Introducer Kit for Impella® 0052-3000 (UDI 00813502011562)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00813502011562), received between Aug 2, 2017 and Nov 12, 2020 — classified as 2 deaths, 11 injuries, 6 malfunctions.

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

4 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 14FR INTRODUCER APPEARED NOT TO BE SEALED (LEAK). THE PROBLEM WAS FOUND DURING PREPARATION FOR AN ACUTE MYOCARDIAL INFARCTION (AMI)/ CARDIOGENIC SHOCK (CGS) PROCEDURE ON A (B)(6)- YEAR OLD MALE PATIENT. THE PHYSICIANS DECIDED QUICKLY TO OPEN ANOTHER IMPELLA SET FOR A NEW INTRODUCER AS THE PATIENT WAS IN VERY POOR CONDITION. THE PATIENT EXPIRED AT SOME POINT DURING, OR AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: Cardiogenic Shock; Myocardial Infarction

  MAUDE report 10828657 ↗
• InjurySep 24, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PLACEMENT OF THE IMPELLA CP TO THE RIGHT FEMORAL ARTERY, USER WAS MOVING THE PUMP THROUGH THE PEEL-AWAY INTRODUCER AND THE INTRODUCER HAS DELAMINATED IN SEVERAL SPOTS. BOTH PARTS OF THE PEEL-AWAY SHEATH HAD DETACHED FROM EACH OTHER ON THE DISTAL END CAUSING MASSIVE BLOOD LEAK. THE PUMP HAS BEEN INTRODUCED INTO THE HEART AND THE PROCEDURE WAS COMPLETED WHILE KEEPING HARD PRESSURE ON THE LEAK SPOT. DELAMINATED INTRODUCER CAUSED A MASSIVE HEMORRHAGE ON THE OUTSIDE OF THE DEVICE. THE MEDICAL STAFF HAS DECIDED TO CONTINUE THE PROCEDURE. THE HEMORRHAGE WAS LIMITED BY MAINTAINING STRONG PRESSURE. DURING SURGICAL OPERATION 3 UNITS OF RED BLOOD CELLS WERE TRANSFUSED. THE PATIENT HAD SYMPTOMS OF HEMORRHAGIC SHOCK AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10583189 ↗
• InjuryNov 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING SETUP OF THE SYSTEM, WHILE ONLY 0.18" WIRE WAS IN THE 14F INTRODUCER, BLEEDING THROUGH THE VALVE STARTED. AFTER IMPELLA PLACEMENT THE BLEEDING INCREASED. INTERVENTION NEEDED, PROCEDURE WAS RESTARTED WITH UTILIZATION OF A NEW INTRODUCER KIT DUE TO THE HEAVY BLEEDING THROUGH THE FIRST ONE DAMAGED. PROCEDURE WAS COMPLETED. NO TRANSFUSION WAS PERFORMED ON THE PATIENT. PRODUCT WAS DISCARDED.

  Patient problems: Blood Loss

  MAUDE report 9315868 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) WHITE MALE PATIENT WAS ADMITTED FOR CHRONIC TOTAL OCCLUSION OF THE CORONARY ARTERY AND THE PRODUCTS WERE USED FOR A HIGH RISK PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. WHILE ATTEMPTING TO INSERT THE INTRODUCER INTO THE PATIENT'S RIGHT FEMORAL ARTERY, THE PATIENT ENDURED A "MASSIVE VASOVAGAL REACTION" AND REQUIRED CPR, INTUBATION, AND HIGH DOSE CATECHOLAMINE'S. THE INSERTION SITE WAS CHECKED AND NO DISSECTION WAS NOTED. THE PHYSICIAN PROCEEDED TO INSERT THE INTRODUCER INTO THE LEFT FEMORAL ARTERY WITHOUT ISSUE (NO SPECIFICATION OF TIME, CHANGE TOOK PLACE VERY QUICKLY). THE IMPELLA WAS INSERTED SUCCESSFULLY, HOWEVER, THE SITE DEVELOPED A BLEED AT THE INTRODUCER. NO FURTHER INFORMATION AVAILABLE AS TO SITE OF LEAK, THERE WAS BLOOD LEAKING ORIGINATING FROM THE OUTSIDE/SURROUNDING THE INTRODUCER INSERTION SITE. THE PATIENT LOST APPROXIMATELY 500ML OF BLOOD AND REQUIRED A TRANSFUSION. BOTH THE INTRODUCER AND IMPELLA WERE REMOVED AND THE SITE WAS CLOSED WITH MANUAL COMPRESSION AND A FEMSTOP. NO NEW DEVICE WAS USED AND THE PATIENT SURVIVED. AFTER IMPLANTATION OF IMPELLA, THE PATIENT'S HEMODYNAMICS IMPROVED AND BECAME MORE STABLE. IT WAS REPORTED APPROXIMA

