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TightRail™ 545-513AARecalls & reported problems

Spectranetics Corporation · TightRail™ Rotating Dilator Sheath · Class 2

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M204545513AA0), received between Jun 19, 2018 and Jun 19, 2018 — classified as 1 death.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Death1
  • Iatrogenic Source1
  • Perforation of Vessels1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    Patient problems: Death; Iatrogenic Source; Perforation of Vessels

    MAUDE report 7617642 ↗

Other Dilator, Vessel, For Percutaneous Catheterization devices

All Dilator, Vessel, For Percutaneous Catheterization devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.