VSI IPN916043Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156107031), received between Mar 8, 2023 and Mar 8, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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.

• MalfunctionMar 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: "WIRES SEPARATED. QTY OF 2." ASSOCIATED TO ANOTHER COMPLAINT. ADDITIONAL INFORMATION ON 22FEB2023: THE COMPLAINT WAS ON TWO WIRES OF THE SAME LOT NUMBER OF THE MICROPUNCTURE KITS. THERE WERE NO ADVERSE EFFECTS TO PATIENT MENTIONED IN PHONE CALL. SEVERAL ATTEMPTS TO GAIN MORE INFORMATION FROM THE ACCOUNT HAVE BEEN UNSUCCESSFUL. A FOLLOW UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16501832 ↗
• MalfunctionMar 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: "WIRES SEPARATED. QTY OF 2." ASSOCIATED TO ANOTHER COMPLAINT. ADDITIONAL INFORMATION ON (B)(6) 2023: THE COMPLAINT WAS ON TWO WIRES OF THE SAME LOT NUMBER OF THE MICROPUNCTURE KITS. THERE WERE NO ADVERSE EFFECTS TO PATIENT MENTIONED IN PHONE CALL. SEVERAL ATTEMPTS TO GAIN MORE INFORMATION FROM THE ACCOUNT HAVE BEEN UNSUCCESSFUL. A FOLLOW UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16501812 ↗