GUIDE WIRE M GM1831Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04987350711908), received between Dec 15, 2017 and Jul 11, 2025 — classified as 16 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR HAD RIGHT GROIN ACCESS TO INTERVENE ON A CRITICAL LIMB ISCHEMIA (CLI). THE PT VESSEL WAS OCCLUDED, THE DOCTOR TRIED TO CROSS A HEAVY CALCIFIED LESION WITH A .018 COMMAND AND DID NOT CROSS, THEY THEN ESCALATED TO .018 GLIDEWIRE GOLD. THE GLIDEWIRE GOLD ENTERED INTO LESION HOWEVER, IT WOULD NOT ADVANCE. THE DOCTOR REMOVED THE GM1831, HOWEVER THE DISTAL TIP DETACHED AND REMAINED IN THE LESION. THE REMAINING WIRE WAS REMOVED. THE DOCTOR ATTEMPTED TO SNARE AND RETRIEVE THE DISTAL TIP STUCK IN THE OCCLUSION VIA FEM ACCESS AND ALTERNATIVE DISTAL ACCESS, HOWEVER, WAS UNEVENTFUL ON EACH. THE REMAINING DISTAL TIP OF THE GM1831 REMAINED IN THE PATIENT AT THE MID PT LESION. THE EVENT OCCURRED PRIOR TO THE TERUMO REPRESENTATIVE BEING IN THE ROOM. THE DOCTOR DID INTERVENE ELSEWHERE WITH SHOCKWAVE, ARMADA BALLOONS, MEDTRONIC DRUG COATED BALLOON (DCB) IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THEY CLOSED WITH A MYNX. THE PATIENT WILL BE MONITORED AND DID NOT GO TO SURGERY. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 17JUN2025: THE PATIENT WAS IN STABLE CONDITION. THEY WERE GOING TO WATCH AND WAIT TO SEE HOW FOOT WOUND HEALS; FURTHER INT

  Patient problems: Foreign Body In Patient

  MAUDE report 22487944 ↗
• InjuryJul 11, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR HAD RIGHT GROIN ACCESS TO INTERVENE ON A CRITICAL LIMB ISCHEMIA (CLI). THE PT VESSEL WAS OCCLUDED, THE DOCTOR TRIED TO CROSS A HEAVY CALCIFIED LESION WITH A .018 COMMAND AND DID NOT CROSS, THEY THEN ESCALATED TO .018 GLIDEWIRE GOLD. THE GLIDEWIRE GOLD ENTERED INTO LESION HOWEVER, IT WOULD NOT ADVANCE. THE DOCTOR REMOVED THE GM1831, HOWEVER THE DISTAL TIP DETACHED AND REMAINED IN THE LESION. THE REMAINING WIRE WAS REMOVED. THE DOCTOR ATTEMPTED TO SNARE AND RETRIEVE THE DISTAL TIP STUCK IN THE OCCLUSION VIA FEM ACCESS AND ALTERNATIVE DISTAL ACCESS, HOWEVER, WAS UNEVENTFUL ON EACH. THE REMAINING DISTAL TIP OF THE GM1831 REMAINED IN THE PATIENT AT THE MID PT LESION. THE EVENT OCCURRED PRIOR TO THE TERUMO REPRESENTATIVE BEING IN THE ROOM. THE DOCTOR DID INTERVENE ELSEWHERE WITH SHOCKWAVE, ARMADA BALLOONS, MEDTRONIC DRUG COATED BALLOON (DCB) IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THEY CLOSED WITH A MYNX. THE PATIENT WILL BE MONITORED AND DID NOT GO TO SURGERY. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 17JUN2025: THE PATIENT WAS IN STABLE CONDITION. THEY WERE GOING TO WATCH AND WAIT TO SEE HOW FOOT WOUND HEALS; FURTHER INT

  Patient problems: Foreign Body In Patient

  MAUDE report 22487943 ↗
• MalfunctionNov 4, 2024Separation Problem; Separation Problem

