Introducer Kit for Impella® 0052-3021 (UDI 00885672009786)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885672009786), received between Jul 26, 2021 and May 21, 2024 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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-2679-2026 · 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-0649-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT HAD CARDIAC ARREST AT HOME AND BROUGHT TO THE HOSP. PATIENT HAD RETURN OF SPONTANEOUS CIRCULATION(ROSC). ECHO SHOWED EJECTION FRACTION OF 10%.IMPELLA RP WAS PLACED IN THE LEFT FEMORAL AND NOTABLE KINK WAS SEEN IN THE SHEATH IN THE FEMORAL-ILIAC ANATOMICAL REGION. 027 IMPELLA GUIDEWIRE WAS ADVANCED THROUGH DUAL LUMEN PULMONARY ARTERY (PA) CATHETER TO HOLD POSITION, THEN PA CATHETER ADVANCED SUCCESSFULLY THROUGH THIS KINK IN SHEATH. PA CATHETER TO LEFT PA AND 027 WIRE WAS BURIED VERY DEEP IN LEFT PA. RP WAS ADVANCED OVER WIRE AND TO LEFT PA. THE IMPELLA WIRE WAS REMOVED AND RP STARTED AT P2. IMPELLA STOPPED ALARM OCCURRED AND MOTOR CURRENT HIGH ON AIC. THE IMPELLA WAS RESTARTED AT P2 SUCCESSFULLY. THEN SLOW GRADUAL INCREASE IN P LEVEL UNTIL REACHING P9 WITH FLOWS OF 4-4.1 LPM. THE CASE CONTINUED WITH NO FURTHER SIMILAR ALARMS, ONLY SUCTION ALARMS. THE CASE WAS COMPLETED. THE PATIENT WAS VERY SICK AND WAS BEING CODED DURING OUR PROCEDURE. CAUSE OF DEATH WOULD BE CARDIAC ARREST AND PHYSICIAN DID NOT SAY ITS RELATED TO DEVICE.

  Patient problems: Cardiac Arrest

  MAUDE report 19367148 ↗
• InjuryNov 30, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER (MATERIAL # 0052-3021, LOT # DP17331). ON (B)(6) 2023, A 64-YEAR-OLD FEMALE PATIENT WAS PRESENTED TO PHYSICIAN WITH RIGHT HEART FAILURE. IT WAS REPORTED AN IMPELLA RP DEVICE WAS PLACED VIA RIGHT FEMORAL VEIN. TECHNIQUE USED FOR INSERTION WAS FOLLOWED ACCORDING TO IMPELLA RP INSTRUCTIONS FOR USE (IFU). WHEN REMOVING THE INTRODUCER, THE INTRODUCER SHEATH CRACKED, RESULTING IN OOZING FROM SHEATH DURING PROCEDURE. BEFORE LEAVING CATH LAB, THE PATIENT REQUIRED A BLOOD TRANSFUSION, (B)(4) UNIT OF PACKED RED BLOOD CELL (PRBC). THE PATIENT WAS BROUGHT TO SURGICAL INTENSIVE CARE UNIT (SICU). CARE WAS WITHDRAWN THE NEXT DAY (B)(6) 2023, AND PATIENT EXPIRED. PER END USER, CAUSE OF DEATH, CARE WAS NOTED TO BE WITHDRAWN FROM PATIENT. THE DEVICE WAS DISCARDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18237297 ↗
• MalfunctionMay 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PLACEMENT OF IMPELLA RP SHEATH PEELED AWAY AND THERE WAS LEAKING. PATIENT OUTCOME IS STABLE AND NO HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031736 ↗
• InjuryNov 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER WAS NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER ON 10/01/2022 DURING A POST-OP CARDIOTHORACIC SURGERY. THERE WAS A REPORT OF A CRACKED SHEATH IN THE RIGHT FEMORAL VEIN UPON INSERTION ON BEHALF OF ST. VINCENT HEALTHCARE - BILLINGS. A SECOND PEEL-AWAY SHEATH WAS INSERTED TO REPLACE THE DAMAGED COMPONENT. THE EVENT WAS REPORTED UNDER (B)(4) AND SALESFORCE CASE #(B)(4). PATIENT PRESENTED WITH RV FAILURE OVERNIGHT/THROUGH THE DAY. PUMP INSERTION FOR PATIENT SUPPORT WAS SUCCESSFUL FOLLOWING THE PEEL-AWAY SHEATH REPLACEMENT. REPORT OF ACCESS SITE BLEED, SKIN SUTURES AND TWO UNITS OF PACKED RED BLOOD CELLS WERE TRANSFUSED. IMPELLA SUPPORT CONTINUED THROUGHOUT THE EVENT. THE CUSTOMER DISCARDED THE PRODUCT. REFERENCE REPORT # 1035166-2022-00111.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15715357 ↗
• InjuryNov 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER WAS NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER ON (B)(6) 2022 DURING A POST-OP CARDIOTHORACIC SURGERY. THERE WAS A REPORT OF A CRACKED SHEATH IN THE RIGHT FEMORAL VEIN UPON INSERTION ON BEHALF OF (B)(6) HEALTHCARE - BILLINGS. A SECOND PEEL-AWAY SHEATH WAS INSERTED TO REPLACE THE DAMAGED COMPONENT. THE EVENT WAS REPORTED UNDER (B)(4) AND SALESFORCE CASE # (B)(4). PATIENT PRESENTED WITH RV FAILURE OVERNIGHT/THROUGH THE DAY. PUMP INSERTION FOR PATIENT SUPPORT WAS SUCCESSFUL FOLLOWING THE PEEL-AWAY SHEATH REPLACEMENT. REPORT OF ACCESS SITE BLEED, SKIN SUTURES AND TWO UNITS OF PACKED RED BLOOD CELLS WERE TRANSFUSED. IMPELLA SUPPORT CONTINUED THROUGHOUT THE EVENT. THE CUSTOMER DISCARDED THE PRODUCT. REFERENCE REPORT # 1035166-2022-00116.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15715090 ↗
• MalfunctionAug 10, 2022Break; Break

