AVANTIRecalls & reported problems across all models

We found 11 models of AVANTI by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2017 and Sep 11, 2026 — classified as 27 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (30 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AVANTI problems

AVANTI models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AVANTI 504607X

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  20 reports
• AVANTI 504605X

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  16 reports
• AVANTI 504611X

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  14 reports
• AVANTI 504604X

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  7 reports
• AVANTI 504605S

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  3 reports
• AVANTI 504609X

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  3 reports
• AVANTI 402611X

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  2 reports
• AVANTI 504657A

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  2 reports
• AVANTI 402610X

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 report
• AVANTI 504604S

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 report
• AVANTI 504606A

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 report

Recent AVANTI adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionApr 20, 2026Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, A 9F 11CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) BROKE OFF WHILE INSIDE OF THE PATIENT. THERE WAS DIFFICULTY REMOVING THE SHEATH PRIOR TO OBSERVING THE SEPARATION, AND IT WAS REMOVED BY PULLING IT OUT MANUALLY. THE SEPARATED SEGMENT WAS SUBSEQUENTLY REMOVED FROM THE PATIENT BY THE PHYSICIAN, WHO RETRIEVED IT MANUALLY WITH HIS HANDS. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926894 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  AS REPORTED, DURING PREPARATION THE LUER HUB OF THE VESSEL DILATOR FOR A 5F 7.5CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) BROKE OFF IN THE SHEATH WHEN REMOVING THE DILATOR. A NEW 5F 7.5CM AVANTI PLUS CSI WAS USED AS A REPLACEMENT. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND WAS STORED IN THE PROCEDURE ROOM PRIOR TO THE PROCEDURE. THE FACILITY DOES NOT USE ROOM STERILIZATION METHODS INVOLVING ULTRAVIOLET (UV) LIGHT OR OZONE. THERE WAS NO VISIBLE DAMAGE TO THE PACKAGE PRIOR TO USE, NO DIFFICULTY INSERTING THE DILATOR INTO THE SHEATH, AND THE LUER HUB OF THE DILATOR DID NOT KINK OR BEND DURING INSERTION. THE DILATOR WAS SNAPPED INTO PLACE AT THE HUB PRIOR TO INSERTION OF THE SHEATH, AND THERE WAS NO DIFFICULTY WITHDRAWING THE DILATOR FROM THE SHEATH PRIOR TO THE SEPARATION OCCURRING. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777213 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  AS REPORTED, DURING PREPARATION THE PROXIMAL END OF THE VESSEL DILATOR FOR A 5F 7.5CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) BROKE OFF IN THE SHEATH WHEN REMOVING THE DILATOR. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND IT WAS KEPT IN THE PROCEDURE ROOM PRIOR TO THE PROCEDURE. THE FACILITY DOES NOT USE STERILIZATION METHODS INVOLVING ULTRAVIOLET LIGHT OR O-ZONE. THERE WAS NO VISIBLE DAMAGE TO THE PACKAGING BEFORE USE. NO DIFFICULTY WAS ENCOUNTERED WHEN INSERTING THE DILATOR INTO THE SHEATH, AND THE LUER HUB DID NOT KINK OR BEND DURING INSERTION. THE DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777127 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  AS REPORTED, THE PROXIMAL END OF THE VESSEL DILATOR FOR A 5F 7.5CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) BROKE OFF IN THE SHEATH WHEN REMOVING THE DILATOR. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND WAS KEPT IN THE PROCEDURE ROOM PRIOR TO THE PROCEDURE. THE FACILITY DOES NOT USE ROOM STERILIZATION METHODS INVOLVING ULTRAVIOLET LIGHT OR O ZONE. THERE WAS NO VISIBLE DAMAGE TO THE PACKAGING PRIOR TO USE. THERE WAS NO DIFFICULTY INSERTING THE DILATOR INTO THE SHEATH, THE LUER HUB DID NOT KINK OR BEND DURING INSERTION, AND THE DILATOR WAS SNAPPED INTO PLACE AT THE HUB PRIOR TO INSERTION OF THE SHEATH. THE ACCESS VESSEL WAS THE RIGHT FEMORAL VEIN, WHICH WAS NOT CALCIFIED OR TORTUOUS AND HAD NO OTHER NOTED CHARACTERISTICS. NO DIFFICULTY WAS EXPERIENCED DURING INSERTION OF THE SHEATH AND DILATOR INTO THE PATIENT, AND THERE WAS NO DIFFICULTY WITHDRAWING THE DILATOR FROM THE SHEATH PRIOR TO THE SEPARATION OCCURRING. THE DEVICE WILL BE RETURNED FOR EVALUATION ALONG WITH 27 STERILE UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777075 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HEMOSTASIS VALVE OF AN 11F 11CM AVANTI+ CATHETER SHEATH INTRODUCER (CSI) SEPARATED FROM THE CATHETER AND WAS NOTED ON THE CORONARY SINUS CATHETER AFTER REMOVAL AND THERE WAS NO WAY TO PREVENT BACK BLEEDING AND SUBSTANTIAL BLOOD LOSS OTHER THAN QUICKLY REMOVING THE REST OF THE CATHETER PREMATURELY FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THIS FAILURE OCCURRED WHEN REMOVING CORONARY SINUS CATHETERS AT THE CONCLUSION OF THE CASE. THE CATHETER WAS PREPPED CORRECTLY BY THE OR STAFF. THE PROCEDURE WAS ALREADY COMPLETE WHEN THIS EVENT OCCURRED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709074 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HEMOSTASIS VALVE OF AN 11F 11CM AVANTI+ CATHETER SHEATH INTRODUCER (CSI) SEPARATED FROM THE CATHETER AND WAS NOTED ON THE CORONARY SINUS CATHETER AFTER REMOVAL AND THERE WAS NO WAY TO PREVENT BACK BLEEDING AND SUBSTANTIAL BLOOD LOSS OTHER THAN QUICKLY REMOVING THE REST OF THE CATHETER FROM THE PATIENT PREMATURELY. THERE WAS NO REPORTED PATIENT INJURY. THIS FAILURE OCCURRED WHEN REMOVING CORONARY SINUS CATHETERS AT THE CONCLUSION OF THE CASE. THE CATHETER WAS PREPPED CORRECTLY BY THE OR STAFF. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709016 ↗
• MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, TWO PARTS OF AN 11F 11CM AVANTI+ CATHETER SHEATH INTRODUCER (CSI) SEPARATED FROM EACH OTHER AND THE CSI REPORTEDLY FAILED PART WAY THROUGH ROBOTIC CARDIAC SURGERY PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. PACKAGING AND LOT NUMBERS WERE NOT AVAILABLE FOR RETRIEVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697501 ↗
• InjuryAug 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755553 ↗
• InjuryJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 7F AVANTI+ SHEATH (THIRD SHEATH) HAD SIGNIFICANT RESISTANCE WHEN ATTEMPTED TO BE REMOVED. ON CLOSER INSPECTION, IT APPEARED TO HAVE SPLIT ROUGHLY 1 CM DOWN FROM THE VALVE. BLOOD WAS COMING OUT THE SPLIT. AT THE SPLIT, A SMALL PORTION OF THE PLASTIC WAS STICKING OUT WHICH WAS CATCHING ON THE SKIN (HOOK LIKE EFFECT) AND PREVENTED THE PHYSICIAN FROM REMOVING THE SHEATH. THE PHYSICIAN ADVANCED THE SHEATH A FEW TIMES WHILE ATTEMPTING THE TURN THE SHEATH HOPING TO ¿UNHOOK¿ THIS PORTION OF THE SHEATH. THIS WAS UNSUCCESSFUL. THE PHYSICIAN THEN PULLED A LITTLE HARDER IN THE HOPES THAT THE HOOK WOULD BEND AND ALLOW THE SHEATH TO BE REMOVED. THE SHEATH UNFORTUNATELY BROKE IN HALF. IT WAS SUBSEQUENTLY SUCCESSFULLY SNARED FROM THE NECK. THE CASE WAS UNEVENTFUL TILL THIS POINT. TWO OF THE THREE SHEATHS CAME OUT EASILY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183007 ↗
• InjuryNov 27, 2024Difficult to Remove; Stretched; Unraveled Material; Detachment of Device or Device Component; Difficult to Remove; Stretched; Unraveled Material; Detachment of Device or Device Component

