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AVANTI 504606XRecalls & reported problems

Cordis Corporation · SI AVANTI+ 6F STD W/GW NO OBT · Class 2

All models of AVANTI (19)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
19
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705032010054), received between Apr 8, 2019 and Feb 6, 2026 — classified as 8 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (K970392); 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component11
  • Device Contamination with Chemical or Other Material2
  • Manufacturing, Packaging or Shipping Problem2
  • Partial Blockage2
  • Stretched2
  • Unraveled Material2
  • Adverse Event Without Identified Device or Use Problem1
  • Difficult to Open or Remove Packaging Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions10
  • No Consequences Or Impact To Patient6
  • Hematoma1
  • Injury1
  • No Code Available1

Recent adverse event reports

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

  • MalfunctionFeb 6, 2026Detachment of Device or Device Component

    AS REPORTED, A PORTION OF A 6F AVANTI PLUS STD 11CM .038-INCH INTRODUCER FRACTURED DURING SHEATH REMOVAL AND REMAINED INSIDE THE PATIENT DURING AN ELECTROPHYSIOLOGY PROCEDURE. THE RETAINED FRAGMENT WAS SUBSEQUENTLY REMOVED BY VASCULAR SURGERY. THERE WAS NO REPORTED PATIENT INJURY. THE LOT IS UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24281001 ↗
  • MalfunctionNov 7, 2025Fracture; Stretched; Unraveled Material; Fracture; Stretched; Unraveled Material

    AS REPORTED, THE ASSEMBLED DILATOR AND SHEATH OF A 6F 11CM AVANTI+ INTRODUCER COULD NOT PASS OVER THE SHORT GUIDEWIRE. A NEW SHEATH WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE HAD BEEN INTENDED FOR USE DURING AN ANGIOGRAPHY PROCEDURE. AFTER PUNCTURE, A SHORT GUIDEWIRE WAS INSERTED, AND THE DILATOR AND SHEATH ASSEMBLY WERE ADVANCED ALONG THE SHORT GUIDEWIRE BEFORE THE ISSUE OCCURRED. A CONTRALATERAL APPROACH WAS NOT USED, AND THE ACCESS SITE VESSEL WAS NORMAL WITHOUT CALCIFICATION OR TORTUOSITY. THE DEVICE WAS FLUSHED BEFORE USE, AND THE DILATOR WAS SNAPPED INTO PLACE AT THE HUB. DURING THE PROCEDURE, ONLY THE REPORTED PRODUCT NEEDED REMOVAL. NO ADDITIONAL DAMAGES WERE NOTED TO THE DEVICE, THE WIRE, OR THE PACKAGING. THE DEVICE WAS STORED AND PREPARED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PE FINDINGS, THE MINI GUIDEWIRE IS UNRAVELED AND SEPARATED ON THE DISTAL END.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23504352 ↗
  • InjuryJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED, WHEN REMOVING OF A 6F 11CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) DURING AN ELECTROPHYSIOLOGY (EP) HIS SYNSCOPES PROCEDURE, THE DEVICE BROKE, AND PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE REST OF THE CSI WAS REMOVED FROM THE PATIENT WITH A NON-CORDIS LASSO. THE PROCEDURE LASTED LONGER THAN EXPECTED AND THE PATIENT REQUIRED OCCLUSIVE COMPRESSION AND A RE-ABSORBABLE SUTURE TO ACHIEVE HEMOSTASIS, AS WELL AS HOSPITALIZATION WITH DOPPLER CONTROL. A 22-GAUGE NEEDLE WAS USED DURING INTRODUCTION INTO THE PATIENT¿S RIGHT FEMORAL VEIN OF THE SUPERIOR RIGHT MEMBER. THE PATIENT WAS IN THE DECUBITO-DORSAL POSITION DURING THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21102475 ↗
  • MalfunctionSep 26, 2024Partial Blockage; Partial Blockage

    MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE WAS NOT RETURNED AS ANTICIPATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20309175 ↗
  • MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED, THE SIDE PORT OF A 6F 11 CM AVANTI PLUS SHEATH INTRODUCER WITH MINI-GUIDEWIRE BECAME DISCONNECTED (CAME OFF) RESULTING IN BLOOD ALL OVER THE BED. THE PATIENT HAD AN ESTIMATED BLOOD LOSS OF 40-50 CC. THIS WAS NOTICED BY THE NURSE BEFORE PULLING THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19838824 ↗
  • MalfunctionJan 18, 2024Stretched; Unraveled Material; Stretched; Unraveled Material