  THE USER FACILITY THAT THE GLIDEWIRE GOLD WAS BEING USED IN CONJUNCTION WITH THE 108 NAVICROSS AND IT BEGAN TO GET A LITTLE STICKY INSIDE THE MICROCATHETER AND THEN WHEN THEY PULLED THE WIRE OUT. THERE WAS A LOT OF TENSION, THE WIRE HAD SEPARATED AND EXPOSED THE CORE OF THE WIRE AND THE COATING WAS PULLED OFF. THE PROCEDURE TYPE WAS AN LOWER EXTREMITY (LE) ANGIOGRAM. THERE WAS NO BLOOD LOSS AND THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 09OCT2024: THE WIRE WAS USED IN THE PATIENT'S BODY AND THERE WAS NO INFECTIOUS AGENTS NOR ANTI-CANCER AGENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605832 ↗
• MalfunctionOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE PATIENT EXPERIENCED HEMOPTYSIS DURING THE CARDIOMEMS IMPLANT PROCEDURE. THE HEMOPTYSIS OCCURRED PRIOR TO CARDIOMEMS INSERTION, SHORTLY AFTER THE PHYSICIAN OBTAINED THE PATIENT'S WEDGE PRESSURE USING A MULTIPURPOSE CATHETER. THE SENSOR WAS SUCCESSFULLY DEPLOYED AND CALIBRATED. THE PATIENT WAS GIVEN SUPPLEMENTAL OXYGEN AND WAS ADMITTED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. NO FURTHER INFORMATION COULD BE OBTAINED. THE TERUMO WIRE WAS USED FOR THE PROCEDURE.

  Patient problems: Hemoptysis

  MAUDE report 20356325 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE PATIENT EXPERIENCED HEMOPTYSIS DURING THE CARDIOMEMS IMPLANT PROCEDURE. THE HEMOPTYSIS OCCURRED PRIOR TO CARDIOMEMS INSERTION, SHORTLY AFTER THE PHYSICIAN OBTAINED THE PATIENT'S WEDGE PRESSURE USING A MULTIPURPOSE CATHETER. THE SENSOR WAS SUCCESSFULLY DEPLOYED AND CALIBRATED. THE PATIENT WAS GIVEN SUPPLEMENTAL OXYGEN AND WAS ADMITTED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. NO FURTHER INFORMATION COULD BE OBTAINED. THE TERUMO WIRE WAS USED FOR THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20356322 ↗
• InjuryNov 16, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE GLIDEWIRE GOLD BROKE OFF INSIDE THE PATIENT. THEY WERE ABLE TO RETRIEVE THE TIP OUT OF THE PATIENT. THERE WAS CALCIUM IN THE PATIENT'S ARTERY, AND THE WAY THE WIRE WAS MANIPULATED CAUSED IT TO BREAK OFF. THERE WAS NO ESTIMATED BLOOD LOSS. THERE WAS NO SURGICAL INTERVENTION REQUIRED. THERE WAS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 30OCT2023: THE PROCEDURE WAS A PERIPHERAL. A SNARE WAS USED TO REMOVE THE BROKEN TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 18148621 ↗
• InjuryNov 16, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE GLIDEWIRE GOLD BROKE OFF INSIDE THE PATIENT. THEY WERE ABLE TO RETRIEVE THE TIP OUT OF THE PATIENT. THERE WAS CALCIUM IN THE PATIENT'S ARTERY, AND THE WAY THE WIRE WAS MANIPULATED CAUSED IT TO BREAK OFF. THERE WAS NO ESTIMATED BLOOD LOSS. THERE WAS NO SURGICAL INTERVENTION REQUIRED. THERE WAS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 30OCT2023: THE PROCEDURE WAS A PERIPHERAL. A SNARE WAS USED TO REMOVE THE BROKEN TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 18148582 ↗
• InjuryOct 5, 2023Break; Break