  Patient problems: Blood Loss

  MAUDE report 9274843 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS PRESENTED FOR ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK (AMI/CGS), WHILE INSERTING THE INTRODUCER, THERE WAS DIFFICULTY REPORTED AND AN ACCESS SITE BLEED RESULTED. INITIAL PLACEMENT WAS DIFFICULT DUE TO RESISTANCE ON VASCULAR LEVEL. (B)(6) 2012 F DILATOR HAVE BEEN USED. BLOOD TRANSFUSION AND SURGICAL REPAIR WAS REQUIRED TO CONTROL THE BLOOD LOSS. APPROXIMATELY 1500 ML BLOOD WAS LOSS. BLEEDING OCCURRED UPON ARRIVAL AT ICU, AFTER INSERTION. PHYSICIAN CANNOT DETERMINE IF THE BLEEDING WAS CAUSED BY THE INTRODUCER OR THE PATIENT'S ANATOMY. PATIENT OUTCOME IS DEATH. PATIENT WAS WITHDRAWN FROM CARE ON (B)(6) 2019 DUE TO MULTIPLE ORGAN FAILURE. DEATH IS UNRELATED TO THE DEVICE. DEVICE IS DISCARDED BY USER.

  Patient problems: Blood Loss; Death

  MAUDE report 9072545 ↗
• MalfunctionAug 9, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PATIENT WAS PRESENTED TO PHYSICIAN FOR 3 VESSEL DISEASE, EJECTION FRACTION <20%. DURING HIGH RISK PERCUTANEOUS CORONARY INTERVENTION PHYSICIAN WAS REMOVING 14FR DILATOR AND BLEEDING WAS DISCOVERED AT THE INTRODUCER'S VALVE. TO RESOLVE BLEEDING, THE DECISION WAS MADE TO ADVANCE THE IMPELLA CP INTO THE INTRODUCER. APPROXIMATELY 20ML BLOOD WAS LOST AND NO BLOOD PRODUCTS OR SURGICAL INTERVENTION REQUIRED TO CONTROL THE BLOOD LOSS. REPOSITIONING SHEATH WAS INSERTED INTO THE INTRODUCER. THEREAFTER, MANUAL COMPRESSION WAS APPLIED FOR 20 MINUTES. PHYSICIAN INITIALLY THOUGHT THERE WAS AN ARTERIAL PUNCTURE, HOWEVER, ADVISED AFTER THE INTERVENTION THAT IT WAS NOT A COMPLICATION NOR A VESSEL DAMAGE. MICRO PUNCTURE W/ECHO TECHNIQUE USED FOR INSERTION. PROCEDURE COMPLETED SUCCESSFULLY BY INTRODUCING THE REPO UNIT INTO THE 14FR INTRODUCER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8880838 ↗
• InjuryMay 1, 2019Structural Problem; Deformation Due to Compressive Stress; Structural Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PATIENT WAS PRESENTED TO PHYSICIAN IN CARDIOGENIC SHOCK. PATIENT HAS VERY COMPLEX ANATOMY AND CALCIFICATION. DURING ACCESS OF THE RIGHT FEMORAL ARTERY FOR PLACEMENT OF THE IMPELLA CP, 14FR PEELAWAY SHEATH BURST FOR A FEW MILLIMETERS BUT NO BLEEDING PROBLEMS OCCURRED. USER LEFT THE PEELAWAY SHEATH TO PREVENT BLEEDING PROBLEMS FORM THE PUNCTURE. USER PLACED 13FR MERIT SHEATH 2 CM ABOVE AND IMPLELLA 2.5 PLACED SUCCESSFULLY. THERE WAS NO BLEEDING PROBLEM OR LEG PERFUSION PROBLEM NOTICED BUT PATIENT DIED NEXT DAY BECAUSE OF MULTI ORGAN FAILURE. DATE OF DEATH IS NOT AVAILABLE. PRODUCT WAS DISCARDED. AS PER ADDITIONAL INFORMATION, PATIENT HAS VERY DIFFICULT ANATOMY, PHYSICIAN THINKS THE HE KINKED THE PEELAWAY SHEATH AND HE DON'T REMEMBER WHERE IT DOES EXACTLY KINKS AND BURST. HE REMEMBER THAT THE BURST MUST BE ROUGHLY 5MM. