GLIDESHEATH SLENDER TIBIAL PEDAL KIT 51-1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701011912), received between Jul 12, 2019 and Apr 11, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryApr 11, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS TRYING TO ACCESS A HEAVILY CALCIFIED POSTERIOR TIBIAL ARTERY IN A CRITICAL LIMB ISCHEMIA (CLI) PATIENT. NEEDLE ACCESS WAS ACHIEVED IN THE VESSEL HOWEVER, WHILE ATTEMPTING TO ADVANCE THE WIRE FROM THE KIT THROUGH THE NEEDLE INTO VESSEL, THE WIRE GOT STUCK IN THE CALCIUM BURDEN OF THE VESSEL. WHEN TRYING TO PULL THE WIRE BACK, THE TIP OF THE WIRE BROKE OFF AND WAS LEFT IN THE PATIENT. NO COMPLICATIONS WERE FOR THE PATIENT BECAUSE THE WIRE TIP WAS SECURED IN THE CALCIUM BURDEN OF THE OCCLUDED VESSEL. THE PROCEDURE FOR PATIENT WAS LEG ANGIOGRAM FOR CRITICAL LIMB ISCHEMIA (CLI). THERE WAS NO BLOOD LOSS. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 14MAR2024: THERE ARE NO PLANS TO REMOVE BECAUSE THE DOCTOR CONSIDERED IT NON-SIGNIFICANT AND THAT IT WAS NOT NEGATIVELY IMPACTING THE PATIENT. APPROXIMATELY 1CM OF THE WIRE TIP WAS LEFT IN THE PATIENT. PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19092971 ↗
• MalfunctionJul 6, 2022Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE GUIDEWIRE IN THE GLIDESHEATH SLENDER KIT GOT STUCK INSIDE OF THE PROVIDED NEEDLE AND REQUIRES MANIPULATION TO SUCCESSFULLY PASS THROUGH THE NEEDLE. PATIENT CONDITION WAS STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 21 JUN 2022: THE PROCEDURE FOR THE PATIENT WAS A PERIPHERAL ANGIOGRAM WITH ANGIOPLASTY AND ATHERECTOMY OF RIGHT LOWER EXTREMITY. THEY DID NOT SWITCH TO A NEW GLIDESHEATH SLENDER (GSS) TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14926166 ↗
• MalfunctionJul 12, 2019Unintended Movement; Unintended Movement

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER SHEATH PROLAPSED INTO ITSELF WHEN ATTEMPTING TO REMOVE A 0.018 BARD BALLOON, FULLY DEFLATED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 8, 2019: THE PROCEDURE WAS A ANGIOGRAM AND INTERVENTION OF SUPERFICIAL FEMORAL ARTERY (SFA).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8784994 ↗