AVANTI 504607XRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705032010108), received between Mar 24, 2017 and Jun 11, 2025 — classified as 11 injuries, 9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJul 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THERE WAS TEARING OF THE 7F AVANTI CATHETER SHEATH INTRODUCER (CSI) WHEN REMOVING IT AT THE END OF THE PROCEDURE. THERE WAS EXTRACTION OF THE DISTAL PIECE SUBCUTANEOUSLY. THIS CAUSED EXTENSION OF THE DURATION OF THE PROCEDURE AND THE DOSES OF RADIATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287013 ↗
• InjuryApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER "SEVERAL USINGS" A 7F AVANTI+ CATHETER SHEATH INTRODUCER SEPARATED INTO 2 PIECES INSIDE THE PATIENT, AND A LONG TIME WAS SPENT TRYING TO REMOVE THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT IS UNAVAILABLE AT THIS TIME. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796895 ↗
• InjuryJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AT THE END OF A GENERAL ANESTHESIA (GA) ATRIAL FIBRILLATION (AF) ABLATION, THE ELECTROPHYSIOLOGY (EP) FELLOW WENT TO REMOVE A 7F 11CM AVANTI PLUS STANDARD CATHETER SHEATH INTRODUCER (CSI) WITH GUIDEWIRE, NO OBTURATOR. THE FELLOW WAS REMOVING THE 7F AVANTI CSI ALONG WITH TWO 8F AVANTI PLUS 11CM CSI¿S, ALL FROM THE RIGHT FEMORAL VEIN, WHEN THE 7F AVANTI CSI BROKE, LEAVING 8CM OF THE SHAFT WITHIN THE PATIENT¿S VEIN WHICH WAS CONFIRMED VIA X-RAY. A VASCULAR SURGEON WAS THEN CALLED TO REVIEW IF A SURGICAL CUT-DOWN WOULD BE REQUIRED; HOWEVER, IT WAS DECIDED TO OBTAIN AN ADDITIONAL VASCULAR ACCESS UNDER THE EXISTING PUNCTURE SITE WITH AN UNKNOWN 7F CSI. THIS WAS FOLLOWED BY THE USE OF A NON-CORDIS SNARING DEVICE TO SNARE THE SEPARATED PORTION OF THE 7F AVANTI CSI AND REMOVE IT PERCUTANEOUSLY WITHOUT NEED FOR A VASCULAR CUT DOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102679 ↗
• MalfunctionJan 15, 2021Difficult to Remove; Difficult to Remove

  DURING AN ABLATION SURGERY, ONCE THE PROCEDURE WAS FINISHED, THE PHYSICIAN HAD RESISTANCE WHEN REMOVING THE SHEATH. THE SHEATH HAD A LONG CUT WITH THE 7F STANDARD (STD) WITH GUIDEWIRE (W/GW) NO OBTURATOR (OBT) AVANTI PLUS CATHETER SHEATH INTRODUCER WHEN THE INTERVENTION WAS OVER.WHEN THEY COULD REMOVE IT, WITHOUT COMPLICATION FOR THE PATIENT, THE SHEATH HAD A CUT. THE PHYSICIAN BELIEVES THE INTRODUCER MAY NOT BE COMPATIBLE WITH THE NON -CORDIS DEVICE GRID CATHETER. THE AVANTI PLUS ALSO PRESENTS A LONGITUDINAL CUT. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN USED AN HD GRIP THAT MIGHT HAVE LED TO THE DAMAGE OF THE AVANTI PLUS. THE TYPE OF PROCEDURE WAS AN ABLATION. THE ACCESS SITE WAS FEMORAL. THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE VESSEL CHARACTERISTICS AT TARGET SITE WAS CALCIFIED AND TORTUOUS. THE DEVICE WAS NOT BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THE DIFFICULTY WAS WHEN, ONCE THE PROCEDURE WAS FINISHED, THEY WANTED TO REMOVE THE SHEATH AND IT SHOWED RESISTANCE. OTHER PRODUCTS WERE SUCCESSFULLY USED WITH THE DEVICE PRIOR TO THE ENCOUNTERED RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11176646 ↗