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 8569110 ↗
• MalfunctionApr 29, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT ON 29TH MARCH PATIENT WAS PRESENTED FOR CARDIOGENIC SHOCK. DURING ACUTE MYOCARDIAL INFARCTION PROCEDURE PHYSICIAN WAS UNABLE TO PASS PUMP THROUGH INTRODUCER AS INTRODUCER WAS KINKED AND PREVENTING PASSAGE OF IMPELLA CP. SITE WAS DILATED, INTRODUCER WAS PLACED, AND PUMP INSERTION WAS ATTEMPTED. THE PHYSICIAN ADVISED THAT NO EXCESSIVE FORCE WAS USED WHEN IMPLANTING THE INTRODUCER. PATIENT LOST 100-200 ML OF BLOOD. HOWEVER, NO BLOOD PRODUCT OR SURGICAL INTERVENTION NEEDED. KINKED INTRODUCER WAS REMOVED AND NEW INTRODUCER (OTHER BRAND) WAS USED TO COMPLETE SURGERY. AS PER ADDITIONAL INFORMATION, INTRODUCER KINKED DURING INSERTION. FOR INSERTION PHYSICIAN USED DILATOR AND NO DILATION PERFORMED. THERE WAS 10 -15 MIN DELAY REPORTED TO CHANGE INTRODUCER. DEVICE WAS NOT USED IN TORTUOUS PATH. PROCEDURE COMPLETED WITH ABIOMED 14FR X 13CM INTRODUCER, NO IMPELLA WAS USE.

  Patient problems: Blood Loss

  MAUDE report 8561739 ↗
• InjuryApr 24, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2019 PATIENT WAS PRESENTED TO PHYSICIAN WITH LOW EJECTION FRACTION (~20%). DURING PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR TRIPLE VESSEL DISEASE (TVD) REQUIRED ROTABLATION A 14 FR INTRODUCER BEING USED. AFTER INSERTING THE PUMP INTO THE SHEATH AND STARTING IMPELLA, PHYSICIAN DISCOVERED THAT THE HEMOSTATIC VALVE OF THE PEEL AWAY SHEATH IS OOZING BLOOD. AS PER PHYSICIAN RE-PO SHEATH IS SLIGHTLY IN TOUCH WITH THE SHEATH DURING IMPELLA INSERTION BUT IT SHOULDN'T CAUSE THE OOZING. PHYSICIAN IS EXPECTING TO COMPLETE THE REVASCULATION WITH IMPELLA SUPPORT. DUE TO BLOOD LOSS AND DROPPED BP, HE ABORTED THE PROCEDURE AND BLOOD TRANSFUSION PERFORMED. THEY REMOVED THE PEEL AWAY SHEATH AND INSERTED THE REPOSITIONING SHEATH TO STOP THE BLEEDING. PHYSICIAN COMPLETED ONE VESSEL AND THEY STAGE THE OTHER 2 VESSELS, BUT THEY COMPLETED RE-VAS BEFORE PATIENT DISCHARGED. ADRENALINE AND AMIODARONE USED AS MEDICAL INTERVENTION. AMOUNT OF BLOOD LOSS IS UNKNOWN AND PATIENT OUTCOME IS STABLE.

