14, 2019Break; Break

  ON (B)(6) 2018, THE CUSTOMER WAS NOTIFIED THAT AN INCIDENT OCCURRED DURING A SURGICAL PROCEDURE FOR PLACEMENT OF AN IMPELLA CP. THIS (B)(6) MALE PATIENT WAS PRESENTED WITH FLU LIKE SYMPTOMS AND PROGRESSIVELY SUNK TO A FULL CARDIOMYOPATHY; DECISION WAS MADE TO PLACE IMPELLA CP. A 14FR X 25CM INTRODUCER SHEATH WAS PLACED BUT WHEN THE PHYSICIAN WAS TAKING OUT THE DILATOR, THE HEMOSTATIC VALVE AND ORANGE CAPS SPLIT AND POPPED OFF. THE MD IMMEDIATELY PUT DILATOR BACK IN AND SWAPPED OUT FOR THE SHORT OSCOR 14FR X 13CM INTRODUCER AND THE CASE PROCEEDED WITHOUT ISSUE. THE PATIENT WAS SUCCESSFULLY SUPPORTED. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE PHYSICIAN STATED THAT HE HAD UNSCREWED THE DILATOR FROM THE HUB PRIOR TO REMOVAL.

  Patient problems: Cardiomyopathy; No Known Impact Or Consequence To Patient

  MAUDE report 8420019 ↗
• InjuryMar 13, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING HIGH RISK PERCUTANEOUS CORONARY INSERTION, PHYSICIAN FAILURE TO ADVANCE PUMP DUE TO PATIENT TORTUOUS ANATOMY, THE PUMP BECAME STUCK IN THE INTRODUCER. WHEN REMOVING THE PUMP PHYSICIAN NOTICED KINK IN INTRODUCER AND DAMAGE TO DISTAL TIP. ADDITIONAL FORCE WAS USED TO REMOVE PUMP; HOWEVER, PUMP BEGAN TO SEPARATE. THEREFORE, INTRODUCER AND PUMP WERE REMOVED TOGETHER, RESULTING IN 300CC OF ESTIMATED BLOOD LOSS. AS TREATMENT, 1 UNIT OF BLOOD PRODUCTS WAS PROVIDED TO PATIENT. AS PER ADDITIONAL INFORMATION, WHEN PHYSICIAN PULLED THE SHEATH AND PUMP OUT AS UNIT, THE INLET WAS STUCK IN THE SHEATH AND THE CANNULA WAS TEARING APART. INITIALLY 13CM INTRODUCER WAS PLACED IN RIGHT AXILLARY ARTERY VIA CUT DOWN. CP WAS THEN INSERTED, BUT BECAME LODGED IN SHEATH; KINK WAS VISIBLE. TRYING TO PULL OUT CP, IT BEGAN TO PULL APART. WHILE TUGGING, EVERYTHING PULLED OUT OF ARTERY, BUT ENOUGH WIRE REMAINED TO KEEP ACCESS. THE SECOND INTRODUCER (25CM) WAS PLACED. IT KINKED AT SAME SPOT. HOWEVER, PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH SECOND INTRODUCER (25CM). NO ADDITIONAL INFORMATION IS AVAILABLE NO OTHER ADVERSE EVENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8416422 ↗
• InjuryMar 7, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PATIENT WAS PRESENTED TO THE PHYSICIAN IN CARDIOGENIC SHOCK STEMI. DURING THE PROCEDURE SHEATH PLACED TO LEFT FEMORAL ARTERY WITH MUCH DIFFICULTY AND THERE WAS NOTICEABLE KINK IN 14 FR 25CM LONG SHEATH. PHYSICIAN TRY TO ATTEMPT IMPELLA BUT UNABLE TO PASS, IMPELLA WAS REMOVED AND SHORT 14 FR 13CM SHEATH WAS EXCHANGED. THERE WAS NOTICEABLE BLEEDING AROUND SHEATH. TO CONTROL THE BLOOD LOSS 6 UNIT OF PRBC'S GIVEN. STAFF HELD MANUAL COMPRESSION OVER BLEEDING AREA, CONTRALATERAL BALLOON TAMPONADE WAS DONE TO CREATE HEMOSTASIS AFTER SHEATH WAS REMOVED. SURGICAL REPAIR OF THE ARTERY WAS PERFORM. THERE WAS 2 HOURS OF DELAY REPORTED. PROCEDURE COMPLETED WITHOUT IMPELLA SUPPORT. PATIENT OUTCOME IS STABLE AND NO OTHER ADVERSE EVENT REPORTED.