  THE USER FACILITY REPORTED THAT DURING A PERIPHERAL CASE, THE DISTAL TIP PAST THE MARKER BAND BROKE ON THE WIRE. THE PATIENT WAS OK AND PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITION INFORMATION WAS RECEIVED ON 15SEPT2023: PER THE PHYSICIAN A VERY SMALL AMOUNT OF THE WIRE WAS LEFT IN THE PATIENT POST PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17880911 ↗
• InjuryOct 5, 2023Break; Break

  THE USER FACILITY REPORTED THAT DURING A PERIPHERAL CASE, THE DISTAL TIP PAST THE MARKER BAND BROKE ON THE WIRE. THE PATIENT WAS OK AND PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITION INFORMATION WAS RECEIVED ON 15SEPT2023: PER THE PHYSICIAN A VERY SMALL AMOUNT OF THE WIRE WAS LEFT IN THE PATIENT POST PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17880800 ↗
• MalfunctionJul 19, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE GOLD BROKE OFF INSIDE OF A QUICKCROSS CATHETER DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THEY WERE ABLE TO REMOVE THE CATHETER WITH WIRE AND CONTINUED THE CASE. ADDITIONAL INFORMATION WAS RECEIVED ON 06JUL2023: THE PROCEDURE BEING PERFORMED WAS A LOWER EXTREMITY ANGIOGRAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17355869 ↗
• InjuryMay 16, 2023Break; Break

  THE USER FACILITY REPORTED THAT UPON ADVANCING THE GUIDEWIRE INVOLVED, THE TIP BROKE OFF AT AN OCCLUDED AREA OF THE VESSEL. THE DOCTOR DETERMINED IT WAS BEST TO LEAVE THE TIP IN THE PATIENT. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS FINE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THE DOCTOR WAS DOING ROUTINE WORK. THE DOCTOR REPORTED THAT HE WAS NOT TUGGING OR PUSHING HARD. THE PROCEDURE WAS AN ANGIOGRAM OF THE LEG, AND THE WIRE BROKE IN THE POPLITEAL AREA. THERE WAS CALCIFICATION AND THE DOCTOR WAS TRYING TO CROSS THE LESION; HOWEVER, THE DOCTOR DID NOT DO ANYTHING OUT OF THE ORDINARY, AND IT WAS NOT IN VERY LONG, ONLY A FEW MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 16938761 ↗
• InjuryMay 16, 2023Break; Break

