AVANTI 504605XRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705032009980), received between Jan 10, 2020 and Sep 11, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Device Contamination with Chemical or Other Material

  As reported, during the product nationalization process of a 5F 11cm Avanti Plus catheter sheath introducer (CSI), an unknown material was identified inside of the packaging, resembling a strand of hair. There were no reported patient injuries. The device will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734363 ↗
• MalfunctionJun 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE ENTIRE HUB OF A 5F 11CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) SNAPPED OFF THE CANNULA OF THE SHEATH WHILE BEING USED FOR INSERTION IN THE FEMORAL ARTERY. A NEW 5F AVANTI PLUS CSI WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED DURING THE INSERTION PROCESS. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: THE DILATOR FOR THE 5F 11CM AVANTI PLUS CSI WAS RETURNED WITH A SEPARATED HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632735 ↗
• MalfunctionMay 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER INSERTION, THE HUB ON A 5F AVANTI SHEATH INTRODUCER POPPED OFF, AND WHILE PUTTING THE CAP BACK ON, THE CAP SPLIT. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382429 ↗
• InjuryMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THREE 5F AVANTI + SHEATH INTRODUCERS, IN A ROW, WERE FOUND TO BE VERY BRITTLE AND SNAPPED OFF INSIDE THE PATIENT. THE HUB BROKE OF THE DILATOR OF A 5F AVANTI + SHEATH INTRODUCER. IT WAS THEN THROWN AWAY. A NEW 5F AVANTI SHEATH WAS USED AND PROCEEDED WITH THE CASE, HOWEVER, WHEN THE PHYSICIAN WENT TO REMOVE THE DILATOR FROM THE SHEATH, THE HUB BROKE OFF. THEY WERE ABLE TO INSERT A WIRE AND REMOVE THE SHEATH AND DILATOR ENTIRELY. AN ADDITIONAL SHEATH WAS OPENED TO CHECK INTEGRITY AND IT ALSO SNAPPED AT THE DILATOR. THERE WERE NO REPORTS OF PATIENT INJURY. THREE CATHETERS WERE AT THE TABLE BUT ONLY ONE WAS INSERTED IN PATIENT. ALL 5 DEVICES FROM LOT WERE PULLED. THIS DEVICE WAS USED FOR AN EP ABLATION. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE INSERTING THE DILATOR. HOWEVER, THERE WAS DIFFICULTIES WHILE REMOVING THE DILATOR. WHEN THE HUB OF THE VESSEL DILATOR OF THE SHEATH BROKE OFF IN THE PATIENT, THE PHYSICIAN WAS ABLE TO ADVANCE A WIRE AND REMOVE IN WHOLE. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE REMOVING DEVICES THROUGH THE SHEATH. THERE WAS NO EXCESS FORCE USED WITH THE

  Patient problems: Insufficient Information

  MAUDE report 18959204 ↗
• InjuryMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THREE 5F AVANTI + SHEATH INTRODUCERS, IN A ROW, WERE FOUND TO BE VERY BRITTLE AND SNAPPED OFF INSIDE THE PATIENT. THE HUB BROKE OF THE DILATOR OF A 5F AVANTI + SHEATH INTRODUCER. IT WAS THEN THROWN AWAY. A NEW 5F AVANTI SHEATH WAS USED AND PROCEEDED WITH THE CASE, HOWEVER, WHEN THE PHYSICIAN WENT TO REMOVE THE DILATOR FROM THE SHEATH, THE HUB BROKE OFF. THEY WERE ABLE TO INSERT A WIRE AND REMOVE THE SHEATH AND DILATOR ENTIRELY. AN ADDITIONAL SHEATH WAS OPENED TO CHECK INTEGRITY AND IT ALSO SNAPPED AT THE DILATOR. THERE WERE NO REPORTS OF PATIENT INJURY. THREE CATHETERS WERE AT THE TABLE BUT ONLY ONE WAS INSERTED IN PATIENT. ALL 5 DEVICES FROM LOT WERE PULLED. THIS DEVICE WAS USED FOR AN EP ABLATION. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE INSERTING THE DILATOR. HOWEVER, THERE WAS DIFFICULTIES WHILE REMOVING THE DILATOR. WHEN THE HUB OF THE VESSEL DILATOR OF THE SHEATH BROKE OFF IN THE PATIENT, THE PHYSICIAN WAS ABLE TO ADVANCE A WIRE AND REMOVE IN WHOLE. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE REMOVING DEVICES THROUGH THE SHEATH. THERE WAS NO EXCESS FORCE USED WITH THE