  Patient problems: Blood Loss

  MAUDE report 8544259 ↗
• MalfunctionMar 13, 2019Break; Break

  ON JULY 5, 2018 THE CUSTOMER WAS NOTIFIED THAT AN INCIDENT OCCURRED DURING A SURGICAL PROCEDURE FOR PLACEMENT OF AN IMPELLA CP ON (B)(6) 2018. THE PATIENT WAS ADMITTED FOR A HIGH RISK CORONARY ANGIOPLASTY; TURNED DOWN FOR BYPASS SURGERY. THE FIELD REP REPORTS THE HUB CAP SEPARATED DURING INSERTION, ANOTHER OSCOR INTRODUCER WAS PLACED. IT WAS REPORTED THAT DURING THE PLACEMENT OF THE SECOND INTRODUCER THERE WAS A MINIMAL PROCEDURE DELAY. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8418566 ↗
• MalfunctionMar 6, 2019Break; Break

  IT WAS REPORTED THE PATIENT WAS PRESENTED TO THE PHYSICIAN IN ACUTE MI AND CARDIOGENIC SHOCK ON (B)(6) 2019. DURING THE PROCEDURE THE SHEATH WAS PLACED IN THE RIGHT FEMORAL ARTERY. THE REPRESENTATIVE REPORTED IT WAS NOT POSSIBLE TO PLACE THE COMPETITOR'S 14FR SHEATH, DUE TO WIRE (GUIDEWIRE) INTERACTION. DAMAGE TO SHEATH OCCURRED DURING WIRE (GUIDEWIRE) REMOVAL. PHYSICIAN ATTEMPTED TO PLACE ANOTHER COMPETITOR'S 14FR PEEL-AWAY SHEATH (LENGTH SIZE IS UNKNOWN) BUT WAS NOT SUCCESSFUL. IT WAS REPORTED THERE WAS DELAY OF A FEW MINUTES IN THE SURGICAL PROCEDURE DURING EXCHANGE OF INTRODUCER. THE PATIENT RECEIVED SEVERAL DILATIONS PRIOR TO INTRODUCER PLACEMENT. IT WAS REPORTED THE ANGULATION TO PLACE THE SHEATH WAS DONE IN THE NORMAL WAY. THE PATIENT HAD NO PERIPHERAL DISEASE, NO OBESITY, BUT IT WAS VERY DIFFICULT UNDER ONGOING CPR TO PUNCTURE THE ARTERIA. PATIENT OUTCOME WAS DEATH. THE PHYSICIAN REPORTED CAUSE OF DEATH AS MULTI ORGAN FAILURE, PATIENT EXPIRED ON (B)(6) 2019.

