TWIN-PASS IPN916104Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156107390), received between Mar 28, 2023 and Oct 16, 2024 — classified as 1 injury, 1 malfunction.

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

• InjuryOct 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "AFTER THE PCI PROCEDURE IN PATIENT'S CALCIFIED, MODERATELY TORTUOUS RCA, USER REMOVED THE TWIN-PASS CATHETER FROM THE PATIENT AND OBSERVED THE DISTAL TIP OF THE CATHETER RAPID EXCHANGE LUMEN IS DAMPENED. USER CONCERNED SOME PARTS OF THE TIP DISLODGED AND REMAINED IN THE VESSEL AND THUS PERFORMED ANOTHER STENTING TO COVER THE SITE. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: Foreign Body In Patient

  MAUDE report 20461603 ↗
• MalfunctionMar 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT: TIP WAS SHEARED WHILE GOING THROUGH A STENT STRUT. IT STAYED ON THE WIRE AND WAS REMOVED FROM THE PATIENT. PATIENT WAS REPORTED AS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625956 ↗