GUIDE WIRE MRecalls & reported problems across all models

We found 6 models of GUIDE WIRE M by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2016 and Jul 11, 2025 — classified as 1 death, 29 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GUIDE WIRE M problems

GUIDE WIRE M models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GUIDE WIRE M GM1831

  Laparoscope, general & plastic surgery
  21 reports
• GUIDE WIRE M GM1811

  Laparoscope, general & plastic surgery
  1 death7 reports
• GUIDE WIRE M GM1813

  Laparoscope, general & plastic surgery
  3 reports
• GUIDE WIRE M GM1832

  WIRE, GUIDE, CATHETER
  2 reports
• GUIDE WIRE M GM1833

  WIRE, GUIDE, CATHETER
  2 reports
• GUIDE WIRE M GM1834

  Laparoscope, general & plastic surgery
  2 reports

Recent GUIDE WIRE M adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗

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