TourGuide™ Steerable Sheath TG0855517Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850232006116), received between Jul 28, 2021 and Jun 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 16, 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.

• MalfunctionJun 10, 2024Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER STATED A 62-YEAR-OLD PATIENT TREATED FOR LEFT RENAL ARTERY RECANALIZATION. DURING THE SURGICAL PROCEDURE, THE SHEATH FOLDED IN SITU (IN THE ORIGINAL PLACE). DIFFICULTIES IN PERFORMING THE SURGICAL PROCEDURE. ITS UNCLEAR WHAT THE USER MEANT BY THE SHEATH FOLDED IN SITU. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN INFORMATION RELATED TO THIS CASE; HOWEVER, NO INFORMATION WAS PROVIDED BY CUSTOMER. PROCEDURE WAS NOT CONTINUED DUE TO UNSATISFACTORY RESULTS OF THE NEPHOGRAM SHOWING A VERY POOR-QUALITY DIFFUSION, UNRELATED TO THE FOLDING. NO ADVERSE EVENT WITH PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19500156 ↗
• MalfunctionJul 28, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE TOURGUIDE DILATOR WAS SHORTER THAN TOURGUIDE SHEATH SO IT COULDN'T BE USED. THE PATIENT RECEIVED TREATMENT, AS THE PHYSICIAN PERFORMED THE PROCEDURE WITH ANOTHER INTRODUCER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238984 ↗