  Patient problems: Insufficient Information

  MAUDE report 18958976 ↗
• InjuryMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THREE 5F AVANTI + SHEATH INTRODUCERS, IN A ROW, WERE FOUND TO BE VERY BRITTLE AND SNAPPED OFF INSIDE THE PATIENT. THE HUB BROKE OF THE DILATOR OF A 5F AVANTI + SHEATH INTRODUCER. IT WAS THEN THROWN AWAY. A NEW 5F AVANTI SHEATH WAS USED AND PROCEEDED WITH THE CASE, HOWEVER, WHEN THE PHYSICIAN WENT TO REMOVE THE DILATOR FROM THE SHEATH, THE HUB BROKE OFF. THEY WERE ABLE TO INSERT A WIRE AND REMOVE THE SHEATH AND DILATOR ENTIRELY. AN ADDITIONAL SHEATH WAS OPENED TO CHECK INTEGRITY AND IT ALSO SNAPPED AT THE DILATOR. THERE WERE NO REPORTS OF PATIENT INJURY. THREE CATHETERS WERE AT THE TABLE BUT ONLY ONE WAS INSERTED IN PATIENT. ALL 5 DEVICES FROM LOT WERE PULLED. THIS DEVICE WAS USED FOR AN EP ABLATION. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE INSERTING THE DILATOR. HOWEVER, THERE WAS DIFFICULTIES WHILE REMOVING THE DILATOR. WHEN THE HUB OF THE VESSEL DILATOR OF THE SHEATH BROKE OFF IN THE PATIENT, THE PHYSICIAN WAS ABLE TO ADVANCE A WIRE AND REMOVE IN WHOLE. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE REMOVING DEVICES THROUGH THE SHEATH. THERE WAS NO EXCESS FORCE USED WITH THE

