V-18 Control WireRecalls & reported problems across all models

We found 6 models of V-18 Control Wire by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 230 adverse event reports in the FDA's MAUDE database, received between Feb 24, 2016 and Sep 17, 2026 — classified as 1 death, 84 injuries, 145 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (105 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 V-18 Control Wire problems

V-18 Control Wire models

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

• V-18™ Control Wire™ M001468540

  WIRE, GUIDE, CATHETER
  1 death151 reports
• V-18™ Control Wire™ M001468520

  WIRE, GUIDE, CATHETER
  47 reports
• V-18™ Control Wire™ M001468500

  WIRE, GUIDE, CATHETER
  15 reports
• V-18™ Control Wire™ M001468600

  WIRE, GUIDE, CATHETER
  13 reports
• V-18™ Control Wire™ M001468480

  WIRE, GUIDE, CATHETER
  3 reports
• V-18™ Control Wire™ M001468580

  WIRE, GUIDE, CATHETER
  1 report

Recent V-18 Control Wire adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810491 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810327 ↗
• MalfunctionSep 3, 2026Detachment of Device or Device Component

  It was reported that device detachment occurred.A V-18 Control Wire was selected for use during an obliterative arteriopathy of the lower extremities, which required angioplasty of the proximal fibular artery. During the procedure, a fragment of the guidewire detached and remained in the patients popliteal artery. It was noted that the fragment was not retrieved because it was microscopic and deemed harmless by the doctors. The patient was discharged and prescribed a 7 day treatment with antibiotics (Augmentin). No changes were made to the anticoagulant treatment.

  Patient problems: Foreign Body In Patient

  MAUDE report 50587899 ↗
• InjurySep 2, 2026Detachment of Device or Device Component

  It was reported that the guidewire fractured requiring additional intervention.The target lesion was a Chronic Total Occlusion (CTO) and located in the superior mesenteric artery (SMA). A V-18 Control Wire was advanced to cross the lesion during an SMA stenting procedure. While crossing the lesion, the tip of the guidewire fractured. The fractured tip was successfully snared and removed. The procedure was completed using another V-18 Control Wire. There were no patient complications as a result of the event..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569938 ↗
• 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 ↗
• MalfunctionAug 20, 2026Material Integrity Problem

