GLIDESHEATH 15-1060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701009933), received between Feb 7, 2017 and May 14, 2025 — classified as 1 injury, 2 malfunctions.

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

• InjuryMay 14, 2025Fracture; Unraveled Material; Fracture; Unraveled Material

  THE USER FACILITY REPORTED THAT THE NEEDLE WAS INSERTED, BUT THE WIRE WOULD NOT TRACK, ALTHOUGH IT WAS SUSPECTED THAT THE NEEDLE WAS INSIDE THE VESSEL. THEREFORE, THE WIRE WAS PULLED OUT. AT THIS POINT, IT WAS NOTICED THAT THE WIRE WAS UNRAVELING. THE WIRE WAS SAVED, ALTHOUGH IT APPEARS THE NEEDLE WAS THROWN AWAY. THE PROCEDURE FOR THE PATIENT WAS A LEFT HEART CATHETERIZATION. THE PATIENT'S CONDITION IS STABLE, WITH NO BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVELY. NO CONCOMITANT MEDICAL PRODUCTS WERE USED WITH THE INVOLVED DEVICE. PENDING RESULTS OF A COMPUTED TOMOGRAPHY (CT) SCAN TO DETERMINE IF SUBSEQUENT ACTION IS NEEDED OR IF ALL COMPONENTS WERE REMOVED. ADDITIONAL INFORMATION WAS RECEIVED ON 17 APRIL 2025: THE CT SCAN SHOWS THE FILAMENT IS IN THE BODY. IT IS LISTED AS NON-OCCLUSIVE AND APPEARS TO NOT BE IN THE ARTERY. THE PATIENT WANTS IT REMOVED, SO SCHEDULING FOR REMOVAL IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023001 ↗
• MalfunctionNov 12, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER FACILITY REPORTED THAT THEY ORDERED 15-1060 HOWEVER, THE ACTUAL PRODUCT INSIDE OF THE BOX WAS 35-1060 AND WAS LABELED AS SUCH. THE EVENT OCCURRED PRE-TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10829888 ↗
• MalfunctionFeb 7, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING USE, IT WAS NOTED THAT THE VALVE WAS LEAKING MORE THAN NORMAL; THE SHEATH WAS REMOVED AND REPLACED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND IT WAS REPORTED THAT THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6308613 ↗