AVANTI 402604XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032000529), received between Jan 4, 2024 and Jan 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2024Fracture; Fracture

  AS REPORTED, THE ACCOUNT STATED THAT THE INTRODUCER WIRE OF TWO 4F AVANTI SHEATH INTRODUCER (SI) WITH MINI GUIDEWIRE (GW) COULD NOT GO THROUGH THE HEMOSTATIC VALVE FROM EITHER SIDE. THE INTRODUCER WIRE COULD GO THROUGH THE DISTAL END OF THE SHEATH. THE PROBLEM WAS NOTICED AT THE BEGINNING AND LATER ON WHILE USING THE SECOND DEVICE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICES WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE SECOND DEVICE WAS COMPLETED AND THE DISTAL END OF THE GUIDEWIRE WAS INSPECTED USING A VISION SYSTEM CONFIRMING AN UNRAVEL CONDITION. ALSO, A SEPARATED CONDITION ON THE CORE WIRE WAS OBSERVED ON THE SECOND DEVICE. THE CORE WIRE IS SEPARATED IN TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445935 ↗

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