VSI Micro-Introducer Kit 7246VRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M2067246V0), received between Sep 7, 2016 and Sep 7, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionSep 7, 2016Break; Component Falling

  A VSI MICRO-INTRODUCER KIT WAS USED IN A PATIENT PROCEDURE. PATIENT WAS UNDERGOING A PERIPHERAL ANGIOGRAM OF THE RIGHT LOWER EXTREMITY. THE PHYSICIAN OBTAINED LEFT FEMORAL ACCESS WITH A MICRO PUNCTURE SET WITH ULTRASOUND GUIDANCE. UPON RETRIEVAL OF THE MICRO PUNCTURE SET THE HEAD OF THE SHEATH BROKE. THE PHYSICIAN ATTEMPTED TO REMOVE THE REMAINS OF THE SHEATH FROM THE ARTERY, BUT THE SHAFT OF THE SHEATH ALSO BROKE IN HALF LEAVING THE OTHER HALF IN THE FEMORAL ARTERY. INTERVENTIONAL RADIOLOGY WAS CALLED TO ASSIST PER THE PHYSICIAN'S ORDERS. THE PHYSICIANS ATTEMPTED TO RETRIEVE REMAINS OF SHEATH FROM LEFT FEMORAL ARTERY BUT WERE UNSUCCESSFUL. THE PATIENT REMAINED IN STABLE CONDITION WITH NO COMPLAINTS. THE PHYSICIAN ORDERED A CT SCAN AFTER THE PROCEDURE. UPON REVIEWING THE CT RESULTS, THE PATIENT WAS TAKEN TO CSU FOR RECOVERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5932319 ↗