  IT WAS REPORTED THAT A 85 YEAR OLD FEMALE UNDERWENT A PROCEDURE FOR PLACEMENT OF THE IMPELLA RP. A COMPLAINT WAS ENTERED INCLUSIVE OF YOUR 23FR SHEATH. WE EXPECT THE PRODUCT TO BE RETURNED, BUT TO DATE NOTHING HAS BEEN RETURNED. THE FIELD REP NOTED THE FOLLOWING: THE ABIOMED 23FX30CM SHEATH WAS THEN INSERTED WITHOUT ISSUE. HEPARIN WAS NOT GIVEN PER THE REQUEST OF THE DR., THE DILATOR WAS THEN REMOVED. UPON REMOVAL OF THE DILATOR, A CRACK IN THE 23F ABIOMED SHEATH BECAME EVIDENT, AND BLEEDING WAS PRESENT. A REPLACEMENT 23FX30CM SHEATH WAS QUICKLY LOCATED AND THE BROKEN SHEATH WAS REPLACED WITHOUT ISSUE. THE PATIENT EXPIRED WHEN FAMILY CHOSE TO WITHDRAW CARE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15198412 ↗
• MalfunctionJul 21, 2022Break; Break

  ON (B)(6)2022, THE PATIENT A 65 YEAR OLD, MALE WAS PRESENTED TO THE PHYSICIAN WITH DETERIORATED HEMODYNAMICS. THE PHYSICIAN REPORTED KINKING OF THE IMPELLA CATHETER (23FR INTRODUCER) AND GUIDEWIRE WHEN ATTEMPTING TO PASS THE IMPELLA DEVICE INTO THE PULMONARY ARTERY. THE INTRODUCER BROKE WITHIN THE PATIENT'S BODY. THE PUMP AND INTRODUCER WERE REMOVED AND REPLACED WITH A NEW PUMP/INTRODUCER. NO INTERVENTION WAS REQUIRED, AS THE INTRODUCER WAS MANUALLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WHEN USING A NEW IMPELLA AND NEW INTRODUCER. THE PROCEDURE TOOK 30 MINUTES DUE TO USING NEW DEVICES. IT WAS REPORTED THERE WAS NO KNOWN HARM OR INJURY TO THE PATIENT. THE PHYSICIAN DISCARDED THE INTRODUCER AND GUIDEWIRE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiogenic Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15076235 ↗
• MalfunctionMay 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER (MATERIAL #: (B)(4). A (B)(6) MALE WAS PRESENTED TO THE PHYSICIAN DECOMPENSATED AFTER RECENTLY RECEIVING A STENT. THE DECISION WAS MADE TO USE IMPELLA RP FOR AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK PROCEDURE. THE PHYSICIAN REPORTED BLOOD LEAKING FROM THE INTRODUCER'S VALVE AFTER REMOVING THE DILATOR. NO BLOOD TRANSFUSION WAS REQUIRED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WHEN USING A NEW 23 FR OSCOR INTRODUCER. THERE WAS NO ADDITIONAL INTERVENTION OR INJURY SUSTAINED AS A RESULT (NO HARM). THE DEVICES WERE DISCARDED BY THE PHYSICIAN.

