TWIN-PASS IPN913543Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10841156100353), received between Aug 13, 2020 and Oct 6, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "STENTED LAD, LOST SIDE BRANCH- ATTEMPTED TO WIRE SIDE BRANCH WITH TWIN PASS. WIRED SIDE BRANCH SUCCESSFULLY, REMOVED TWIN PASS, THEN NOTICED 11MM OF THE TIP WAS BROKEN OFF, WIRED DISTAL LAD BALLOON PULLED LOOSE TIP BACK INTO GUIDE, RE-SHEATHED AND REMOVED SUCCESSFULLY. NO CHANGES TO VITALS THROUGHOUT. THERE WAS NO REPORTED PATIENT HARM OR HEALTH CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221088 ↗
• InjuryMay 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE TWIN PASS WAS USED FOR MEDICATION ADMINISTRATION PREPPED AND FLUSHED WITH NO ISSUES. THE MARKER TIP SHEARED WHERE THE WIRE COMES OUT. IT WAS SEPARATED IN TWO PIECES. THE TWIN PASS WAS NOT REMOVED IN ITS ENTIRETY- THE PIECE BROKE OFF IN THE DISTAL TIP OF THE VESSEL AND WE WERE UNABLE TO RETRIEVE IT THERE WAS NO RESOLUTION. THE REMAINING PART OF THE TWIN PASS WAS REMOVED AND THE SHEARED PIECE REMAINED IN THE VESSEL."

  Patient problems: Foreign Body In Patient

  MAUDE report 22042476 ↗
• MalfunctionSep 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: TIP BROKE OFF AT END OF CASE WHEN PULLING IT OUT OF THE HEMOSTASIS DEVICE. ADDITIONAL INFORMATION: THE PROCEDURE WAS A PCI. THE CATHETER WAS PREPPED AND FLUSHED WITHOUT ANY ISSUE. THE PATIENT IS REPORTED AS FINE POST THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: Insufficient Information

  MAUDE report 17698668 ↗
• InjuryFeb 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: TIP OF TWINPASS BROKE OFF UNNOTICED AND WAS DISPLACED INTO CORONARY VESSEL. IT WAS RETRIEVED WITH BALLOON TRAPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501417 ↗
• MalfunctionJan 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: THE TIP BROKE OFF. MULTIPLE REQUESTS HAVE BEEN SENT FOR FURTHER INFORMATION. NO RESPONSE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13373744 ↗
• MalfunctionOct 4, 2021Break; Break

  AS REPORTED: TIP OF THE TWINPASS SHEARED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573645 ↗
• InjuryAug 13, 2020Separation Problem; Separation Problem

  AS REPORTED: TWIN-PASS TIP BROKE OFF IN PATIENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10401200 ↗