AVANTI 504658XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032010443), received between Aug 6, 2020 and Jul 21, 2021 — classified as 2 injuries.

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.

• InjuryJul 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF AN 8.5F .038¿ AVANTI PLUS CARDIOLOGY MID-SIZE (MS) GOT SHEARED OFF WHILE PULLING IT AT THE END OF AN ATRIAL FIBRILLATION (A-FIB) PROCEDURE. THE TIP WAS EVENTUALLY REMOVED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12205487 ↗
• InjuryAug 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING WITHDRAWAL OF AN 8F .038 AVANTI PLUS CATHETER SHEATH INTRODUCER DURING AN ELECTROPHYSIOLOGY (EPO) TREATMENT PROCEDURE, THE CANNULA SEPARATED FROM THE SHEATH AND REMAINED INSIDE THE PATIENT¿S GROIN. AN ADDITIONAL SURGERY WAS REQUIRED AND THE SURGEON OPENED THE GROIN AND THE FEMORAL VEIN, RETRIEVING THE BROKEN PART. THE PATIENT REMAINED HOSPITALIZED FOR TWO ADDITIONAL NIGHTS. THE PATIENT¿S STATUS WAS GOOD, HE/SHE LEFT THE HOSPITAL AND WENT HOME. THE REMAINDER OF THE PRODUCT WILL BE RETURNED FOR ANALYSIS. A PHOTOGRAPH OF THE SEPARATED DEVICE WITHOUT THE CANNULA WAS PROVIDED. THE PROCEDURE WAS PERFORMED VIA A RIGHT FEMORAL ACCESS. THERE WAS NO CALCIFICATION OBSERVED AT THE ACCESS SITE AND IT WAS CONFIRMED BY THE VASCULAR SURGEON WHO EXPLORED/OPENED THE FEMORAL VEIN FOR RETRACTION OF THE SEPARATED CANNULA OF THE SHEATH. THERE WERE NO ABNORMALITIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THERE WAS NO DIFFICULTY OR RESISTANCE DURING PREP, INSERTION OF DILATOR, INSERTION OVER THE WIRE, REMOVAL OF DILATOR AND INSERTION OR WITHDRAWAL OF ANY OTHER DEVICES THROUGH THE SHEATH. THERE WAS ALSO NO RESISTANCE DURING WITHDRAWAL OF ANY OF THE DEVICES THROUGH THE SHEATH. THERE WAS

  Patient problems: Foreign Body In Patient

  MAUDE report 10373282 ↗

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