AVANTI 504657ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032010399), received between Jun 10, 2021 and Jun 10, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.

• MalfunctionJun 10, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED, THE BOX LABEL AND INSIDE KIT LABEL OF TWO (2) 7F .038 AVANTI PLUS MS CATHETER SHEATH INTRODUCER (CSI) DO NOT HAVE THE LETTERS MS PRINTED ON PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THE 7F AVANTI MS WAS RECEIVED WITH CORRECT PRODUCT CODE ON BOX AND ON INSIDE KITS. THE DEVICES WERE STORED AS PER LABELING. THE DEVICES WERE NOT USED IN PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION. PHOTOGRAPH WERE PROVIDED AND AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975036 ↗
• MalfunctionJun 10, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED, THE BOX LABEL AND INSIDE KIT LABEL OF TWO (2) 7F .038 AVANTI PLUS MS CATHETER SHEATH INTRODUCER (CSI) DO NOT HAVE THE LETTERS MS PRINTED ON PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THE 7F AVANTI MS WAS RECEIVED WITH CORRECT PRODUCT CODE ON BOX AND ON INSIDE KITS. THE DEVICES WERE STORED AS PER LABELING. THE DEVICES WERE NOT USED IN PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION. PHOTOGRAPH WERE PROVIDED AND AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975026 ↗

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