  Patient problems: Multiple Organ Dysfunction Syndrome; Myocardial Infarction

  MAUDE report 8396865 ↗
• InjuryFeb 1, 2019Break; Break

  IT WAS REPORTED THAT DURING ACCESS AT FEMORAL ARTERY INTRODUCER BREAK INTO 4 PIECES WHICH PROMOTED VASCULAR REPAIR. PATIENT SURVIVED AFTER SURGERY. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. NO OTHER ADVERSE EVENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8298432 ↗
• InjuryJan 10, 2019Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING PLACEMENT OF IMPELLA CP, SHEATH BROKE TO 4 PIECES IN THE PATIENT. AS PER ADDITIONAL INFORMATION, SHEATH WAS TORN AND THERE WERE 4 OR 5 LONGITUDINAL CRACKS. PATIENT LOSS OF 2 LITER BLOOD IN CATH LAB, AS RESULT 14 UNITS OF BLOOD TRANSFUSION PERFORMED. TO PREVENT THE BLOOD LOSS ACCESS SITE WAS TREATED BY 25 MINUTE OF MANUAL COMPRESSION AND AFTER THAT VASCULAR SURGEON SUTURED THE PUNCTURE SITE. THE PROCEDURE IS ABORTED AND PATIENT WAS SUPPORTED BY VA ECMO. NO ADDITIONAL INFORMATION IS AVAILABLE AND NO OTHER ADVERSE EVENT WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8237479 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS ADMITTED FOR HIGH RISK ANGIOPLASTY. DURING THE ACCESS AT THE FEMORAL ARTERY FOR PLACEMENT OF THE IMPELLA CP, 150CC OF BLOOD LOST NOTED WHICH PROMPTED PLACEMENT OF A NEW 14FR X13CM INTRODUCER. THERE WAS NO SURGICAL INTERVENTION OR BLOOD PRODUCTS REQUIRED TO CONTROL THE BLOOD LOSS. ANGIOPLASTY PROCEDURE WAS DONE WITH IMPELLA SUPPORT. HOWEVER, THERE WAS NO PRODUCT PROBLEM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AND NO OTHER ADVERSE EVENT WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8226575 ↗
• InjuryDec 13, 2018Difficult to Advance; Difficult to Advance

  VISUAL INSPECTION OF RETURN DEVICE SHOWS THAT SHEATH WAS SPLIT UP, ONE OF THE SCORELINES APPROXIMATELY 11.5CM FROM THE DISTAL TIP.

  Patient problems: Blood Loss; Rupture

  MAUDE report 8160019 ↗
• MalfunctionJun 28, 2018Crack; Crack

  IT WAS REPORTED THAT AN INCIDENT WHICH INVOLVED A 14FX13 CM INTRODUCER OCCURRED DURING A PLANNED HIGH RISK PERCUTANEOUS CORONARY INTERVENTION PROCEDURE ON (B)(6) 2018. DURING INSERTION AT THE LEFT FEMORAL ARTERY, AFTER DILATIONS WITH 8F, 10F, AND 12F THE 14FR INTRODUCER CRACKED. THE PHYSICIAN CONDUCTED THE FIRST THREE DILATIONS, PUT THE 14FX13 INTRODUCER OVER THE .035 STIFF WIRE, IT CRACKED, WAS REMOVED AND A NEW 14FX13 INTRODUCER WAS PLACED. PER THE REPORTER, THE TIP OF THE SHEATH IS WHAT SPLIT DOWN AND ALONG THE LENGTH TO THE MIDDLE PORTION. THERE WAS ROUGHLY 30 CC OF BLOOD LOST DURING THE SWITCH TO 2ND REPLACEMENT 14FX13 OSCOR SHEATH. PATIENT IS REPORTED TO BE STABLE AND NO EXTENDED HOSPITALIZATION WAS REQUIRED. THE PRODUCT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7648109 ↗
• DeathJan 23, 2018Break; Break

  1. WHAT IS THE DATE OF EVENT? (B)(6) 2018. 2. WHAT IS THE NAME OF THE FACILITY WHERE EVENT OCCURRED? (B)(6). 3. WHAT IS THE OUTCOME OF THE PATIENT? (E.G. PATIENT STABLE, PATIENT ALIVE, NO INJURY, SERIOUS INJURY, DEATH) DEATH. 4. WHAT PROCEDURE WAS THE PRODUCT USED FOR? INSERTION VIA THE LEFT FEMORAL ARTERY OF THE IMPELLA CP. 5. WHAT WAS THE CONDITION OF THE PATIENT WHEN PRESENTED TO THE PHYSICIAN? PATIENT WAS IN CARDIOGENIC SHOCK BEING SUPPORTED BY VA ECMO. 6. WAS THERE AN ISSUE WITH THE PRODUCT ? IF YES , THEN PROVIDE DETAILS OF THE ISSUE AND ANSWER THE QUESTIONS A) AND B). YES. A. WHEN WAS THE ISSUE IDENTIFIED? (BEFORE , DURING OR AFTER THE PROCEDURE) DURING IMPLANT OF THE IMPELLA CP THE TEAM NOTICED THE 14FR PEEL AWAY SHEATH WAS BROKEN/CUT SIDEWAYS. B. WHAT WAS THE USER (PHYSICIAN/ DOCTOR/ NURSE) DOING WHEN THE ISSUE OCCURRED? PENDING MORE DETAILS. 7. PLEASE PROVIDE THE CONTACT INFORMATION OF THE PHYSICIAN WHO USED THE PRODUCT TO OBTAIN ADDITIONAL CLINICAL INFORMATION OF THE EVENT IN QUESTION. N/A. 8. WHAT IS THE MODEL NUMBER AND LOT NO. OF THE DEVICE USED? C1-13834. 9. WAS THERE ANY ADDITIONAL DEVICES USED DURING THE PROCEDURE? WHEN THE FIRST OSCOR WAS SEEN TO BE BROKEN, A SECO

