AVANTI 402607XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032000673), received between Nov 14, 2024 and Dec 9, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING THE CORONARY ABLATION PROCEDURE, THE 7F .035-INCH AVANTI+ SHEATH INTRODUCER BROKE WHILE BEING WITHDRAWN. WHEN THE SHEATH BROKE ONLY PART OF THE SHEATH WAS WITHDRAWN. THE OPERATOR REPORTED THAT HE DID NOT FEEL ANY ABNORMAL RESISTANCE DURING THE WITHDRAWAL OF THE SHEATH AND DID NOT USE A LOT OF FORCE WHEN WITHDRAWING THE SHEATH. THE SURGEON PRESSED ON THE DISTAL PORTION OF THE VESSEL AS SOON AS HE REALIZED THAT THE SHEATH HAD BROKEN AND REMOVED THE ENTIRE BROKEN SHEATH WITH FORCEPS; HENCE, THE SHEATH FRACTURE SITE APPEARS AS A FLATTENED LACERATION. INITIALLY, A SHORT 7F AVANTI+ SHEATH WAS PLACED THROUGH FEMORAL VEIN PUNCTURE, AND THE GUIDEWIRE AND 7F CORONARY SINUS ELECTRODE WERE DELIVERED AFTER SUCCESSFUL PUNCTURE. THE SHEATH INSERTION WAS SMOOTH DURING THE PUNCTURE AND DELIVERY OF THE INSTRUMENTS, WITH NO SIGNIFICANT RESISTANCE. LATER, DUE TO THE NEEDS OF THE PROCEDURE, THE SHEATH WAS INTENDED TO BE REPLACED WITH A LARGER ONE. THEREFORE, ALL INSTRUMENTS WERE WITHDRAWN, AND AN EXCHANGE GUIDEWIRE WAS PLACED WITH THE INTENTION OF WITHDRAWING THE 7F SHEATH. THAT IS WHEN THE SHEATH BROKE. A CONTRALATERAL APPROACH WAS USED. THE ACCESS SITE VESSEL CHARACTERISTICS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887580 ↗
• InjuryNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, UPON REMOVAL FROM THE PATIENT, THE 7F 11 CM AVANTI PLUS SHEATH INTRODUCER WITH MINI-GUIDEWIRE WAS NOTED BROKEN. ONE PART OF THE CATHETER STAYED IN THE PATIENT'S RIGHT HAND AND THE TIP STAYED IN THE PATIENT. THE PHYSICIAN WAS SUCCESSFUL IN REMOVING THE DISTAL PART FROM THE PATIENT. THE 7F SHEATH WAS BEING USED FOR AN ATRIAL FIBRILLATION ABLATION PROCEDURE FOR A QUADRIPOLAR NON-CORDIS LEAD FOR FEMORAL VENOUS ACCESS. A PICTURE WAS RECEIVED FOR REVIEW. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684657 ↗

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