AVANTI 402611XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032000789), received between Apr 5, 2021 and Apr 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 18, 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.

• MalfunctionApr 5, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  UPON RECEIPT, TWO (2) F11 0.035 11CM AVANTI PLUS TRANSRADIAL KIT CATHETER SHEATH INTRODUCER (CSI) WITH MINI GUIDEWIRE HAD UNKNOWN LIQUIDS NEAR THE SIX-PAGE FLAP OF THE INNER SHEATH OF THE SHORT SHEATH IN INNER PACKING. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGED NOTED TO THE DEVICE PACKAGES. THE DEVICES ARE EXPECTED TO BE RETURNED FOR ANALYSIS. IMAGE IS AVAILABLE FOR REVIEW. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615986 ↗
• MalfunctionApr 5, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  UPON RECEIPT, TWO (2) F11 0.035 11CM AVANTI PLUS TRANSRADIAL KIT CATHETER SHEATH INTRODUCER (CSI) WITH MINI GUIDEWIRE HAD UNKNOWN LIQUIDS NEAR THE SIX-PAGE FLAP OF THE INNER SHEATH OF THE SHORT SHEATH IN INNER PACKING. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGED NOTED TO THE DEVICE PACKAGES. THE DEVICES ARE EXPECTED TO BE RETURNED FOR ANALYSIS. IMAGE IS AVAILABLE FOR REVIEW. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615935 ↗

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