• MalfunctionDec 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 7F STANDARD (STD) AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) WITH GUIDEWIRE (GW) NO OBTURATOR (OBT) BROKE AT THE END OF AN INTERVENTION (A FEMORAL VEIN ABLATION). ONE PART OF THE INTRODUCER REMAINED INSIDE THE PATIENT. SURGERY WAS NEEDED AND PATIENT IS DOING WELL NOW. THE ZONE IN WHICH THEY WERE WORKING HAD MORE FAT AND THEY TRIED TO PULL OUT FROM A DIFFERENT PART OF THE INTRODUCER INSTEAD FROM THE UPPER SIDE. THE ACCESS SITE WAS THE FEMORAL. THE LESION WAS MODERATELY CALCIFIED. THERE VESSEL TORTUOSITY WAS LITTLE TO MODERATE. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. UNUSUAL FORCE WAS USED ONLY TO REMOVE THE INTRODUCER WHEN THE PROCEDURE FINISHED. AT THAT MOMENT IT BROKE. THERE WERE NO OTHER ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. ONE PART OF THE INTRODUCER (NO MORE THAN 5 CM) IS AVAILABL

  Patient problems: Foreign Body In Patient

  MAUDE report 10968478 ↗
• InjuryNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHILE THE PHYSICIAN WAS PULLING OUT A 7F STANDARD (STD) WITH GUIDEWIRE (W/GW) NO OBTURATOR (OBT) AVANTI PLUS CATHETER SHEATH INTRODUCER; THE SHEATH BROKE. THEY HAD TO SNARE THE PART OF THE SHEATH THAT WAS LEFT IN THE PATIENT WHICH WAS DETACHED WHEN THE SHEATH WAS PULLED OUT. THE USER WAS TRAINED WITH THE DEVICE. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10904896 ↗
• 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 ¿INSIGHT¿ THE STERILE PACKAGE OF A 7F 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. 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 10140730 ↗
• 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 10140692 ↗
• 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 10140685 ↗
• 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 10140637 ↗
• 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 10140586 ↗
• MalfunctionSep 13, 2019Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  TWO 7F AVANTI + 7F STD W/GW NO OBT CATHETER SHEATH INTRODUCERS (CSI) WERE OPENED AND AN OILY SUBSTANCE AROUND THE HUB AREA WAS NOTICED. ONE OF THE DEVICES WAS USED IN A CASE WHEN THEY NOTICED THE OILY SUBSTANCE. THERE WERE EIGHT ADDITIONAL UNITS WITH THE SAME LOT NUMBER THAT WERE PULLED FOR PRECAUTION BUT NOT CONFIRMED TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO OTHER ANOMALIES NOTED TO THE DEVICE UPON OPENING. THE PACKAGES WERE COMPLETELY SEALED. IT SEEMS AS THOUGH THEY ALL ARE SOMEWHAT OILY. IT IS NOT VISIBLE BUT TO THE TOUCH IT FEELS IT. ONE OF THE TWO OPENED DEVICES WAS DISCARDED, AND THE OTHER DEVICE IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9032050 ↗
• InjuryAug 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE SI AVANTI+ 7F STD W/GW NO OBT SHEATH HAS COME DISCONNECTED FROM THE VALVE. THE SHEATH WENT INTO THE PATIENT AND HAD TO BE REMOVED BY A VASCULAR SURGEON. THE DEVICE WILL NOT BE RETURNED BY THE HOSPITAL. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915715 ↗
