V-18™ Control Wire™ M001468600Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729070238), received between Feb 24, 2016 and Sep 2, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Detachment of Device or Device Component

  It was reported that guidewire fracture requiring additional intervention. The target lesion was located in a lower extremity artery. A 300cm, 12cm V-18 guidewire was advanced for lesion crossing; however, during crossing, the tip of the guidewire fractured and detached inside the patients vessel. The physician successfully snared and removed the detached fragment, and another V-18 guidewire was used to complete the procedure. No patient complications and the patient was stable as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566529 ↗
• InjuryDec 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GUIDEWIRE DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. DURING AN ENDOVASCULAR PROCEDURE, A FRAGMENT OF A 300 CM, 12 CM POLY TIP V-18 CONTROL WIRE BROKE OFF IN THE PATIENT. THE SURGEONS IMMEDIATELY RECOGNIZED THE ISSUE AND USED A SNARE TO RETRIEVE THE DETACHED PIECE. A FLUOROSCOPIC RUN WAS PERFORMED TO CONFIRM COMPLETE REMOVAL OF THE FRAGMENT. BOTH WIRE AND BROKEN PIECE WERE INSPECTED AND CONFIRMED ALL REMOVED. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756400 ↗
• InjuryMar 19, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION, WHICH WAS 100% STENOSED, WAS SITUATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 300 CM, 12 CM POLY TIP V-18 CONTROL WIRE WAS UTILIZED DURING THE PROCEDURE. DURING THE INTERVENTION, THE WIRE WAS KNUCKLED AND LASED, HOWEVER, IT WAS OBSERVED THAT THE DISTAL TIP OF THE WIRE BECAME DETACHED. A COVERED STENT WAS USED PLACED AS A RESULT. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21643518 ↗
• InjuryJan 30, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT TIP DETACHMENT OCCURRED, REQUIRING SNARE FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 300CM, 12CM V-18 CONTROL WIRE WAS SELECTED FOR ANGIOGRAPHIC PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE TANGLED, AND THE TIP OF THE GUIDEWIRE BROKE OFF INSIDE THE PATIENT. A SNARE WAS USED TO REMOVE THE REMAINING WIRE, EXTENDING THE PROCEDURE. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE BODY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277028 ↗
• InjuryMay 2, 2024Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  IT WAS REPORTED VIA ATTACHED VOLUNTARY MEDWATCH REPORT # MW5153140 THAT GUIDEWIRE FRAYED AND HAS SHEARED OFF AND REMAINED INSIDE PATIENT. A 300CM, 12CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS FRAYED. THE IMAGING SHOWED A THREAD LIKE PICE SHEARED OFF AND WAS LEFT INSIDE THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19234885 ↗
• InjuryJan 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. PHYSICIAN WAS PERFORMING A LOWER EXTREMITY PULMONARY VEIN ISOLATION (PVI). A 300CM, 12CM V-18 CONTROL WIRE WAS USED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE WAS FRACTURED. THE DEVICE WAS THEN REMOVED BUT THE TIP WAS RETAINED IN THE VESSEL. THE DETACHED TIP COULD NOT BE RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED AFTER THE TIP DETACHMENT AND THE PATIENT FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13334089 ↗
• MalfunctionNov 20, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT GUIDE WIRE REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. TWO V-18 300CM 12CM CONTROL WIRES WERE ADVANCED ONE AT A TIME TO CROSS THE LESION. HOWEVER, UPON REMOVAL, THE TIP WAS BENT AND THE WIRES WOULD NOT RETURN THROUGH THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9348631 ↗
• MalfunctionNov 20, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT GUIDE WIRE REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. TWO V-18 300CM 12CM CONTROL WIRES WERE ADVANCED ONE AT A TIME TO CROSS THE LESION. HOWEVER, UPON REMOVAL, THE TIP WAS BENT AND THE WIRES WOULD NOT RETURN THROUGH THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9348628 ↗
• InjuryJun 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT POSTERIOR TIBIAL ARTERY. A V-18, 300CM, 12CM POLY TIP CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE TIP OF THE WIRE WAS CAUGHT ON A CALCIUM AND SHEERED OFF. THE DETACHED TIP WAS RETRIEVED BY SNARING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY OR ADVERSE EVENT WERE REPORTED AND PATIENT WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8731765 ↗
• InjuryFeb 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. THE 90% TO 100% STENOSED TARGET LESION WERE LOCATED IN THE MILDLY TORTUOUS COMMON ILIAC, EXTERNAL ILIAC AND COMMON FEMORAL VEIN. A 300CM, 12CM POLY TIP V-18 CONTROL WIRE WAS ADVANCED TO CROSS THE OCCLUSION. HOWEVER, IT WAS NOTED THAT THE TIP OF THE WIRE GOT STUCK IN THE OCCLUSION AND THE BACK PART BUCKLED. WHEN THE WIRE WAS PULLED BACK, IT WAS NOTICED THAT THE TIP HAD BROKEN OFF. A SNARE WAS ADVANCED TOWARDS THE BROKEN OFF TIP BUT COULDN'T GET THE DETACHED FRAGMENT. MULTIPLE ATTEMPTS WERE MADE TO CROSS THE OCCLUSION BUT FAILED, SO THE PROCEDURE WAS STOPPED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8336438 ↗
• InjuryDec 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL BELOW THE KNEE. A 300CM, 12CM V-18 CONTROL WIRE WAS ADVANCED TO THE LESION. HOWEVER, IT WAS NOTED THAT THE TIP OF THE WIRE BROKE OFF WHILE INSIDE THE PATIENT'S FOOT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY. THE PROCEDURE PERFORMED WAS FOR A RETROGRADE CANNULATION. AFTER THE TIP BROKE, THE SURGEON DECIDED THAT THE TIP WOULD BE LEFT IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8165272 ↗
• InjurySep 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT COMMON FEMORAL ARTERY. A 300 CM, 12 CM V-18 CONTROL WIRE GUIDE WIRE WAS CROSSED THE LESION. HOWEVER, THE DISTAL TIP AT AROUND 9 CM OF THE WIRE SHEARED OFF INSIDE THE PATIENT. THE FRAGMENT WAS LEFT IN THE SUBINTIMAL SPACE. NO INTERVENTION WAS DONE IN AN ATTEMPT TO REMOVE THE SHEARED COMPONENT. THE PHYSICIAN NOTED THAT THE FRAGMENT WAS NOT IN JEOPARDY OF MIGRATING AND IT WOULD NOT CAUSE ANY HARM; THEREFORE, THE PHYSICIAN DECIDED THAT IT WAS BEST TO KEEP IT THERE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE AND GOOD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7846214 ↗
• InjuryFeb 24, 2016Break

  TIP OF BOSTON SCIENTIFIC V-18 CONTROL WIRE BROKE OFF DURING FEMORAL ANGIOPLASTY. TIP HAD TO BE JAILED AGAINST VESSEL WALL WITH STENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5462883 ↗