AVANTI 504505XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032009836), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 malfunction.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  AS REPORTED, AFTER INSERTION INTO THE PATIENT A 5F .038¿ VESSEL DILATOR HAD TO BE REMOVED AS THERE WAS AN INCOMPLETE CONNECTION AT THE VALVE. THERE WAS NO REPORTED PATIENT INJURY. RESISTANCE WAS FELT PROXIMAL AT THE SIDE ARM/VALVE WHEN THREADING THE WIRE. AFTER INSERTION INTO THE PATIENT, A ¿PARALUMINATE¿ (WATER LEAKED OUT NEXT TO THE LOCK CONNECTION PART). THERE WAS SIMPLY A VALVE LEAK. THE INTENDED PROCEDURE WAS REPORTED TO BE A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR WHICH A CONTRALATERAL APPROACH WAS NOT USED. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE VESSEL DILATOR SNAPPED INTO PLACE AT THE HUB. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING THE INSERTION PROCESS OR DURING THE WITHDRAWAL PROCESS. THERE WAS NO EXCESS FORCE USED DURING THE PROCEDURE. ONLY WHEN THE WIRE WAS THREADED THROUGH DID A RESISTANCE BECOME APPARENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537882 ↗

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