    AS REPORTED, THE GUIDEWIRE OF AN 6F 11CM AVANTI + SHEATH INTRODUCER DID NOT ENTER SMOOTHLY INTO THE NEEDLE THAT HAD ENTERED THE BLOOD VESSEL. THEN THE OPERATOR PULLED OUT THE WIRE. WHEN THE WIRE CAME OUT, THE CONDITION OF THE WIRE WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT INJURY. THE PATIENT WAS UNDERGOING A CORONARY ARTERY BYPASS GRAFT (CABG). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.ADDENDUM: PER THE PICTURE ANALYSIS, THE MINI GUIDEWIRE WAS UNRAVELED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18536911 ↗
  • MalfunctionNov 2, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

    AS REPORTED, UPON OPENING, A 6F STANDARD AVANTI + SHEATH INTRODUCER WITH .038-INCH GUIDEWIRE WAS FOUND TO BE ABNORMALLY PACKAGED BY THE "SEALING RING OPENING" ON THE OUTER BAG. THERE WERE NO REPORTS OF PATIENT INJURY. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18056268 ↗
  • InjuryApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED, THERE WAS A PROBLEM WITH A 6F AVANTI + SHEATH DURING A POST ABLATION PROCEDURE. WHEN REMOVING THE SHEATH, WE ONLY HAVE A SMALL PART OF IT. IT IS BELIEVED THAT 9.5-10 CM IS STILL IN THE PATIENT. THE PATIENT IS STABLE AND WENT TO CT. THE ABLATION CASE WAS COMPLETED, AND THE PATIENT WAS BROUGHT TO SURGERY. SURGERY WAS ABLE TO REMOVE 9-10 CM OF THE SHEATH FROM THE PATIENT. IT IS UNKNOWN IF THE SHEATH WAS ABLATED BY THE PHYSICIAN. THE SHEATH WAS STORED IN THE LAB IN NORMAL TEMPERATURES. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS PREPPED PER THE IFU AND NO DIFFICULTY WAS EXPERIENCED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ONE PICTURE RELATED TO THE REPORTED FAILURE WAS ATTACHED. THE PICTURE SHOWS THE PROXIMAL SECTION OF A 6F CSI PRODUCT, THE CANNULA IS BROKEN/SEPARATED. NO OTHER ANOMALIES OF THE PRODUCT CAN BE NOTICED AT THE ATTACHED PICTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16794446 ↗
  • InjuryFeb 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED, AN 6F AVANTI+ WITH MINI-GUIDEWIRE CATHETER SHEATH INTRODUCER (CSI) RUPTURED WHEN THE CATHETER WAS REMOVED. THE MATERIAL WAS RECOVERED AFTER NEW VENA PUNCTURE USING AN UNKNOWN LASSO. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16404887 ↗
  • InjurySep 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED, A SMALL HAEMATOMA DEVELOPED ABOUT FIVE MINUTES AFTER USING A 6/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) AFTER THE PROCEDURE. COMPRESSION AND A PRESSURE BANDAGE WAS USED ON THE ARE AND THE PATIENT WAS FINE AND WAS DISCHARGED. TWO DAYS AFTER THE PROCEDURE, THE PATIENT WENT TO A RESTAURANT FOR DINNER AND APPARENTLY, HE STARTED TO COMPLAIN OF A PAIN IN HIS LEG. THE PATIENT WENT TO THE HOSPITAL¿S EMERGENCY UNIT AND THERE THEY OBSERVED A HUGE HAEMATOMA IN HIS LEG AROUND THE PUNCTURE SITE. THE SIZE OF THE HEMATOMA WAS ABOUT 10 CM AFTER THE PROCEDURE. A 6F CORDIS AVANTI SHEATH WAS USED. INITIALLY, THE PHYSICIAN DID AN ANGIOGRAM PROCEDURE ON THE PATIENT AND SAW THAT THE PATIENT HAD A PREVIOUS AORTA ANEURISM REPAIR. THEY USED A FEW CATHETERS DURING THE PROCEDURE TO BE ABLE TO ENGAGE INTO ALL THE ARTERIES. IT WAS ALSO OBSERVED THAT THE PATIENT HAD VERY HIGH SYSTOLIC BLOOD PRESSURE. THE PHYSICIAN THEN PLACED THE MYNX CONTROL CLOSURE DEVICE IN THE PUNCTURE SITE. THE PRODUCT WAS STORED AND OPENED IN THE DESCRIBED WAY AND THE CHECK OF THE BALLOON, AND THE INDICATOR WAS ALSO DONE BEFORE THEY STARTED THE PROCEDURE. EVERYTHING WAS GOOD. THE PHYSICIAN PLACED THE DEVICE IN THE DESCR