  Patient problems: Blood Loss; Hemostasis

  MAUDE report 8399278 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, AN (B)(6) MALE WAS HAVING A HIGH RISK PERCUTANEOUS CORONARY INSERTION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN USED A 14 FRENCH, 25 CM LENGTH OSCOR PEEL-AWAY INTRODUCER. THE PEEL-AWAY SHEATH WAS LEFT IN ACCESS SITE DURING THE PROCEDURE. AN ECHO REVEALED THE DEVICE'S POSITION WAS TOO SHALLOW, AND THEREFORE THE PEEL-AWAY WAS REMOVED BY THE PHYSICIAN TO HAVE BETTER STABILITY. SHORTLY AFTER REMOVAL, A SLIGHT OOZE DEVELOPED INTO A GROWING HEMATOMA. THEY PHYSICIAN SUSPECTED A TEAR IN THE PATIENT'S ARTERY WAS TO BLAME, CAUSED BY SHEATH REMOVAL. HOWEVER, IT SHOULD BE NOTED THAT THE ARTERIAL TEAR WAS ONLY SUSPECTED AND NEVER CONFIRMED. NO BLOOD PRODUCTS OR ADDITIONAL INTERVENTION WAS REQUIRED TO REMEDY THE BLEED, BESIDES EARLY REMOVAL OF THE IMPELLA CP PUMP AND SITE CLOSURE. PATIENT IS IN STABLE CONDITION AND DID NOT ENDURE ANY LASTING HARM. THE PEEL-AWAY SHEATH WAS DISCARDED.

  Patient problems: Hematoma

  MAUDE report 8366170 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, DURING A HRPCI PROCEDURE, THE DILATOR PERFORATED A L-ILIAC ARTERY. THE PHYSICIAN OBSERVED THE INCIDENT DURING THE ACTUAL PROCEDURE. AFTER THE PHYSICIAN HAD USED THE ABIOMED .018 WIRE AND THE BENSON WIRE, IT WAS NOTED THAT THE DILATOR PERFORATED L- ILIAC. A BALLOON USED TO CONTROL BLEEDING AND THE PERFORATION WAS REPAIRED. A 7F INTRODUCER WAS USED ABOVE PERFORATION TO DO INTERVENTION AND THE IMPELLA WAS PLACED WITHOUT ISSUE INSIDE R-ILIAC. THE PHYSICIAN USED BALLOON AND STENTS TO RCA AND KISSING BALLOONS AND STENTS TO LAD, LM AND CIRC. PRECLOSE X 2 WAS ALSO UTILIZED. PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 7902918 ↗
• MalfunctionSep 20, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING THE INSERTION OF THE IMPELLA PUMP THE 14F 13CM (SHORT SHEATH) HUB BROKE OPEN DURING DILATOR REMOVAL. THERE WAS A LARGE BLOOD RELEASE, AND THEY SCRAMBLED TO RE-WIRE AND REMOVE THE SHEATH. THE DEVICE WAS BEING USED FOR PRIMARY SUPPORT DURING REVASCULARIZATION. THE SECOND SHEATH (LONG SHEATH) WAS THEN PLACED OVER THE WIRE TO BE ABLE TO INSERT THE IMPELLA CP. PATIENT IS REPORTED TO BE STABLE. SEE MDR # 1035166-2018-00077 FOR 14F, 25CM SHEATH.

  Patient problems: Chest Pain; Ischemia; Myocardial Infarction

  MAUDE report 7893218 ↗

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-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-2680-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 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