TightRail Guardian 575-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813132027438), received between Mar 9, 2023 and Mar 31, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO REDUNDANCY. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL, BUT WAS NOT INITIALLY TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. THE PHYSICIAN CHOSE A SPECTRANETICS 11F TIGHTRAIL GUARDIAN MOTORIZED DILATOR SHEATH TO BEGIN THE PROCEDURE. ADVANCEMENT WAS MADE TO THE CLAVICLE, THEN PROGRESS STALLED. THE RA LEAD, WHICH WAS NOT PREPPED FOR LEAD EXTRACTION, WAS COILED IN FRONT OF THE ACTIVELY DILATING TIGHTRAIL GUARDIAN, WHICH RESULTED IN THE RA LEAD BEING CUT. FURTHER PROGRESS STALLED, SO THE PHYSICIAN USED FEMORAL SNARING TECHNIQUES TO GRAB THE RV LEAD TO FINISH THE EXTRACTION. HOWEVER, DUE TO LEAD ON LEAD BINDING, THE RA LEAD WAS ALMOST PULLED OUT ALONG WITH THE RV LEAD. BOTH LEADS WERE SUCCESSFULLY REMOVED; RE-IMPLANTATION OF NEW RA AND RV LEADS WAS COMPLETED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 11F TIGHTRAIL GUARDIAN WHICH CUT THE RA LEAD, REQUIRING RE-IMPLANTATION OF A NEW RA LEAD. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659200 ↗
• MalfunctionMar 9, 2023Sharp Edges; Sharp Edges

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS. THE PHYSICIAN CHOSE A SPECTRANETICS 11F TIGHTRAIL GUARDIAN MOTORIZED DILATOR SHEATH TO TREAT THE PATIENT. DURING REMOVAL OF THE 2ND LEAD, THE TIGHTRAIL GUARDIAN DISPLAYED AN UNRECOVERABLE ERROR STATE (URE) AND COULD NO LONGER BE USED. A 2ND TIGHTRAIL GUARDIAN WAS OPENED, AND THE CASE WAS COMPLETED WITH NO REPORTED PATIENT HARM. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE BLADES OF THE TIGHTRAIL GUARDIAN WERE IN AN EXTENDED POSITION PAST THE DISTAL TIP, RESULTING IN SHARP EDGES. THIS REPORT CAPTURES THE 11F TIGHTRAIL GUARDIAN WITH BLADES EXTENDED, SHARP EDGES, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518694 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS NO LONGER REPORTABLE FOR THE TIGHTRAIL GUARDIAN DEVICE CAUSING OR CONTRIBUTING TO AN ADVERSE EVENT REQUIRING INTERVENTION. AFTER FURTHER REVIEW AND PHYSICIAN ASSESSMENT, IT WAS DETERMINED THAT SNARING IS A STANDARD ADJUNCTIVE TECHNIQUE IN LEAD EXTRACTION PROCEDURES, NOT CONSIDERED ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518079 ↗