GUIDE WIRE M GM1811Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04987350774194), received between Jun 24, 2020 and Apr 3, 2023 — classified as 1 death, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathApr 3, 2023Break; Break

  THE USER FACILITY REPORTED THAT THEY HAD AN INCIDENT WITH THE INVOLVED 018-GOLD TIP GLIDE PRODUCT. THE GOLD TIP BROKE OFF INSIDE THE PATIENT AND WERE ABLE TO SNARE IT. THE WIRE WAS SNARED AND THERE WAS NO INJURY TO THE PATIENT. THE PATIENT WAS IN STABLE CONDITION. THE OUTCOME OF THE PROCEDURE WAS UNSUCCESSFUL. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED, AND SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2023: THE GLIDE WIRE GOLD WAS BEING USED TO CROSS A TIGHT ILIAC LESION. THE WIRE WAS ADVANCED THROUGH A 65CM KUMPE CATHETER TO THE LESION AND ADVANCED SLOWLY. THE WIRE PROLAPSED A FEW TIMES AND THEN ENGAGED THE CALCIFIED LESION. WHEN THE WIRE WOULD NOT ADVANCE ANYMORE, THE PHYSICIAN PULLED THE WIRE BACK TO TRY TO FIND A NEW CHANNEL, WHEN HE NOTICED THE GOLD MARKER WAS NOT ON THE END OF THE WIRE. UPON FURTHER INSPECTION UNDER FLOURO, THEY NOTICED THE BROKEN TIP OF THE WIRE WAS LODGED IN THE ILIAC CALCIUM, BUT ENOUGH WAS HANGING OUT THAT THEY FELT THEY COULD SNARE THE BROKEN PIECE. THEY WERE SUCCESSFUL IN CAPTURING THE BROKEN PIECE OF WIRE WITH THE SNARE AND IT WAS REMOVED FROM THE BODY AND CONFIRMED BY FLUOROSCOPY. THE BROKEN T

  Patient problems: Foreign Body In Patient

  MAUDE report 16668499 ↗
• InjuryApr 3, 2023Break; Break

  THE USER FACILITY REPORTED THAT THEY HAD AN INCIDENT WITH THE INVOLVED 018-GOLD TIP GLIDE PRODUCT. THE GOLD TIP BROKE OFF INSIDE THE PATIENT AND WERE ABLE TO SNARE IT. THE WIRE WAS SNARED AND THERE WAS NO INJURY TO THE PATIENT. THE PATIENT WAS IN STABLE CONDITION. THE OUTCOME OF THE PROCEDURE WAS UNSUCCESSFUL. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED, AND SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED 08 MAR 2023: THE GLIDE WIRE GOLD WAS BEING USED TO CROSS A TIGHT ILIAC LESION. THE WIRE WAS ADVANCED THROUGH A 65CM KUMPE CATHETER TO THE LESION AND ADVANCED SLOWLY. THE WIRE PROLAPSED A FEW TIMES AND THEN ENGAGED THE CALCIFIED LESION. WHEN THE WIRE WOULD NOT ADVANCE ANYMORE, THE PHYSICIAN PULLED THE WIRE BACK TO TRY TO FIND A NEW CHANNEL, WHEN HE NOTICED THE GOLD MARKER WAS NOT ON THE END OF THE WIRE. UPON FURTHER INSPECTION UNDER FLOURO, THEY NOTICED THE BROKEN TIP OF THE WIRE WAS LODGED IN THE ILIAC CALCIUM, BUT ENOUGH WAS HANGING OUT THAT THEY FELT THEY COULD SNARE THE BROKEN PIECE. THEY WERE SUCCESSFUL IN CAPTURING THE BROKEN PIECE OF WIRE WITH THE SNARE AND IT WAS REMOVED FROM THE BODY AND CONFIRMED BY FLUOROSCOPY. THE BROKEN T

  Patient problems: Foreign Body In Patient

  MAUDE report 16668396 ↗
• InjuryNov 14, 2021Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF THE WIRE OR MARKER BAND BROKE OFF IN THE LESION IN THE PERONEAL ARTERY DURING A PERIPHERAL VASCULAR DISEASE (PVD) INTERVENTION. THE PATIENT WAS IN GOOD CONDITION; HOWEVER, THEY WERE NOT ABLE TO COMPLETE THE INTERVENTION DUE TO EXTENSIVE DISEASE. ADDITIONAL INFORMATION WAS RECEIVED ON 22OCT2021. THE BROKEN TIP OR MARKER BAND REMAINS IN THE PATIENT. THE MARKER BAND/TIP IS IN THE PERONEAL ARTERY, LODGED WHERE IT IS OCCLUDED WITH CALCIUM. FLUORO WAS DONE TO CONFIRM THE LOCATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12808692 ↗
• InjuryNov 14, 2021Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF THE WIRE OR MARKER BAND BROKE OFF IN THE LESION IN THE PERONEAL ARTERY DURING A PERIPHERAL VASCULAR DISEASE (PVD) INTERVENTION. THE PATIENT WAS IN GOOD CONDITION; HOWEVER, THEY WERE NOT ABLE TO COMPLETE THE INTERVENTION DUE TO EXTENSIVE DISEASE. ADDITIONAL INFORMATION WAS RECEIVED ON 22-OCT-2021. THE BROKEN TIP OR MARKER BAND REMAINS IN THE PATIENT. THE MARKER BAND/TIP IS IN THE PERONEAL ARTERY, LODGED WHERE IT IS OCCLUDED WITH CALCIUM. FLUORO WAS DONE TO CONFIRM THE LOCATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12808691 ↗
• InjuryJul 27, 2020Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "TERUMO GUIDEWIRE GLIDEWIRE USED TO ADVANCE THROUGH OCCLUDED TIBIAL ARTERY. IN THE PROCESS OF REMOVING THE GLIDEWIRE THE TIP BROKE OFF IN THE TIBIAL ARTERY." THE ORIGINAL INTENDED PROCEDURE WAS A TIBIAL ANGIOPLASTY. ADDITIONAL INFORMATION WAS RECEIVED ON 21JUL2020. THERE WAS NO INTERVENTION, THE TIP REMAINED IN THE OCCLUDED TIBIAL ARTERY. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. PATIENT WEIGHT - (B)(6) KG.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10326221 ↗
• InjuryJul 27, 2020Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "TERUMO GUIDEWIRE GLIDEWIRE USED TO ADVANCE THROUGH OCCLUDED TIBIAL ARTERY. IN THE PROCESS OF REMOVING THE GLIDEWIRE THE TIP BROKE OFF IN THE TIBIAL ARTERY." THE ORIGINAL INTENDED PROCEDURE WAS A TIBIAL ANGIOPLASTY. ADDITIONAL INFORMATION WAS RECEIVED ON 21JUL2020. THERE WAS NO INTERVENTION, THE TIP REMAINED IN THE OCCLUDED TIBIAL ARTERY. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10326216 ↗
• MalfunctionJun 24, 2020Break; Detachment of Device or Device Component

  TERUMO GUIDEWIRE GLIDEWIRE USED TO ADVANCE THROUGH OCCLUDED TIBIAL ARTERY. IN THE PROCESS OF REMOVING THE GLIDEWIRE THE TIP BROKE OFF IN THE TIBIAL ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10188471 ↗