AVANTI 504656XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032010382), received between Sep 28, 2023 and Oct 17, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier.

1 other recall 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 31, 2015Terminated

   Incorrect cannula of the sheath introducer (smaller than intended).

   Z-1174-2016 · Root cause: Mixed-up of materials/components · FDA record ↗

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.

• MalfunctionOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL TIP OF A .038 AVANTI+ CARDIOLOGY MS CATHETER SHEATH INTRODUCER (CSI) SHEARED WHILE BE REMOVED FROM THE PATIENT AFTER A CARDIAC ABLATION PROCEDURE WAS COMPLETED. THE FRACTURED PIECE MIGRATED TO THE RIGHT ATRIUM. ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE SHEARED PIECE. THE FRACTURED PIECE WAS REMOVED USING ULTRASOUND GUIDANCE, BEGINNING WITH A 21-GAUGE MICRO-PUNCTURE NEEDLE TO ACCESS THE RIGHT INTERNAL JUGULAR VEIN, FOLLOWED BY ADVANCING A MICRO-PUNCTURE WIRE INTO THE SUPERIOR VENA CAVA. A MICRO-PUNCTURE TRANSITION SET AND AN UNKNOWN 8F SHORT-SHEATH WERE THEN PLACED. ONCE THE FRACTURED PORTION WAS IDENTIFIED IN THE RIGHT ATRIUM, A RIGHT GROIN ACCESS SHEATH WAS UTILIZED TO ADVANCE A WIRE, REMOVE THE ORIGINAL SHEATH, AND PLACE AN UNKNOWN 12F SHEATH. AN ENSNARE DEVICE WAS USED THROUGH THIS SHEATH TO GRASP AND REMOVE THE FRACTURED COMPONENT COMPLETELY. A CONTRALATERAL APPROACH WAS ALSO USED, PLACING THREE UNKNOWN 6F SHEATHS IN THE RIGHT FEMORAL VEIN WITHOUT DIFFICULTY, AIDED BY INTRAVASCULAR ULTRASOUND. A NON-CORDIS CATHETER WAS PLACED IN THE CORONARY SINUS, AND AN 8F NON-CORDIS SHEATH WAS ADVANCED INTO THE RIGHT ATRIUM. USING A NON-CORDIS SHEATH INTRODUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474690 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WAS USED WITH 6F CORDIS AVANTI CATHETER SHEATH INTRODUCER (CSI) AND THE PATIENT DEVELOPED A PSEUDOANEURYSM. A THROMBIN INJECTION WAS REQUIRED. THERE WAS NO OTHER REPORTED PATIENT INJURY. THE PROCEDURE WAS A DIAGNOSTIC HEART CATHETERIZATION. THERE WAS NO ANTICOAGULATION. THE USER IS TRAINED TO THE USE OF THE MYNX DEVICE. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE WAS NO VESSEL TORTUOSITY AND NO PRESENCE OF PVD / CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THE TARGET FEMORAL SITE HAD NOT BEEN PREVIOUSLY CLOSED WITH ANY CLOSURE PRIOR TO THIS PROCEDURE. THERE WERE NO MULTIPLE SHEATH EXCHANGES. A SINGLE STICK WAS USED FOR ACCESS. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Pseudoaneurysm

  MAUDE report 17834230 ↗

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.