  Patient problems: Insufficient Information

  MAUDE report 18958836 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DILATOR OF A 5F AVANTI PLUS SHEATH INTRODUCER WITH MINI-GUIDEWIRE BROKE WHEN THE DOCTOR PUT IT IN THE PATIENT. THE DOCTOR TRIED AGAIN WITH A SECOND 5F AVANTI SHEATH OF THE SAME LOT AND THE SAME ISSUE OCCURRED. THERE WAS NO REPORTED PATIENT INJURY. FEMORAL ACCESS WAS USED. THE INTENDED PROCEDURE WAS NOT PROVIDED. IT IS UNKNOWN HOW THE PHYSICIAN REMOVED THE DILATOR. TWO (2) DEVICE PICTURES WERE RECEIVED FOR REVIEW. IMAGES ATTACHED TO EVENT SHOW TWO DILATORS, WHICH HAVE BEEN SEPARATED AT THE PROXIMAL END. THERE WERE NO ABNORMALITIES NOTED ON THE PRODUCT OR PRODUCT PACKAGE. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849974 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DILATOR OF A 5F AVANTI PLUS SHEATH INTRODUCER WITH MINI-GUIDEWIRE BROKE WHEN THE DOCTOR PUT IT IN THE PATIENT. THE DOCTOR TRIED AGAIN WITH A SECOND 5F AVANTI SHEATH OF THE SAME LOT AND THE SAME ISSUE OCCURRED. THERE WAS NO REPORTED PATIENT INJURY. FEMORAL ACCESS WAS USED. THE INTENDED PROCEDURE WAS NOT PROVIDED. IT IS UNKNOWN HOW THE PHYSICIAN REMOVED THE DILATOR. TWO (2) DEVICE PICTURES WERE RECEIVED FOR REVIEW. IMAGES ATTACHED TO EVENT SHOW TWO DILATORS, WHICH HAVE BEEN SEPARATED AT THE PROXIMAL END. THERE WERE NO ABNORMALITIES NOTED ON THE PRODUCT OR PRODUCT PACKAGE. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849936 ↗
• InjurySep 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE IN WHICH A 5F 11CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) WAS USED, A COMPONENT OF THE CSI BROKE OFF AND MIGRATED INTO RIGHT ATRIUM (RA) OF THE PATIENT. THE SEPARATED CSI SEGMENT WAS NOT NOTICED DURING THE PROCEDURE BUT WAS OBSERVED AT SOME POINT AFTER THE PROCEDURE VIA MEDICAL IMAGING. A SECOND OPERATION WAS PERFORMED IN ORDER TO SUCCESSFULLY REMOVE THE SEPARATED CSI SEGMENT FROM THE PATIENT. THE INITIAL PROCEDURE WAS A PULMONARY DILATATION IN WHICH THE AVANTI PLUS CSI WAS INSERTED INTO THE FEMORAL VEIN. THERE WASN'T ANY RESISTANCE BETWEEN THE AVANTI PLUS CSI AND ANY OF THE CONCOMITANT DEVICES USED DURING THIS PROCEDURE. THERE WERE NO ISSUES REMOVING ANY OF THE CONCOMITANT DEVICES FROM THE AVANTI PLUS CSI. THE CSI WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY INSERTING THE DEVICE. ONLY THE SEPARATED CSI SEGMENT WILL BE RETURNED RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692501 ↗
• InjuryNov 10, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, AT THE END OF THE PROCEDURE WHEN REMOVING A 5F WITH GUIDEWIRE AVANTI+ CATHETER SHEATH INTRODUCER (CSI) THE PHYSICIAN NOTICED RESISTANCE. THE SHEATH WAS REMOVED UNDER RESISTANCE AND HAD TORN OFF. THE SHEATH WAS PREVIOUSLY FIXED WITH A Z-SEAM (SUTURE) AND ACCORDING TO THE PHYSICIAN IT HAS ALWAYS BEEN PRACTICED THIS WAY. THE Z-SEAM (SUTURE) HAD NOT YET BEEN REMOVED, ACCORDING TO ANOTHER USER, THE Z-SEAM (SUTURE) WILL ONLY BE REMOVED AFTER REMOVING THE SHEATH. THEN, THE TUBE OF THE SHEATH REMAINED IN THE PATIENT AND HAD TO BE SURGICALLY REMOVED. THERE WAS PATIENT INJURY REPORTED. WHEN REMOVING THE SHEATH FROM THE PACKAGING, THE USER DID NOT NOTICE ANYTHING, THE SHEATH WAS COMPLETE AND FULLY FUNCTIONAL. WHEN THE SHEATH WAS INSERTED INTO THE PATIENT, THE PHYSICIAN FIXED THE SHEATH WITH A Z-SEAM (SUTURE). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776881 ↗
• InjuryMay 19, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, A 5F AVANTI CATHETER SHEATH INTRODUCER (AVANTI + 5F STD W/GW) WAS INSERTED IN THE RIGHT COMMON FEMORAL ARTERY THROUGH THE RIGHT GROIN USING SELDINGER TECHNIQUE. AFTER THE DIAGNOSTIC ANGIOGRAPHY, WHEN WITHDRAWING THE SHEATH, RESISTANCE WAS FELT AND THEN THE CATHETER SHEATH INTRODUCER (CSI) TORE OFF. ONE END OF THE REMAINING PART WAS STILL STUCK IN THE FEMORAL ARTERY AND THE OTHER END IN THE SUBCUTANEOUS TISSUE. BLEEDING WAS PREVENTED BY MANUAL COMPRESSION. THE BROKEN PART OF THE SHEATH WAS COMPLETELY RECOVERED IPSILATERALLY FROM THE SUBCUTANEOUS SPACE USING A MOSQUITO CLAMP, USING THE CROSS-OVER TECHNIQUE FROM THE LEFT GROIN, AFTER BALLOON OCCLUSION OF THE COMMON ILIAC ARTERY. THERE WAS NO REPORTED PATIENT INJURY. HEMOSTASIS WAS ACHIEVED USING NON-CORDIS CLOSURE DEVICES ON THE RIGHT AND ON THE LEFT. THE PATIENT WAS REPORTED TO BE A SEVENTY-EIGHT YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. RESISTANCE WAS FELT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14441416 ↗
• MalfunctionMay 4, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE BALLOON OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) RUPTURED DURING THE RETRACTION PORTION OF THE DEPLOYMENT PROCEDURE AND THE DEVICE CAME OUT OF THE BODY. THE DEVICE WAS USED WITH A 5F AVANTI + SHEATH, WHICH APPEARED TO HAVE FRAYED ON THE END OF THE SHEATH AFTER REMOVAL. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION TO THE SITE. THERE WAS NO PATIENT INJURY. NO EXCESS FORCE WAS APPLIED DURING INSERTION. THE PATIENT WAS NOT MORBIDLY OBESE. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE. THE DEVICE WAS REMOVED FROM THE PACKAGE BY THE BLACK HANDLE. THE DEVICE WAS USED IN AN INTERVENTIONAL PERIPHERAL PROCEDURE USING A RETROGRADE APPROACH. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE WAS NO VESSEL TORTUOSITY, OR PRESENCE OF PERIPHERAL VASCULAR DISEASE OR CALCIUM PRESENT AT THE PUNCTURE SITE. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED WHEN ADVANCING THE DEVICE INTO THE SHEATH. THERE WAS NO PRIOR PTA, STENT, OR VASCULAR GRAFT IN THE COMMON FEMORAL ARTERY. THE BALLOON LOST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278661 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, DURING A DIAGNOSTIC HEART CATHETERIZATION FROM THE LEFT FEMORAL APPROACH, THE DOCTOR EXPERIENCED DIFFICULTY WHEN FLUSHING THE 5F STANDARD (STD) WITH GUIDEWIRE (GW) AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI). WHILE CONTINUING TO FLUSH, THE DOCTOR NOTICED BLOOD CLOTS COMING OUT OF THE SIDE ARM OF THE SHEATH INDICATING THAT CLOTTING HAD BEEN OCCURRING IN THE SHEATH CANNULA. THE PATIENT WAS ANTICOAGULATED WITH AN INTERNATIONAL NORMALIZED RATIO (INR) OF 2 WHICH CONCERNED THE DOCTOR. HE WAS ABLE TO FINISH THE CASE WITH THE SAME SHEATH WITH NO INJURY TO THE PATIENT. THE DOCTOR WAS A VERY EXPERIENCED FEMORAL ONLY ACCESS OPERATOR WHO HAS USED CORDIS SHEATHS HIS ENTIRE CAREER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED POST PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12331059 ↗
• MalfunctionApr 8, 2021Fracture; Device Contamination with Chemical or Other Material; Fracture; Device Contamination with Chemical or Other Material

