AVANTI 402606XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032000628), received between Apr 12, 2021 and Feb 17, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Delivered as Unsterile Product

  AS REPORTED, THE 6F AVANTI+ SHEATH INTRODUCER LOOKS TO HAVE BEEN TRAPPED WHILE IN PRODUCTION. THE CASE WAS COMPLETED USING ANOTHER SHEATH FROM THE SAME BOX. THERE WAS NO REPORTED INJURY TO THE PATIENT.THE PRODUCT WAS NOT PREPPED AS IT WAS NOT USED. THE PRODUCT WAS STORED ACCORDING TO THE SITE¿S STANDARD PROCEDURES. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364152 ↗
• MalfunctionJun 3, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF A 6F .035 AVANTI + SHEATH INTRODUCER WAS FOUND TO BE SPLIT AFTER REMOVAL. THERE WERE DIFFICULTIES ENCOUNTERED WHILE REMOVING DEVICES THROUGH THE SHEATH. THERE WERE NO REPORTS OF PATIENT INJURY. THE PATIENT DEVELOPED THROMBOSIS IN THE ARTERIOVENOUS FISTULA OF THE LEFT UPPER LIMB AND REQUIRED THROMBECTOMY, SELECTIVE ARTERIAL ANGIOGRAPHY, AND BALLOON ANGIOPLASTY FOR THE ARTERIOVENOUS FISTULA FOR RENAL DIALYSIS. DURING THE PROCEDURE, UNDER THE GUIDANCE OF COLOR DOPPLER ULTRASOUND, THE DISTAL RADIAL ARTERY WAS PUNCTURED SUCCESSFULLY, AND AN AVANTI + SHEATH WAS INSERTED AFTER SUCCESSFUL PUNCTURE. FOLLOWING BALLOON ANGIOPLASTY TREATMENT, IT WAS FOUND DIFFICULT TO WITHDRAW THE BALLOON. ANGIOGRAPHY SHOWED NORMAL BALLOON CONTRACTION. DESPITE REPEATED ATTEMPTS BY THE OPERATOR TO REMOVE THE BALLOON, IT WAS DIFFICULT TO DO SO. THE SURGEON THEN REMOVED THE SHEATH AND BALLOON TOGETHER WITH THE GUIDEWIRE. THIS IS WHEN THE SPLIT WAS OBSERVED ON THE TIP OF THE SHEATH. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447446 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A 6F MYNX CONTROL VASCULAR CLOSURE DEVICE WAS INSERTED INTO A CORDIS AVANTI 6F CATHETER SHEATH INTRODUCER (CSI). THE BALLOON WAS INFLATED UNTIL THE BLACK MARKER WAS FULLY VISIBLE, WHITE BLACK WHITE. AFTER POSITIONING OF THE BALLOON ACCORDING TO TENSION INDICATOR AND UNDER FLUOROSCOPY, THE PLUG WAS RELEASED BY PUSHING BUTTON NUMBER ONE. IT WAS NOTICED THAT THE BLACK MARKER FOR THE PRESSURE GAUGE WAS NO LONGER VISIBLE. AFTER REMOVAL OF THE DEVICE AND ONE MINUTE FINGERTIP COMPRESSION, HEMOSTASIS WAS NOT ACHIEVED, AND MANUAL COMPRESSION WAS NEEDED TO CLOSE. THE PLUG WAS NOT VISIBLE ON THE DEVICE. APPROXIMATELY THIRTY MINUTES AFTER THE PROCEDURE, THE PATIENT CAME BACK DUE TO PAIN IN THE LEG. IT IS UNKNOWN WHERE IN THE LEG THE PAIN WAS BEING EXPERIENCED. A CROSSOVER ANGIOGRAM WAS PERFORMED AFTER THE PAIN WAS REPORTED BUT THE RESULTS WERE NOT PROVIDED. THE PATIENT IS STILL HOSPITALIZED AND UNDER OBSERVATION AS OF SIX DAYS AFTER THE EVENT. THE REASON FOR THE PAIN IS STILL UNKNOWN. THE USER IS IN TRAINING ON THE USE OF THE DEVICE AND THIS WAS THE SECOND CASE PERFORMED, WITH THE SALES REPRESENTATIVE PRESENT. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919225 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, 3 DAYS AFTER USING THE 6F .035 AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) WITH MINI GUIDEWIRE (GW), THE PATIENT¿S LEFT THIGH BECAME NUMB, NO HEMATOMA, NO PAIN, AND NO OBVIOUS RELIEF. AFTER A WEEK, THE VENOUS THROMBOSIS OF LOWER EXTREMITY WAS EXAMINED, AND HYPOECHOIC FILLING WAS FOUND IN THE LEFT GREAT SAPHENOUS VEIN LUMEN. THE PATIENT WAS TREATED WITH THROMBOLYTIC THERAPY AND RECOVERED. THERE WAS A PATIENT INJURY NOTED. THE INTENDED PROCEDURE WAS A RIGHT FEMORAL VEIN RADIO FREQUENCY (RF) ABLATION WITH FEMORAL VEIN ACCESS. THERE WAS NO CALCIFICATION, NO TORTUOSITY, NO STENOSIS, NO ACUTE ANGLE, AND NO BIFURCATION. THE SHEATH WAS NOT KINKED/BENT UPON REMOVAL. THE SHEATH WAS USED ONLY FOR THE PROCEDURE AND WAS NOT KEPT INTRAVENOUSLY FOR FURTHER TREATMENT AFTER THE PROCEDURE. THE SHEATH WAS IN PLACE FOR 2 HOURS. THE PATIENT WAS RETURNED TO THE LAB 7 DAYS AFTER THE PROCEDURE FOR VENOGRAPHY. ANTICOAGULANTS (HEPARIN) WERE USED. THE PATIENT DID NOT HAVE A PREVIOUS DIAGNOSIS OF ANY HYPERCOAGULATION DISORDER OR HISTORY OF DVT/THROMBOSIS. THERE WERE NO MULTIPLE SHEATH EXCHANGES. THE HYPOECHOIC FILLING WAS CONFIRMED TO BE A CLOT BY "B SCAN". OTHER PROCEDURAL DETAILS WERE REQUESTE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11647578 ↗

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