TourGuide™ Steerable Sheath TG0654509Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850232006017), received between Feb 13, 2023 and Dec 9, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE THERE WAS A LEAK AT THE STOPCOCK. THE PRODUCT IS STILL AT THE HOSPITAL, IF NEEDED IT CAN BE RETURNED OTHERWISE IT WILL BE DESTROYED. THE PATIENT RECEIVED TREATMENT ON (B)(6) 2024. PATIENT STATUS AT TIME OF THIS REPORT ALIVE - NO INJURY. THE ISSUE WAS RESOLVED BY USING ANOTHER TOURGUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20886453 ↗
• MalfunctionMar 9, 2023Mechanical Problem; Mechanical Problem

  CUSTOMER SAYS THAT THE DILATOR DOES NOT CLICK INTO THE GUIDE AND TENDS TO SLIDE AWAY FROM THE GUIDE IF PRESSURE IS PUT ON THE DILATOR TIP. THE PATIENT HAS NOT RECEIVED TREATMENT. THERE IS NO KNOWN PATIENT HARM REPORTED. THE ISSUE HAS NOT BEEN RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513835 ↗
• MalfunctionFeb 13, 2023Mechanical Problem; Mechanical Problem

  THIS DEVICE WAS USED IN AN ILIAC RECANALIZATION PROCEDURE, EVENT OCCURRED AT THE TIME OF THE PUNCTURE. THE DEVICE WAS INSERTED INTO THE PATIENT, WHILE THE REPRESENTATIVE WAS HOLDING THE DILATOR TIGHT WITH HER FINGERS. SHE REPORTED EXCESSIVE FORCE WAS USED. PER THE END USER THE DILATOR DOES NOT ATTACHED TO THE GUIDE AND THIS CAUSES THE DEVICE TO MALFUNCTION. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES, BUT WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368512 ↗
• MalfunctionFeb 13, 2023Mechanical Problem; Mechanical Problem

  THE HANDLE IS OUTSIDE OF THE PATIENT AND THE COMPLAINT IS ABOUT THE DILATOR-TO-GUIDE CONNECTION OUTSIDE OF THE PATIENT'S BODY. THE DILATOR DOES NOT CONNECT TO THE GUIDE. THERE IS NOTHING THAT IT CAN STAY CONNECTED TO. THE DILATOR IS COMPLETELY LOOSE AND FREE-RIDING AND IMMEDIATELY UPON TOUCHING ANYTHING AT THE END IT WILL SLIDE INSIDE OF THE GUIDE. THE PATIENT HAS NOT AND WILL NOT RECEIVE TREATMENT. EVENT WAS NOT RESOLVED. IT IS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368229 ↗
• MalfunctionFeb 13, 2023Mechanical Problem; Mechanical Problem

  THE HANDLE IS OUTSIDE OF THE PATIENT AND THE COMPLAINT IS ABOUT THE DILATOR-TO-GUIDE CONNECTION OUTSIDE OF THE PATIENT'S BODY. THE DILATOR DOES NOT CONNECT TO THE GUIDE. THERE IS NOTHING THAT IT CAN STAY CONNECTED TO. THE DILATOR IS COMPLETELY LOOSE AND FREE-RIDING AND IMMEDIATELY UPON TOUCHING ANYTHING AT THE END IT WILL SLIDE INSIDE OF THE GUIDE. THE PATIENT HAS NOT AND WILL NOT RECEIVE TREATMENT. EVENT WAS NOT RESOLVED. IT IS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368218 ↗