AVANTI 504604XRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705032009935), received between Sep 16, 2019 and Feb 8, 2021 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A 4F STANDARD WITH GUIDEWIRE AVANTI PLUS SHEATH INTRODUCER TORE THE ARTERY DURING ITS INTRODUCTION. THE PATIENT SUFFERED ARTERIAL RUPTURE. SUTURE OF THE INJURED ARTERY WAS DONE. A NEW UNKNOWN DEVICE WAS USED TO CONTINUE THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Vascular Dissection

  MAUDE report 11298198 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 4F AVANTI PLUS STANDARD (STD) WITH GUIDEWIRE (GW) CATHETER SHEATH INTRODUCER (CSI) TORE THE ARTERY DURING ITS INTRODUCTION. THEREFORE, THE ARTERY HAD TO BE SUTURED AND A NEW UNKNOWN DEVICE WAS USED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Vascular Dissection

  MAUDE report 11289902 ↗
• MalfunctionSep 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THE CUSTOMER NOTED FIVE AVANTI SHEATHS (TWO 4F, TWO 6F, AND ONE 8F) WHERE FLUID (LIKE WATER) CAN BE SEEN INSIDE THE STERILE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THREE PRODUCTS WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED.

  Patient problems: No Patient Involvement

  MAUDE report 9071591 ↗
• MalfunctionSep 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THE CUSTOMER NOTED FIVE AVANTI SHEATHS (TWO 4F, TWO 6F, AND ONE 8F) WHERE FLUID (LIKE WATER) CAN BE SEEN INSIDE THE STERILE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THREE PRODUCTS WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED.

  Patient problems: No Patient Involvement

  MAUDE report 9071590 ↗
• MalfunctionSep 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THE CUSTOMER NOTED FIVE AVANTI SHEATHS (TWO 4F, TWO 6F, AND ONE 8F) WHERE FLUID (LIKE WATER) CAN BE SEEN INSIDE THE STERILE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THREE PRODUCTS WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED.

  Patient problems: No Patient Involvement

  MAUDE report 9071586 ↗
• MalfunctionSep 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THE CUSTOMER NOTED FIVE AVANTI SHEATHS (TWO 4F, TWO 6F, AND ONE 8F) WHERE FLUID (LIKE WATER) CAN BE SEEN INSIDE THE STERILE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THREE PRODUCTS WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED.

  Patient problems: No Patient Involvement

  MAUDE report 9071585 ↗
• InjurySep 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THE CUSTOMER NOTED FIVE AVANTI SHEATHS (TWO 4F, TWO 6F, AND ONE 8F) WHERE FLUID (LIKE WATER) CAN BE SEEN INSIDE THE STERILE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THREE PRODUCTS WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED.

  Patient problems: No Patient Involvement

  MAUDE report 9071579 ↗

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