  Patient problems: Cardiogenic Shock; Death

  MAUDE report 7211751 ↗
• DeathOct 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CASE INFORMATION: (B)(6) YEAR OLD MALE WITH STEMI BROUGHT TO THE HOSPITAL. FEMORAL ANGIOGRAM PERFORMED PRIOR TO SHEATH INSERTION SHOWING SUFFICIENT VESSEL SIZE. THE 14 FR OSCOR INTRODUCER SHEATH WAS INSERTED IN THE RFA. ILIAC DISSECTION WAS NOTED POST SHEATH INSERTION WITH ANGIOGRAM. IMPELLA INSERTION WAS ABORTED. THE PATIENT DID NOT SURVIVE. THE SHEATH WAS TAKEN AWAY WITH PATIENT AND COULD NOT BE RETRIEVED. WE WILL NOT BE RECEIVING THIS PRODUCT BACK, SO THIS WILL BE ALL THE INFORMATION WE WILL BE GETTING REGARDING THE CASE.

  Patient problems: Myocardial Infarction

  MAUDE report 6948640 ↗
• InjuryAug 2, 2017Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  THE COMPLAINANT REPORTED THAT AN (B)(6) FEMALE PATIENT WITH 3-VESSEL DISEASE WAS SCHEDULED TO HAVE A SUBACUTE PCI TO BE PERFORMED ON (B)(6) 2017 WITH THE AID OF AN IMPELLA CP. GOOD LOCAL ARTERIAL PULSATION WAS FOUND IN BOTH GROINS. A STANDARD 6F FEMORAL SHEATH WAS INSERTED INTO THE RIGHT FEMORAL ARTERY AND ILIACOGRAPHY SHOWED BOTH ILIAC ARTERIES AS GOOD CALIBER. A STANDARD 6FR FEMORAL SHEATH WAS INSERTED INTO THE LEFT FEMORAL ARTERY. 5000 IU OF HEPARIN WAS ADMINISTERED INTRA-ARTERIALLY. A LONG STANDARD J-WIRE WAS ADVANCED TO THE AORTIC ARCH. THE SHEATH WAS THEN REMOVED FROM THE LEFT GROIN AND THE IMPELLA CP ARTERIAL DILATORS WERE USED WITH NO RESISTANCE. THE IMPELLA PEEL-AWAY INTRODUCER WAS INSERTED INTO THE ARTERY. THE WIRE MOVED FREELY, BUT FOLLOWING THE REMOVAL OF THE INTRODUCER DILATOR THERE WAS NO ARTERIAL FLOW IN THE SHEATH. THE PATIENT IMMEDIATELY DETERIORATED INTO SHOCK DUE TO SEVERE BLEEDING FROM THE LEFT FEMORAL ARTERY, AND WAS QUICKLY INTUBATED AND VENTILATED. THE COMPLAINANT REPORTED THAT DURING THE INSERTION OF THE INTRODUCER IT ACCIDENTLY PEELED AND DAMAGED THE VESSEL WALL, REQUIRING SURGICAL REPAIR. DURING THE SURGICAL PROCEDURE THE PATIENT WAS ADMINISTERED 6 UNITS O

  Patient problems: Angina; Blood Loss; Calcium Deposits/Calcification

  MAUDE report 6761331 ↗

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-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