  AS REPORTED, HAIR WAS FOUND INSIDE THE STERILE PACKAGE OF THE 5F STANDARD (STD) AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) WITH GUIDEWIRE. THE MINI GUIDEWIRE LOOKS FRACTURED/SEPARATED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED, AND STORED IN THE LAB, PRIOR TO USING. THE DEVICE WAS STORED IN THE LAB AS PER THE IFU. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IMAGE IS AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633115 ↗
• 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 10140409 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, UPON INSPECTION OF THE SHEATH OF A 5F AVANTI PLUS STANDARD CATHETER SHEATH INTRODUCER (CSI) WITH MINI GUIDEWIRE (GW) WAS FOUND TO HAVE A SMALL HOLE HOWEVER, THE TIP WAS INTACT. HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. WHEN THE CSI WAS REMOVED, UPON PULLING BACK THERE WAS A BLOOD CLOT ON THE ARTERIAL SHEATH. AFTER THE CLOT WAS PULLED THROUGH WHICH NOTED TO HAVE A FAST OOZING BLOOD AT THE ACCESS SIGHT IN THE RIGHT GROIN. ON REMOVAL OF ARTERIAL SHEATH AT THE RIGHT GROIN WHICH NOTED TO HAVE A SPRAYING OF BLOOD FROM MID-SHEATH AND INSTANTLY ECCHYMOSIS WAS STARTED AT THE TARGET SITE, BUT NO FIRM HEMATOMA WAS FELT. THE SHEATH WAS TAGGED/BAGGED FOR FURTHER INSPECTION. THE PRODUCT WAS STORED AS PER LABELING. THE PRODUCT WAS OPENED IN THE STERILE FIELD. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THIS WAS ELECTROPHYSIOLOGY STUDY CASE. THE ACCESS SITE WAS THE FEMORAL VEIN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Thrombosis

  MAUDE report 9574605 ↗

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