AVANTI 402608ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032000680), received between Nov 5, 2019 and Nov 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TEN 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW) AND ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW) CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE ELEVEN DEVICES WERE RETURNED FOR EVALUATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280399 ↗

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