VSI IPN916036Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156107109), received between Aug 20, 2022 and Jul 14, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT: THE PHYSICIAN WAS PUTTING WIRE IN THROUGH THE NEEDLE AND HAD DIFFICULTY. WHEN HE TRIED TO PULL THE WIRE OUT HE HAD DIFFICULTY AND THEN WIRE WAS SHREDDED. ADDITIONAL INFORMATION: DURING A PERIPHERAL ANGIOPLASTY PROCEDURE, WHILE GAINING ACCESS IN A HEAVILY CALCIFIED FEMORAL ARTERY, THE TIP OF THE GUIDEWIRE UNRAVELLED AND SEPARATED. THE GUIDEWIRE WAS REMOVED IN ITS ENTIRETY. ANOTHER MIK WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT HARM, INJURY OR HEALTH CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323426 ↗
• MalfunctionAug 20, 2022Material Frayed; Material Frayed

  DISTAL COIL OF MIK WIRE UNRAVELED. ADDITIONAL INFORMATION ON 17AUG2022: THE ACCOUNT REPORTED NOTHING WAS LEFT IN THE PATIENT, AND THE PATIENT IS FINE. AFTER MULTIPLE GOOD FAITH ATTEMPTS, THE ACCOUNT WOULD NOT RELEASE ANY ADDITIONAL INFORMATION OR RESPOND TO THE REQUESTED QUESTIONS.

  Patient problems: Insufficient Information

  MAUDE report 15263248 ↗