VSI Micro-Introducer Kit 7272XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M2067272X0), received between Jul 3, 2018 and Jul 3, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 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.

• InjuryJul 3, 2018Detachment Of Device Component; Detachment Of Device Component

  THE BLUE INNER DILATOR BENT, AND TODAY THEY GOT THE WIRE STUCK AND THEN IT BROKE OFF INSIDE THE PATIENT. PHYSICIAN DID RETRIEVE THE WIRE. PER PHYSICIAN THE WIRE LOOPED IN THE GRAFT, BECAUSE OF THE LOOP/KINK THE WIRE WOULDN'T PULL OUT. HE PUSHED FORWARD AND THEN PULLED BACK HARD AND IT FRACTURED. HE SNARED WITH A SNARE DEVICE. IT FRACTURED IN THE STIFF PART OF THE WIRE. IT WAS STUCK IN A CLOTTED GRAFT AND SAID HE PULLED PRETTY HARD AND HAD NO PROBLEM IF HE HAD TO SNARE IT. NO HARM OR DELAY IN TREATMENT TO THE PATIENT. THE CASE WAS FINISHED. ADDITIONAL INFORMATION REC'D 05JUN18: HE WAS A DECLOT PATIENT, IN OPERATING ROOM. WE USED THE MICRO THEN USED THE BLUE DILATOR AND WIRE IN PRE-ACCESSED SITE TO PUT IN 7FR SHEATH. THEN GOT A 2ND ACCESS USING THE ACCESS KIT. NEEDLE WIRE, BLUE DILATOR AND WHITE DILATOR. THEN SWITCHED TO ANOTHER 7FR SHEATH. THE WIRE GOT STUCK, AND THE BLUE DILATOR BENT. THE TIP OF THE BLUE BROKE OFF, AND THE WIRE BROKE OFF, BOTH INSIDE OF THE PATIENT. PHYSICIAN THEN SUCCESSFULLY SNARED THE WIRE, WHICH HAD THE TIP OF THE BROKEN BLUE DILATOR ON IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7659262 ↗