GLIDEWIRE GS3543Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350726704), received between May 23, 2025 and May 23, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 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.

• InjuryMay 23, 2025Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE DOCTOR HAD A 450CM STIFF ANGLED GLIDEWIRE GOING FROM THE LEFT RADIAL ARTERY TO THE RIGHT PERONEAL ARTERY AND PROCEEDED TO INTRODUCE A 3MMX100MM METACROSS R2P BALLOON INTO THE POPLITEAL ARTERY WHERE HE BEGAN INFLATING TO NOMINAL PRESSURES ALL ALONG THE POPLITEAL AND SUPERFICIAL FEMORAL ARTERIES WITH GOOD SUCCESS. THE BALLOON WAS THEN BROUGHT BACK THROUGH THE DESTINATION SLENDER 119CM SHEATH AND EXITED TO SHEATH WITHOUT ISSUE. ONCE THE BALLOON WAS OUT OF THE SHEATH ABOUT 20CM IT STOPPED TRACKING ON THE STIFF GLIDEWIRE. THE DOCTOR TRIED PULLING HARD WITH HANDS, THEN WITH CLAMPS AND FINALLY TO RELEASE IT WITH A KNIFE TO NO AVAIL, THE BALLOON WAS STUCK ON THE WIRE. HE HAD TO TAKE THE WIRE OUT OF THE BODY AND GET A NEW WIRE. THE PROCEDURE WAS A RADIAL TO RIGHT LEG PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ADDITIONAL INFORMATION WAS RECEIVED FROM (B)(4) REGARDING THE INVESTIGATION OF THEIR DEVICE AND THE REPORTED GUIDEWIRE ON 25APR2025: THE CATHETER WAS RETURNED WITH THE GUIDEWIRE (GW) STUCK INSIDE. MULTIPLE SECTIONS OF THE GUIDEWIRE (GW) SHOWED PEELED COATING, SHAFT DEFORMATION, AND FRACTURES. THE INNER SHAFT WAS FOUND ADHERED TO THE GUIDEWIRE (GW)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077962 ↗
• InjuryMay 23, 2025Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE DOCTOR HAD A 450CM STIFF ANGLED GLIDEWIRE GOING FROM THE LEFT RADIAL ARTERY TO THE RIGHT PERONEAL ARTERY AND PROCEEDED TO INTRODUCE A 3MMX100MM METACROSS R2P BALLOON INTO THE POPLITEAL ARTERY WHERE HE BEGAN INFLATING TO NOMINAL PRESSURES ALL ALONG THE POPLITEAL AND SUPERFICIAL FEMORAL ARTERIES WITH GOOD SUCCESS. THE BALLOON WAS THEN BROUGHT BACK THROUGH THE DESTINATION SLENDER 119CM SHEATH AND EXITED TO SHEATH WITHOUT ISSUE. ONCE THE BALLOON WAS OUT OF THE SHEATH ABOUT 20CM IT STOPPED TRACKING ON THE STIFF GLIDEWIRE. THE DOCTOR TRIED PULLING HARD WITH HANDS, THEN WITH CLAMPS AND FINALLY TO RELEASE IT WITH A KNIFE TO NO AVAIL, THE BALLOON WAS STUCK ON THE WIRE. HE HAD TO TAKE THE WIRE OUT OF THE BODY AND GET A NEW WIRE. THE PROCEDURE WAS A RADIAL TO RIGHT LEG PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ADDITIONAL INFORMATION WAS RECEIVED FROM KANEKA REGARDING THE INVESTIGATION OF THEIR DEVICE AND THE REPORTED GLIDEWIRE ON 25APR2025: THE CATHETER WAS RETURNED WITH THE GLIDEWIRE (GW) STUCK INSIDE. MULTIPLE SECTIONS OF THE GLIDEWIRE (GW) SHOWED PEELED COATING, SHAFT DEFORMATION, AND FRACTURES. THE INNER SHAFT WAS FOUND ADHERED TO THE GLIDEWIRE (GW)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077951 ↗