AVANTI 504609XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032010191), received between May 6, 2019 and Apr 20, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, A 9F 11CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) BROKE OFF WHILE INSIDE OF THE PATIENT. THERE WAS DIFFICULTY REMOVING THE SHEATH PRIOR TO OBSERVING THE SEPARATION, AND IT WAS REMOVED BY PULLING IT OUT MANUALLY. THE SEPARATED SEGMENT WAS SUBSEQUENTLY REMOVED FROM THE PATIENT BY THE PHYSICIAN, WHO RETRIEVED IT MANUALLY WITH HIS HANDS. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926894 ↗
• InjuryFeb 9, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, THERE WAS AN ABNORMAL FOLDING OF A 9F STANDARD WITH GUIDEWIRE NO OBTURATOR AVANTI PLUS SHEATH INTRODUCER WHICH MADE STRENGTHENING AND REMOVAL OF THE DEVICE EXTREMELY DIFFICULT. THE CSI HAD A "SORT OF KINK". THE REMOVAL OF THE SHEATH INTRODUCER REQUIRED THE USE OF AN UNKNOWN WIRE AND AN UNKNOWN 5F DILATOR WITHOUT COMPLICATIONS. THE PROCEDURE WAS EXTENDED FOR THE UNSPECIFIED TIME NECESSARY TO WITHDRAW THE DEVICE AND THE PROCEDURE WAS THEN POSTPONED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THE DEVICE WAS USED FOR AN ELECTROPHYSIOLOGY PROCEDURE, NOT FOR VESSEL LESIONS NOR CTO, USING FEMORAL ACCESS. THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO DIFFICULTY FLUSHING THE SHEATH. THERE WAS NOTHING NOTED TO BE BLOCKING THE SHEATH. THERE WAS NO EXCESS FORCE APPLIED DURING INSERTION. THE INSERTION DIFFICULTY WAS NOT CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXIST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300649 ↗
• MalfunctionMay 6, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A SI AVANTI PLUS (STD W/GW NO OBT) HAD AN OILY SUBSTANCE AROUND THE RING SO ANOTHER DEVICE WAS RETRIEVED TO USE FOR THE PROCEDURE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THIS PRODUCT WAS NEVER USED ON A PATIENT. UPON OPENING THE PACKAGE, THE SUBSTANCE WAS NOTICED AND NOT PUT TO USE. NO PACKAGING WAS DAMAGED OR ALTERED BEFORE NOTICING THE SUBSTANCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8581953 ↗

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