• InjuryAug 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE SI AVANTI+ 7F STD W/GW NO OBT SHEATH HAS COME DISCONNECTED FROM THE VALVE. THE SHEATH WENT INTO THE PATIENT AND HAD TO BE REMOVED BY A VASCULAR SURGEON. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915323 ↗
• MalfunctionAug 9, 2019Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  TWO 7F AVANTI + 7F STD W/GW NO OBT CATHETER SHEATH INTRODUCERS (CSI) WERE OPENED AND AN OILY SUBSTANCE AROUND THE HUB AREA WAS NOTICED. ONE OF THE DEVICES WAS USED IN A CASE WHEN THEY NOTICED THE OILY SUBSTANCE. THERE WERE EIGHT ADDITIONAL UNITS WITH THE SAME LOT NUMBER THAT WERE PULLED FOR PRECAUTION BUT NOT CONFIRMED TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO OTHER ANOMALIES NOTED TO THE DEVICE UPON OPENING. THE PACKAGES WERE COMPLETELY SEALED. IT SEEMS AS THOUGH THEY ALL ARE SOMEWHAT OILY. IT IS NOT VISIBLE BUT TO THE TOUCH IT FEELS IT. ONE OF THE TWO OPENED DEVICES WAS DISCARDED, AND THE OTHER DEVICE IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881492 ↗
• InjuryMar 28, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, RESISTANCE WAS ENCOUNTERED WHILE TRYING TO REMOVE AN SI AVANTI+ SHEATH (7F STD W/GW NO OBT) FOLLOWING A PROCEDURE. A SINGLE STITCH HAD BEEN APPLIED AND THE GUIDING CATHETER HAD BEEN REMOVED. AN UNKNOWN AMOUNT OF FORCE WAS USED TO REMOVE THE SHEATH CAUSING THE SHEATH TO BREAK. AN APPROXIMATELY 4CM SECTION OF THE INTRODUCER WAS LEFT IN THE PATIENT. THE PATIENT WAS THEN SENT TO VASCULAR SURGERY OPERATING ROOM WHERE A SECOND PROCEDURE WAS REQUIRED TO REMOVE THE SEPARATED SECTION OF SHEATH FROM THE PATIENT. THIS EVENT CAUSED THE PATIENT TO STAY IN THE HOSPITAL LONGER THAN EXPECTED. THE PATIENT WAS REPORTED TO BE FEELING WELL FOLLOWING THIS EVENT. THE DEVICE WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THE PROCEDURE BEING PERFORMED WAS A PULMONARY VEIN ABLATION. THE PROCEDURE HAPPENED ON (B)(6). THE SHEATH HAD NOT KINKED OR BEEN TWISTED/TORQUED PRIOR TO THE SEPARATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8462681 ↗
• InjuryMar 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 7F SI AVANTI+ STD W/GW NO OBT SHEATH SHEARED OFF FROM THE HUB AND BECAME LODGED UNDER THE SKIN, THE PUNCTURE SITE HAD TO BE EXTENDED TO REMOVE THE SHEATH WITH FORCEPS. THIS WAS A CARDIAC ABLATION PROCEDURE FOR ATRIAL FLUTTER VIA THE RIGHT FEMORAL VENOUS APPROACH. THREE SHEATHS WERE INSERTED, A 9F, 7F AND 6F. ACCESS WAS DIFFICULT AND PROLONGED, BUT EVENTUALLY SUCCESSFUL. THE FIRST TWO SHEATHS (9F AND 6F) WERE REMOVED. BLEEDING AND CONTROL OF THE ENTRY SITE WAS SUCCESSFUL. THE WOUND WAS SUTURED CLOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8448282 ↗
• InjuryMar 24, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE 7FR AVANTI SHEATH TIP BROKE OFF (SEPARATED) WHILE ATTEMPTING TO PULL THE SHEATH IN THE PATIENT. INTERVENTIONAL RADIOLOGY & FLUOROSCOPY ON THE SHEATH WAS PERFORMED, THE SHEATH TIP WAS LOCATED AND SNARED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6431404 ↗

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