    Patient problems: Hematoma

    MAUDE report 15353739 ↗
  • InjuryFeb 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    WHEN ASSEMBLING A 6F STANDARD (STD) WITH GUIDEWIRE (W/GW) NO OBTURATOR (OBT) AVANTI PLUS CATHETER SHEATH INTRODUCER, IT WAS FOUND THAT THE HEAD-END OF THE CATHETER WAS SEPARATED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS EXCHANGED FOR ANOTHER UNKNOWN DEVICE AND THE PROCEDURE WAS COMPLETED. THE DEVICE PACKAGE WAS NOT DAMAGED IN ANY WAY. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NOTHING UNUSUAL NOTED ABOUT THE SHEATH PRIOR TO USE. THE DEVICE WILL BE RETURNED FOR EVALUATION. THERE WAS NO ADVERSE EVENT WITH THIS REPORTED ISSUE, HOWEVER, THE HOSPITAL HAS CHOSEN TO REPORT THIS AS AN ADVERSE EVENT TO THE NATIONAL MEDICAL PRODUCT ADMINISTRATION (NMPA) DIRECTLY. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11298363 ↗
  • MalfunctionSep 11, 2020Partial Blockage; Partial Blockage

    AS REPORTED, THE 6F .072 4 X 100CM EXTRA BACK-UP (XB) ADROIT GUIDING CATHETER DID NOT FIT INTO THE 6F AVANTI PLUS SHEATH INTRODUCER (SI). THE PATIENT WAS FINE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PREP ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE ACCESS SITE WAS FEMORAL. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THEY DID NOT USE A CONTRALATERAL APPROACH. VESSEL CHARACTERISTICS ACCESSING TARGET SITE IS UNKNOWN. THE DEVICE WAS NOT USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THE DEVICE KINK OR BEND DURING USE PRIOR TO THE RESISTANCE /FRICTION. THE INSERTION DIFFICULTY COULD HAVE BEEN CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. THE DIFFICULTY WAS ENCOUNTERED WHEN ADVANCED THROUGH A CORDIS CATHETER SHEATH INTRODUCER. NO PRODUCTS WERE SUCCESSFULLY USED WITH THE DEVICE AFTER THE ENCOUNTERED RESISTANCE. ONLY THE REPORTED PRODUCT WAS REMOVED, ALL CONCOMITANT PRODUCTS WERE NOT REMOVED TOGETHER. THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WERE NOT RESTERILIZED. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10521077 ↗
  • InjuryJul 9, 2020Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

    AS REPORTED VIA A VOLUNTARY MEDWATCH, A PATIENT WAS UNDERGOING DECANNULATION FROM EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND UPON REMOVAL OF THE ANTEGRADE PERFUSION SHEATH, THE HUB OF THE SHEATH BROKE OFF AND A 10 CM SEGMENT OF THE 6F AVANTI + ARTERIAL SHEATH INTRODUCER WAS RETAINED IN THE SUPERFICIAL FEMORAL ARTERY. GROIN EXPLORATION WAS UNDERTAKEN BY THORACIC SURGERY. HOWEVER, UPON EXPOSING THE ARTERY IT WAS FOUND THAT THE SHEATH HAD MIGRATED DOWN TO THE RIGHT BELOW KNEE POPLITEAL ARTERY. VASCULAR SURGERY WAS CONSULTED FOR THE REMOVAL OF THE SEGMENT OF THE SHEATH. NO ADDITIONAL INFORMATION IS AVAILABLE AND THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Code Available

    MAUDE report 10250252 ↗
  • InjuryJun 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED, 6F AVANTI PLUS STANDARD (STD) WITH GUIDEWIRE (W/GW) NO OBTURATOR (OBT) CATHETER SHEATH INTRODUCER (CSI) WAS BROKEN AND THE PART OF IT WAS STILL IN THE GROIN. A VASCULAR SURGERY TOOK THE PATIENT FOR EXPLORATION AND THE FRAGMENT OF RETAINED 10 CM SEGMENT OF THE ANTEGRADE ARTERIAL SHEATH WAS REMOVED AT THE RIGHT POPLITEAL ARTERY. THE CATHETER SEGMENT WAS ABLE TO BE REMOVED WITHOUT ANY FURTHER ISSUES. THE PATIENT'S GROINS WERE PREPPED AND DRAPED. AFTER THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS DECANNULATED, THE VENOUS CANNULA WAS REMOVED, AND PRESSURE WAS APPLIED. THE DISTAL PERFUSION CANNULA WAS REMOVED, FOLLOWED BY THE ARTERIAL CANNULA. ALL CANNULAS WERE CLAMPED AS THE SURGEON ATTEMPTED TO REMOVE THE DISTAL PERFUSION CANNULA. THE SEGMENT OF THE REMOVED FRAGMENT OF THE SHEATH HAD ONE END WHICH WAS TAPERED AND THE OTHER END WHICH WAS JAGGED CONSISTENT WITH THE BROKEN END OF THE SHEATH. THERE WERE NO ADDITIONAL FRAGMENTS VISUALIZED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10153362 ↗
  • MalfunctionJun 10, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