  THE USER FACILITY REPORTED THAT UPON ADVANCING THE GUIDEWIRE INVOLVED, THE TIP BROKE OFF AT AN OCCLUDED AREA OF THE VESSEL. THE DOCTOR DETERMINED IT WAS BEST TO LEAVE THE TIP IN THE PATIENT. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS FINE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 28 APR 2023: THE DOCTOR WAS DOING ROUTINE WORK. THE DOCTOR REPORTED THAT HE WAS NOT TUGGING OR PUSHING HARD. THE PROCEDURE WAS AN ANGIOGRAM OF THE LEG, AND THE WIRE BROKE IN THE POPLITEAL AREA. THERE WAS CALCIFICATION AND THE DOCTOR WAS TRYING TO CROSS THE LESION; HOWEVER, THE DOCTOR DID NOT DO ANYTHING OUT OF THE ORDINARY, AND IT WAS NOT IN VERY LONG, ONLY A FEW MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 16938694 ↗
• InjuryApr 26, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE GOLD TIP DETACHED FROM THE WIRE WHEN DOING A PERIPHERAL ARTERY DISEASE (PAD) CASE. THE WIRE WAS DEPLOYED THROUGH AN 018 NAVICROSS. GLIDESHEATH SLENDER TP WAS THE SHEATH USED IN THE CASE FROM A PEDAL APPROACH. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THE DOCTOR STATED THEY THOUGHT THE TIP MIGHT HAVE BEEN LEFT/STUCK IN THE SHEATH AND NOT IN THE PATIENT. UNDER X-RAY, THEY CANNOT SEE THE TIP. THE WIRE WAS RETRIEVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16818665 ↗
• InjuryApr 26, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE GOLD TIP DETACHED FROM THE WIRE WHEN DOING A PERIPHERAL ARTERY DISEASE (PAD) CASE. THE WIRE WAS DEPLOYED THROUGH AN 018 NAVICROSS. GLIDESHEATH SLENDER TP WAS THE SHEATH USED IN THE CASE FROM A PEDAL APPROACH. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023. THE DOCTOR STATED THEY THOUGHT THE TIP MIGHT HAVE BEEN LEFT/STUCK IN THE SHEATH AND NOT IN THE PATIENT. UNDER X-RAY, THEY CANNOT SEE THE TIP. THE WIRE WAS RETRIEVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16818320 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE COATING ON THE PROXIMAL PART OF THE GUIDEWIRE INVOLVED STARTED TO SCRAPE OFF AS A .018 ANGLED CROSSING CATHETER WAS BEING LOADED ON TO IT. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 14 FEB 2022: THE PROCEDURE PERFORMED WAS A LEG ANGIO. THE PROCEDURE WAS COMPLETED USING THE GUIDEWIRE INVOLVED AFTER IT WAS DEEMED AS SCRAPED BY THE ANGLED TIP OF THE NAVICROSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619032 ↗
• InjuryNov 15, 2021Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE GOLD TIP SHEARED OFF THE WIRE DURING THE PROCEDURE. THE TIP OF THE WIRE WENT OFF IN A BRANCH OF THE PROFUNDA, SO IT CAUSED NO HARM TO PATIENT, HOWEVER, THEY WERE NOT ABLE TO RETRIEVE THE WIRE TIP. THE SMALL BRANCH WAS FEEDING NOWHERE SO IT CAUSED NO HARM. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 29-OCT-2021. THE PROCEDURE WAS A PERIPHERAL ARTERY DISEASE (PAD) CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12813536 ↗
• InjuryNov 15, 2021Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE GOLD TIP SHEARED OFF THE WIRE DURING THE PROCEDURE. THE TIP OF THE WIRE WENT OFF IN A BRANCH OF THE PROFUNDA, SO IT CAUSED NO HARM TO PATIENT, HOWEVER, THEY WERE NOT ABLE TO RETRIEVE THE WIRE TIP. THE SMALL BRANCH WAS FEEDING NOWHERE SO IT CAUSED NO HARM. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. THE PROCEDURE WAS A PERIPHERAL ARTERY DISEASE (PAD) CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12813518 ↗
• InjuryNov 1, 2021Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPY PROCEDURE, THE GUIDEWIRE TIP BROKE/SHEARED OFF. THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER FACILITY AS A RESULT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12730749 ↗
• InjuryNov 1, 2021Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPY PROCEDURE, THE GUIDEWIRE TIP BROKE/SHEARED OFF. THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER FACILITY AS A RESULT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12730649 ↗
• MalfunctionAug 1, 2018Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT A MALFUNCTION OCCURRED WHEN USING THE INVOLVED GLIDEWIRE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN WAS DOING A LOWER EXTREMITY PROCEDURE IN WHICH THE PATIENT HAD IN-STENT RESTENOSIS. THE DOCTOR ADVANCED THE GLIDEWIRE GOLD INSIDE OF AN .018 QUICK CROSS TO THE LESION AND TRIED TO CROSS THE LESION. WHEN THE DOCTOR TRIED TO PULL BACK THE WIRE, THEY NOTICED THAT THERE WAS A "WIRE MALFUNCTION" WITH THE WIRE AND HAD TO PULL OUT THE WHOLE SYSTEM IN ORDER TO RETRIEVE THE WIRE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/18/2018: NONE OF THE COATING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE AND IT WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 7/19/2018: THE "WIRE MALFUNCTION" WAS THE POLYURETHANE COATING WAS COMING OFF OF THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7740862 ↗
• InjuryDec 15, 2017Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 12/5/17. THE TIP WAS NOT RETRIEVED FROM THE PATIENT. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250 CC. THE PATIENT CONDITION IS STABLE. IT WAS REPORTED THAT THE WIRE TIP WAS NOT RETRIEVED AND WAS UNABLE TO DILATE LESION.

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 7121905 ↗