GUIDE WIRE M GM1813Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350774231), received between Dec 16, 2016 and Jul 4, 2025 — classified as 2 injuries, 1 malfunction.

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

• InjuryJul 4, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS PERFORMING A RIGHT LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. THE PHYSICIAN GAINED ACCESS IN THE LEFT COMMON FEMORAL ARTERY, FOR UP AND OVER ACCESS TO THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO CROSS A LONG SEGMENT CHRONIC TOTAL OCCLUSION (CTO) LESION THAT BEGAN IN THE P1 SEGMENT OF THE POPLITEAL ARTERY AND EXTENDED ABOUT HALFWAY DOWN INTO ALL OF THE TIBIAL VESSELS. RETROGRADE TIBIAL ACCESS WAS GAINED IN BOTH THE DISTAL ANTERIOR TIBIAL ARTERY AS WELL AS THE DISTAL POSTERIOR TIBIAL ARTERY WITH COOK PEDAL ACCESS SHEATHS. A 0.018 90CM STRAIGHT NAVICROSS AND 0.018 GLIDEWIRE GOLD WERE USED TO ATTEMPT TO RECANNULATE THE POSTERIOR TIBIAL ARTERY INTO THE POPLITEAL. THE PHYSICIAN WAS BEING FAIRLY AGGRESSIVE WITH TRYING TO GET THRU THE CHRONIC TOTAL OCCLUSION (CTO), AS THE PATIENT WAS NOT A VASCULAR SURGICAL CANDIDATE. TOWARDS THE VERY END OF THE PROCEDURE, IT WAS NOTICED THAT THE DISTAL TIP OF THE GLIDEWIRE GOLD WIRE HAD BROKEN OFF IN THE RIGHT LOWER EXTREMITY WHERE THE TIBIOPERONEAL TRUNK WOULD HAVE BEEN. THE LENGTH OF THE WIRE LEFT WAS MEASURED TO BE APPROXIMATELY 8-9MM. THE PHYSICIANS

  Patient problems: Foreign Body In Patient

  MAUDE report 22406876 ↗
• InjuryJul 4, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS PERFORMING A RIGHT LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. THE PHYSICIAN GAINED ACCESS IN THE LEFT COMMON FEMORAL ARTERY, FOR UP AND OVER ACCESS TO THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO CROSS A LONG SEGMENT CHRONIC TOTAL OCCLUSION (CTO) LESION THAT BEGAN IN THE P1 SEGMENT OF THE POPLITEAL ARTERY AND EXTENDED ABOUT HALFWAY DOWN INTO ALL OF THE TIBIAL VESSELS. RETROGRADE TIBIAL ACCESS WAS GAINED IN BOTH THE DISTAL ANTERIOR TIBIAL ARTERY AS WELL AS THE DISTAL POSTERIOR TIBIAL ARTERY WITH COOK PEDAL ACCESS SHEATHS. A 0.018 90CM STRAIGHT NAVICROSS AND 0.018 GLIDEWIRE GOLD WERE USED TO ATTEMPT TO RECANNULATE THE POSTERIOR TIBIAL ARTERY INTO THE POPLITEAL. THE PHYSICIAN WAS BEING FAIRLY AGGRESSIVE WITH TRYING TO GET THRU THE CHRONIC TOTAL OCCLUSION (CTO), AS THE PATIENT WAS NOT A VASCULAR SURGICAL CANDIDATE. TOWARDS THE VERY END OF THE PROCEDURE, IT WAS NOTICED THAT THE DISTAL TIP OF THE GLIDEWIRE GOLD WIRE HAD BROKEN OFF IN THE RIGHT LOWER EXTREMITY WHERE THE TIBIOPERONEAL TRUNK WOULD HAVE BEEN. THE LENGTH OF THE WIRE LEFT WAS MEASURED TO BE APPROXIMATELY 8-9MM. THE PHYSICIANS

  Patient problems: Foreign Body In Patient

  MAUDE report 22406875 ↗
• MalfunctionDec 16, 2016Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED GUIDEWIRE DEVICE WAS FRACTURED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE DOCTOR WAS USING THE GLIDEWIRE M/GOLD ON A NEPHROSTOMY AND THE PRODUCT SPLAYED OPEN; THE PATIENT WENT HOME THE SAME DAY; THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED; AND THE PROCEDURE OUT WAS REPORTED TO BE POSITIVE. ADDITIONAL INFORMATION WAS OBTAINED FROM THE RADIOLOGY TECH ON DECEMBER 9TH, 2016: HE STATED THAT AFTER THE WIRE WAS REMOVED, IT LOOKED LIKE THE BLACK OUTER COATING WAS SPLIT NEAR THE DISTAL END AND THERE WAS NO OTHER DAMAGE NOTED. THERE WAS A SHEATH AND CATHETER USED WITH THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6180732 ↗