    AS REPORTED, IT WAS NOTED THAT THERE ARE DROPS OF FLUID INSIDE THE STERILE PACKAGE OF A 5F AVANTI PLUS STANDARD (STD) SHEATH INTRODUCER. IT IS NOTED THAT IT IS A CONDENSE WATER AND IT IS MOSTLY THE EXPLANATION. THERE WAS NO REPORTED PATIENT INJURY. NO DAMAGES WERE NOTED TO PACKAGING OF THE DEVICE. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. AN IMAGE HAS BEEN ATTACHED FOR REVIEW.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10140699 ↗
  • MalfunctionJun 10, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

    AS REPORTED, IT WAS NOTED THAT THERE ARE DROPS OF FLUID INSIDE THE STERILE PACKAGE OF A 5F AVANTI PLUS STANDARD (STD) SHEATH INTRODUCER. IT IS NOTED THAT IT IS A CONDENSE WATER AND IT IS MOSTLY THE EXPLANATION. THERE WAS NO REPORTED PATIENT INJURY. NO DAMAGES WERE NOTED TO PACKAGING OF THE DEVICE. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. AN IMAGE HAS BEEN ATTACHED FOR REVIEW.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10139874 ↗
  • MalfunctionApr 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED, THE 6F STANDARD (STD) AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) WITH GUIDEWIRE (GW) NO OBTURATOR (OBT) SNAPPED INSIDE THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND THE CANNULA WAS RECEIVED SEPARATED AT 1.9 CM FROM THE HUB, THE OTHER PORTION OF THE SEPARATED PART WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10002833 ↗
  • InjuryMay 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    DURING A TRANSCATHETER AORTIC VALVE INTERVENTION , PART OF THE AVANTI SHEATH SEPARATED IN THE PATIENT AND THE PIECE OF THE SHEATH COULD NOT BE RETRIEVED. THE PATIENT WAS SENT TO SURGERY TO SUCCESSFULLY RETRIEVE THE SEPARATE PIECE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL OR DAMAGES NOTED ABOUT THE SHEATH PRIOR TO USE. THERE WAS NO DIFFICULTY ENCOUNTERED DURING INSERTION. AFTER POSITIONING THE INTRODUCER, IT IS REPLACED BY ONE WITH A LARGER DIAMETER, BUT DURING REMOVAL, THE INTRODUCER DOES NOT RETRACT. AFTER APPLYING GREATER FORCE, THE DEVICE BROKE AND PARTS OF THE SHEATH WAS LEFT IN THE ARTERY. ATTEMPTS WERE MADE TO RECOVER THE PIECES BUT IT WAS IMPOSSIBLE. THE PIECES WERE RECOVERED WITH SURGICAL ACCESS. THE PROCEDURE WAS THEN PERFORMED WITHOUT FURTHER COMPLICATIONS. LOCAL QRA COMMENT: THE CAH CUSTOMER WHO REPORTED THE ISSUE IS A COMPANY RESELLING CORDIS PRODUCTS TO SOME HOSPITALS IN (B)(6) (ACCOUNT NAME: (B)(6)). THE ACCOUNT NUMBER SPECIFIED WITHIN THE CIF IS ASSOCIATED WITH (B)(6) AS THERE IS NO ACCOUNT NUMBER AVAILABLE SPECIFICALLY FOR THE ACTUAL HOSPITAL WHERE THE EVENT OCCURRED ((B)(6)). HOWEV

    Patient problems: Injury

    MAUDE report 8657953 ↗
  • MalfunctionApr 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    DURING USE, THE SIDE PORT ARM OF THE AVANTI SHEATH HAD DISCONNECTED FROM THE SHEATH CAUSING EXCESS BLOOD FLOW FROM SHEATH AFTER INSERTION. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8493366 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970392. One submission often covers many models, so check the product and lot details in each record.

  • Z-2079-2021 · Jun 9, 2021 · Terminated
    Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
  • Z-1174-2016 · Dec 31, 2015 · Terminated
    CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneo

Other DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION devices

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Sources and updates

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