AVANTI 402605XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032000574), received between May 22, 2017 and Feb 3, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, WHILE PERFORMING AN ARTERIAL PUNCTURE ON THE PATIENT DURING INTERVENTIONAL THERAPY, A TEAR ON THE DISTAL TIP OF THE 5F .035-INCH AVANTI + CATHETER SHEATH INTRODUCER WAS NOTED. NO DIFFICULTIES WERE ENCOUNTERED WHILE INSERTING THE DILATOR, HOWEVER, DIFFICULTIES WERE ENCOUNTERED WHILE REMOVING THE DILATOR. THE ARTERIAL SHEATH WAS PROMPTLY REPLACED AND THE PROCEDURE PROCEEDED NORMALLY. THERE WERE NO REPORTS OF PATIENT INJURY. THE HOSPITAL REPORTED THIS CASE AS AN ADVERSE EVENT TO 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 PRIOR TO OPENING. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE ACCESS SITE VESSEL WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS NOT SNAPPED INTO PLACE AT THE HUB. NO DIFFICULTIES WERE ENCOUNTERED DURING THE INSERTION PROCESS. NO DIFFICULTIES WERE ENCOUNTERED DURING THE WITHDRAWAL PROCESS. THE DEVICE DID NOT KINK IN THE AFFECTED AREA. NO DIFFICULTIES WERE ENCOUNTERED WHILE REMOVING DEVICES THROUGH THE SHEATH. NO EXCESS FORCE WAS USED DURING THE USE OF THE DEVICE. THE DAMAGE OCCU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297842 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, AFTER USE OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) AND A 5F AVANTI+ INTRODUCER SHEATH THE PATIENT DEVELOPED A BACTERIAL INFECTION IN THE PUNCTURE SITE. THE ENTIRE HOSPITALIZATION WAS SIX DAYS. HEMOSTASIS WAS ACHIEVED WITH THE MYNX DEVICE. THE DEVICE DEPLOYED AS EXPECTED. THE DEVICE PACKAGING WAS NOT COMPROMISED DURING STORAGE. THE PACKAGING WAS OPENED IN A STERILE FIELD AND STERILE TECHNIQUE WAS FOLLOWED. THE PUNCTURE SITE WAS STERILIZED PRIOR TO THE PROCEDURE WITH A STERILE ANTISEPTIC SOLUTION. THE PATIENT STAYED IN THE HOSPITAL FOR FIVE DAYS AFTER THE INFECTION WAS FOUND. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE 5F CORDIS VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE WAS MILD VESSEL TORTUOSITY. THERE WAS NO PRESENCE OF CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS PRIOR TO THE PROCEDURE. THE PATIENT WAS UNDER LOCAL ANESTHESIA DURING THE PROCEDURE. THE PROCEDURE WAS PERFORMED AS INPATIENT. THE ACCESS SITE WAS CLEANED/MAINTAINED POST-PROCEDURE WITH A BANDAGE WITH

  Patient problems: Post Operative Wound Infection

  MAUDE report 18571396 ↗
• InjuryMay 22, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE AVANTI SHEATH TIP SEPARATED IN THE PATIENT DURING REMOVAL. PHYSICIAN EXPLAINED THE EVENT THAT OCCURRED TO THE PATIENT AND THE EXTRACTION PROCESS. THE RADIOLOGIST SURGEONS AND ANESTHESIOLOGIST WERE NOTIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6581173 ↗

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