JUDO™ 3 H749393771900Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729974949), received between Nov 25, 2019 and Dec 22, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A VASOSPASM OCCURRED AND REQUIRED MEDICATION. A 190 CM JUDO 3 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE ADVANCED TO THE GUIDING CATHETER, BUT IT FAILED TO CROSS SMOOTHLY, AND VASOSPASM OCCURRED. VASOSPASM WAS TREATED WITH NITROGLYCERIN. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE DEVICE. THE PATIENT RECOVERED AND WAS GOOD POST PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 18383682 ↗
• InjuryNov 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE OVER 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 190 CM, STRAIGHT TIP, JUDO 3 GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS WITHDRAWN FROM THE PATIENT'S BODY, THE SPRING COIL SECTION OF THE GUIDEWIRE FRACTURED AROUND 180CM. THE DEVICE WAS REMOVED USING GUIDEZILLA (GZ), LOWER BALLOON WITH LOW PRESSURE DILATION AND RETRACTION REMOVAL. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC (BSC) DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AND THE PATIENT WAS IN GOOD CONDITION. IT WAS FURTHER REPORTED THAT THERE ARE NO OBVIOUS COMPLICATIONS, AND THE IMMEDIATE MANIFESTATION WAS VASOSPASM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vasoconstriction

  MAUDE report 18226917 ↗
• InjuryJan 27, 2021Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND DISTAL TIP DETACHMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 3, 190 CM JUDO 3 GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, THE WIRE BECAME STUCK IN THE SUBINTIMAL PLAQUE AND THE DISTAL PORTION UNRAVELED. THE PHYSICIAN TRIED TO RETRIEVE THE DISTAL TIP BY BALLOONING PROXIMALLY BUT EVERYTHING CAME OUT AND THE RADIOPAQUE PORTION BROKE OFF. THE DETACHED COMPONENT HAS BEEN STENTED ACROSS AND BURIED IN CALCIUM. THE PROCEDURE WAS COMPLETED BY GOING RETROGRADE AND THE SHEARED OFF PORTION OF THE WIRE REMAINS IN THE RIGHT CORONARY ARTERY BEHIND A STENT. NO COMPLICATIONS WERE REPORTED AND PATIENT IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 11238795 ↗
• InjuryNov 25, 2019Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A CTO LESION IN THE CIRCUMFLEX CORONARY ARTERY. A JUDO 3 GUIDEWIRE WAS ABLE TO CROSS THE LESION BUT THE WIRE PROLAPSED AND BECAME TANGLED. THE BODY OF THE GUIDEWIRE WAS INSIDE A MICROCATHETER, BUT THE TIP OF THE GUIDEWIRE WAS OUTSIDE OF THE MICROCATHETER. THE GUIDEWIRE WAS UNABLE TO BE PULLED INTO THE MICROCATHETER AND AS THEY WERE REMOVING EVERYTHING FROM THE BODY, THE GUIDEWIRE TIP GOT STUCK ON THE PREVIOUSLY PLACED STENT STRUT AND IT SNAPPED OFF. THE GUIDEWIRE TIP WAS LEFT INSIDE THE BODY. THE PHYSICIAN ATTEMPTED TO SNARE THE TIP OF THE GUIDEWIRE BUT WAS NOT ABLE TO DO SO. THE PHYSICIAN PLACED A SECOND STENT INSIDE THE PREVIOUSLY PLACED STENT SO THROMBUS WOULD NOT FORM ON THE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9371581 ↗