TourGuide™ Steerable Sheath TG0655509Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00850232006031), received between Jan 20, 2023 and Sep 7, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THE DILATOR DOES NOT "CLICK' SHUT INTO THE TOURGUIDE. THUS, IT DOES NOT STAY IN PLACE WHILE ADVANCING INTO THE PATIENT. THE EVENT OCCURRED DURING THE PROCEDURE AND THE PATIENT RECEIVED TREATMENT. THE CUSTOMER STATED THE ISSUE HAS NOT RESOLVED. THE HEALTHCARE PROFESSIONAL STATED THE CAUSE OF THE EVENT WAS ERROR OF GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699702 ↗
• MalfunctionMar 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE EVENT OCCURRED DURING PRE-OP, THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE LEAKED FROM THE VALVE, AT THE BEGINNING OF THE HOSE ON THE SIDE WHERE THE TAP IS LOCATED AND AT THE TURNING MECHANISM. THE ISSUE WAS RESOLVED USING A NEW PRODUCT. THE PATIENT DID NOT RECEIVE TREATMENT. THE DEVICE IS EXPECTED TO BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600008 ↗
• MalfunctionMar 8, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED DURING A PROCEDURE FOR SMA STENTING, THE SIDEARM OF THIS 6.5F TOUR GUIDE SHEATH FELL OFF AND STARTED LEAKING BLOOD (APPROXIMATELY 100MLS). NO BLOOD TRANSFUSION WAS REQUIRED. IN ORDER TO CONTROL THE BLOOD LOSS, THE PHYSICIAN PLACED FINGER OVER HOLE IN SHEATH, WHILE AN EXCHANGE FOR A NEW 6.5F TOURGUIDE SHEATH (SAME MODEL) WAS COMPLETED. THE PROCEDURE WAS DELAYED FOR 10 MINUTES, TO FIND AND EXCHANGE A NEW SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CAUSE OF THE EVENT IS UNKNOWN. THERE WERE NO REPORTED PATIENT SYMPTOMS, OR COMPLICATIONS ASSOCIATED WITH THIS EVENT (ALIVE, NO INJURY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503372 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  HEMOSTATIC VALVE FELL OUT AND BLOOD LEAKED ONTO THE TABLE. USED NEW DEVICE TO FINISH PROCEDURE AS NORMAL. THE PATIENT RECEIVED TREATMENT. NO INJURY TO PATIENT. ADDITIONAL PATIENT INFORMATION RECEIVED: PATIENT RECEIVED COELIAC ARTERY ANEURYSM STENT GRAFTING. BLOOD LOST REPORTED AS 100MLS - ISH. 5F STANDARD SHEATH INTRODUCED THROUGH THE END OF THE DEVICE (WHERE THE HEMOSTATIC VALVE WAS) TO STOP THE BLEEDING AND ALLOW A SUPPORTIVE WIRE TO BE INTRODUCED TO FACILITATE EXCHANGE. SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 10 MINS DELAY FINDING A NEW SHEATH - PUT IN SUPPORTING GUIDEWIRE AND EXCHANGE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488615 ↗
• MalfunctionFeb 14, 2023Mechanical Problem; Mechanical Problem

  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. THE HANDLE IS OUTSIDE OF THE PATIENT AND THE COMPLAINT IS ABOUT THE DILATOR-TO-GUIDE CONNECTION OUTSIDE OF THE PATIENT´S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375486 ↗
• MalfunctionJan 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIANS WERE USING A 6.5F TOURGUIDE IN A LEAD INTERVENTIONAL RADIOLOGY (IR) CASE AND REPORTED THE SHEATH WAS LEAKING AT THE BACKEND WIRE PORT. ANOTHER 6.5F TOURGUIDE FROM SAME LOT NUMBER, WAS OPENED AND THE GREEN CAP FELL OFF. PATIENT RECEIVED TREATMENT. REPORTED EVENT WAS RESOLVED AS CASE WAS COMPLETED. IT WAS REPORTED NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. REFERENCE REPORT # 1035166-2023-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225639 ↗
• MalfunctionJan 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE PHYSICIANS WERE USING A 6.5F TOURGUIDE IN A LEAD INTERVENTIONAL RADIOLOGY (IR) CASE AND REPORTED THE SHEATH WAS LEAKING AT THE BACKEND WIRE PORT. ANOTHER 6.5F TOURGUIDE FROM SAME LOT NUMBER, WAS OPENED AND THE GREEN CAP FELL OFF. PATIENT RECEIVED TREATMENT. REPORTED EVENT WAS RESOLVED AS CASE WAS COMPLETED. IT WAS REPORTED NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. REFERENCE REPORT#: 1035166-2023-00007.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225559 ↗
• MalfunctionJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING PROCEDURE THE SIDE ARM FELL OFF AND NEW DEVICE WAS REQUIRED. THE PATIENT RECEIVED TREATMENT. PROCEDURE CONTINUED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16219111 ↗