  AS REPORTED, A 7F 11CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) WAS INSERTED INTO THE FEMORAL VEIN TO PERFORM AN ATRIAL FIBRILLATION (AF) ABLATION. THE CSI WAS PREPARED AND DE-AIRED AS PER INSTRUCTIONS FOR USE (IFU) USING HEPARINIZED SALINE, AND IT WAS INSERTED USING ULTRASOUND GUIDANCE BY AN EXPERIENCED OPERATOR. THERE WAS NO RESISTANCE DURING INSERTION. UPON SUCCESSFUL COMPLETION OF THE AF ABLATION THE 7F 11CM AVANTI PLUS CSI WAS REMOVED. INITIALLY, THERE WAS NO RESISTANCE WHILE REMOVING THE SHEATH, BUT A SMALL AMOUNT OF RESISTANCE WAS NOTED TOWARDS THE END OF THE REMOVAL AND THE USERS NOTICED THE SHEATH HAD STRETCHED AND THE DISTAL END OF THE SHEATH HAD SPLIT. A PORTION OF THE DISTAL TIP WAS RETAINED IN THE PATIENT WHICH WAS CONFIRMED VIA COMPUTED TOMOGRAPHY (CT). A SURGICAL CUTDOWN TO RETRIEVE THE TIP WAS PERFORMED THE SAME DAY AFTER CONFIRMING THE SHEATH¿S TIP POSITION ON CT, BUT IT WAS UNSUCCESSFUL. NO EVIDENCE OF THE SEPARATED PORTION OF THE SHEATH WAS FOUND. FOLLOWING THE UNSUCCESSFUL CUTDOWN PROCEDURE, THE PATIENT WAS TRANSFERRED TO A TERTIARY CENTER FOR REMOVAL, WHERE THE TIP, WHICH HAD MIGRATED TO THE PULMONARY VEIN, WAS REMOVED USING AN UNKNOWN SNARE DURING A SEPARA

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 20796273 ↗
• 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 ↗

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