  Patient problems: Cardiogenic Shock; Myocardial Infarction

  MAUDE report 14363604 ↗
• MalfunctionMay 4, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WE RECEIVED A COMPLAINT INVOLVING 2 CONSECTIVE OSCOR 23 FR INTRODUCERS. A (B)(6) MALE UNDERWENT A POST CARDIOTOMY CARDIOGENIC SHOCK PROCEDURE AS THE PATIENT WAS HAVING CHEST PAIN, NAUSEA AND CHRONIC HEART FAILURE. THE PHYSICIAN ALLEGED THE INTRODUCER HAD SPLIT DISTAL TO THE TIP WHEN TRACKING THE RP THROUGH THE SHEATH, ATTEMPTING TO ENTER THE INFERIOR VENA CAVA. A NEW 23 FR INTRODUCER WAS USED, ALTHOUGH THE PHYSICIAN ENDURED THE SAME FAILURE. THE PHYSICIAN NOTED STENOSIS IN THE LEFT COMMON ILIAC VEIN WAS CAUSING FRICTION BETWEEN THE INTRODUCER AND CATHETER, THUS, UNABLE TO ADVANCE THE IMPELLA INTO PROPER PLACEMENT. THERE WAS NO HARM TO THE PATIENT AND SUPPORT WAS ESCALATED TO ECMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279851 ↗
• MalfunctionApr 29, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER WAS NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER. A (B)(6) MALE PATIENT UNDERWENT A PROCEDURE FOR DECOMPENSATED POST AORTIC VALVE REPLACEMENT AND REQUIRED HEMODYNAMIC SUPPORT FROM IMPELLA RP. THE PHYSICIAN REPORTED THE INTRODUCER SPLITTING WHILE PREPARING THE PATIENT FOR RP SUPPORT. A NEW 23 FR OSCOR INTRODUCER WAS USED WITHOUT FURTHER ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254682 ↗
• InjuryMar 29, 2022Break; Crack; Break; Crack

  PATIENT WAS PRESENTED WITH RIGHT VENTRICULAR FAILURE. THE PROCEDURE WAS FOR FEMORAL VEIN INSERTION FOR PLACEMENT OF THE IMPELLA RP (RP). FIRST ATTEMPTED IMPELLA RP INSERTION FROM THE LEFT FEMORAL VEIN AND THE 23 FR SHEATH KINKED. THE KINK OCCURRED BECAUSE OF THE TORTUOSITY OF THE ILIAC ARTERY. THEN WENT TO THE RIGHT FEMORAL VEIN WITH A NEW SHEATH. X-RAY SHOWED SHEATH WAS KINKED AS WELL, BUT WERE ABLE TO PASS THE RP THROUGH IT. IT IS UNCERTAIN AS TO WHY IT SPLIT, IT WAS A STRAIGHT SHOT AND NO ISSUES WERE OBSERVED. RATHER THAN REWIRE AND ATTEMPT RE-SEAT THE RP, THE PHYSICIAN ELECTED TO PULL THE RP, PUT LARGE DILATOR IN, AND PULLED THE SPLIT SHEATH WITHOUT COMPLICATION. WHEN THE SHEATH SPLIT AND THE RP WAS NOT PLACED, THEY WENT TO THE OR FOR PLACEMENT OF OTHER SUPPORT DEVICES. IT IS BELIEVED THE PATIENT WAS THEN SENT TO SURGERY FOR CENTRIMAG/PROTEK DUO. PATIENT OUTCOME WAS REPORTED AS NO HARM. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13941095 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  DURING AN ACUTE MYOCARDIAL INFARCTION (AMI), CARDIOGENIC SHOCK (CGS) PROCEDURE, A 23FR INTRODUCER SHEATH KINKED WHEN THE PHYSICIAN WAS TRYING TO PUSH THE SHEATH INTO THE BODY UNDER FLUORO. A SECOND 23FR SHEATH WAS USED AND IT KINKED AT THE SAME SPOT WHERE THE ILIAC LOOKED CALCIFIED. THE 23FR INTRODUCERS WERE EXCHANGED FOR A GORE SHEATH. THE PATIENT PASSED AWAY IN THE INTENSIVE CARE UNIT DUE TO OVERALL HEART AND ORGAN FAILURE, DEATH NOT RELATED TO DEVICE. THE PATIENT HAD DECOMPESATED HEART FAILURE DUE TO SEVERE MITRAL REGURGITATION. ON (B)(6) 2021 THE CUSTOMER CONFIRMED DEVICE IS A 23F, BUT THE LOT NUMBER IS UNKNOWN.

  Patient problems: Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 13095401 ↗
• MalfunctionNov 10, 2021Crack; Crack

  IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE UNDERWENT A PROCEDURE TO ACCESS THE RIGHT FEMORAL VEIN FOR RP PLACEMENT. AFTER DOING SERIAL DILATION WITH THE RP INTRODUCER KIT BEFORE LOADING 23 FR DILATOR AND SHEATH ONTO 035 SUPER STIFF WIRE MD AND FIELD REP. NOTICED A CRACK IN 2 SPOTS THAT MADE A SHARP EDGE THAT COULD POTENTIALLY TEAR THE VEIN, DECIDED TO USE ANOTHER RP INTRODUCER KIT. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790701 ↗
• MalfunctionNov 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A (B)(6) MALE UNDERWENT AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK PROCEDURE. THE HOSPITAL STAFF REPORTED THAT, DURING ATTEMPTED PLACEMENT OF THE INTRODUCER, THE DEVICE TORE "NEAR THE DISTAL END OF THE DILATOR." A NEW 23 FR INTRODUCER FROM ANOTHER KIT WAS USED WITHOUT FURTHER ISSUE. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787913 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT SECOND OSCOR SHEATH FROM NEW PUMP KIT WAS USED TO COMPLETE THE PROCEDURE (LOT NUMBER UNKNOWN). THE CAUSE OF PATIENT DEATH WAS ACUTE RESPIRATORY REST FOLLOWED BY CARDIOGENIC SHOCK, AND WAS NOT ATTRIBUTED TO THE OSCOR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474860 ↗
• InjuryJul 30, 2021Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2021 DURING AN ACUTE MYOCARDIAL INFARCTION (AMI)/ CARDIOGENIC SHOCK (CGS) PROCEDURE, A 23 FR INTRODUCER SHEATH KINKED WHEN THE PHYSICIAN WAS TRYING TO PUSH THE SHEATH INTO THE BODY UNDER FLUORO. A SECOND 23 FR SHEATH WAS USED AND IT KINKED AT THE SAME SPOT. IT WAS REPORTED THE SPOT IN THE ILIAC LOOKED CALCIFIED. THE 23 FR INTRODUCERS WERE EXCHANGED FOR A GORE SHEATH. THE PATIENT PASSED AWAY IN THE INTENSIVE CARE UNIT DUE TO OVERALL HEART AND ORGAN FAILURE, DEATH NOT RELATED TO DEVICE. THE PATIENT HAD DECOMPENSATED HEART FAILURE DUE TO SEVERE MITRAL REGURGITATION.

  Patient problems: Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12256178 ↗
• InjuryJul 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT RP DILATORS WERE USED TO DILATE UP TO 23 FR, HOWEVER UNABLE TO FULLY INSERT 23 FR CATHETER. THE DILATOR WAS TAKEN OUT OF THE SHEATH AND SUCCESSFULLY INSERTED TO DILATE TRACK. REMOVED AND REINSERTED INTO 23 FR SHEATH AND INSERTED INTO LEFT GROIN OF A (B)(6) YEAR OLD FEMALE. ONCE THE DILATOR WAS REMOVED AND WIRE PLACED FOR CATHETER INSERTION, A STEADY FLOW OF BLOOD CAME OUT OF THE SHEATH AROUND THE WIRE. IMPELLA BACK LOADED ONTO WIRE AND INSERTED. HOWEVER, ONCE THE IMPELLA WAS IN THE BODY, A MASS AMOUNT OF BLOOD POURED OUT OF THE HEMOSTATIC VALVE OF IMPELLA SHEATH. SHOVED IMPELLA FORWARD AND INTO POSITION AND REMOVED WIRE AND SHEATH QUICKLY TO CONTROL BLOOD VOLUME. UNFORTUNATELY, PATIENT LOST APPROXIMATELY 800-1000 ML. RP RAMPED UP QUICKLY. SUCTION ON BOTH RP AND CP. 3 L NS GIVEN IN THE CVL WITH 2 UNITS PRBC CONTROLLED BLEEDING AT RP SITE WITH 5 MATTRESS SUTURES AND FIGURE 8 SUTURE. PATIENT CARE WITHDRAWN/PATIENT EXPIRED 06/24/2021 DUE TO MULTIPLE ORGAN FAILURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12225480 ↗

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-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