  The coating of the wire distal is removed from the patient's body during the procedure. The 70% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel. A 300cm, 8cm V-18 Control Wire was selected for use in an angioplasty procedure in the leg. During the procedure, the distal coating of the guidewire was removed from the patients body. The procedure was completed using with another of the same device and there were no patient complications as a result of this event. It was further reported that the distal coating of the guidewire appeared to peel. Resistance or unusual difficulty was encountered during advancement, manipulation of the guidewire. The coating removal occurred at the distal tip of the guidewire.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50349118 ↗
• MalfunctionAug 13, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240191 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE BIFURCATION OCCURRED. A 300CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE IN A BALLOON ANGIOPLASTY. DURING THE PROCEDURE, THE DISTAL END OF THE GUIDEWIRE WAS OBSERVED TO BE BIFURCATED. THE PROCEDURE WAS COMPLETED WITH A NEW HYDROPHILIC-COATED STEERABLE GUIDEWIRE. NO PATIENT COMPLICATIONS OR HARM WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261269 ↗
• InjuryJan 8, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 300CM, 8CM V-18 CONTROL WIRE GUIDEWIRE WAS SELECTED TO TREAT PERIPHERAL ARTERY DISEASE (PAD) IN AN ENDOVASCULAR THERAPY (EVT). DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE BECAME LODGED IN A BRANCH. TO EXTRACT IT, THE GUIDEWIRE WAS PULLED, RESULTING IN ITS REMOVAL FROM THE MICROCATHETER. AT THAT POINT, IT WAS DISCOVERED THAT THE TIP OF THE GUIDEWIRE REMAINED IN THE SFA, CONFIRMING A FRACTURE. A GOOSENECK SNARE WAS USED TO RETRIEVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND A STENT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004882 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 300CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURAL PREPARATION, THE PHYSICIAN DISCOVERED THAT THE GUIDEWIRE HAD FRACTURED PRIOR TO USE. THE GUIDEWIRE WAS IMMEDIATELY REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872595 ↗
• InjuryDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GUIDEWIRE BROKE. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS BROKE AND THE BROKEN SEGMENT WAS IMMEDIATELY REMOVED, PREVENTING A POTENTIALLY IRREVERSIBLE COMPLICATION CAUSING EXTENSION OF THE PROCEDURE TIME. A NEW GUIDEWIRE WAS PROMPTLY REPLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864813 ↗
• InjuryDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED REQUIRING INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP PART OF THE DEVICE WAS SEPARATED. THERE WAS RESISTANCE IN REMOVING THE DEVICE AND THE DEVICE PART WAS CAUGHT WITH A SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT NO REMNANTS OF THE DETACHED TIP REMAINED INSIDE THE PATIENT'S BODY, AS THE DETACHED PORTION WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. DURING THE PROCEDURE, THE V-18 GUIDEWIRE WAS USED SPECIFICALLY IN THE ANTERIOR TIBIAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850310 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, AND THE DEVICE FRAGMENT WAS NOT RETRIEVED. A 300 CM, 8 CM V-18 CONTROL WIRE WAS SELECTED FOR USE IN A PERIPHERAL ANGIOGRAM WITH INTERVENTION PROCEDURE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY (PTA). THE WIRE WAS MANIPULATED PRIOR TO INSERTION TO CREATE AN ANGLE AND WAS USED IN A CHALLENGING CHRONIC TOTAL OCCLUSION (CTO). THE WIRE WAS INTRODUCED THROUGH AN INTRODUCER TO SHAPE THE TIP, THEN ADVANCED THROUGH A 6F SHEATH AND A NON-BOSTON SCIENTIFIC SUPPORT CATHETER. DURING NAVIGATION, THE DISTAL TIP OF THE WIRE DETACHED IN THE PTA AND WAS LEFT IN THE VESSEL. A NEW V-18 CONTROL WIRE WAS SUBSEQUENTLY INSERTED, AND THE PROCEDURE CONTINUED; HOWEVER, THE VESSEL COULD NOT BE OPENED, WHICH WAS UNRELATED TO DEVICE PERFORMANCE, AS THE ARTERY WAS COMPLETELY OCCLUDED FROM THE START. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 23768366 ↗
• MalfunctionDec 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT AN ISSUE INVOLVING THE GUIDEWIRE COATING OCCURRED. A 300CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE IN A BALLOON DILATATION PROCEDURE OF THE LEFT LOWER LIMB. A SUPPORTING CATHETER WAS UTILIZED TO ACCESS AND OPEN THE VESSEL OVER THE 0.018 GUIDEWIRE. AFTER THE GUIDEWIRE ENTERED THE PATIENT, THE COATING WAS OBSERVED TO HAVE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. IT WAS FURTHER REPORTED THAT THE SOFT TIP AT THE FRONT END OF THE GUIDEWIRE PEELED OFF DURING THE PROCEDURE, AND THE COATING ON THE POSTERIOR PART OF THE GUIDEWIRE WAS FOUND TO BE DETACHED. THIS DAMAGE OCCURRED DURING USE. THE LESION ITSELF WAS NOT PARTICULARLY CHALLENGING, AND THE PATIENTS ANATOMY DID NOT CONTRIBUTE TO THE ISSUE. THE GUIDEWIRE WAS INSERTED THROUGH AN 18-FRENCH SUPPORT CATHETER BUT BECAME STUCK AT THE DISTAL END. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE GUIDEWIRE, THE COATING AT THE DISTAL END FRACTURED. THE EVENT WAS NOT ATTRIBUTED TO ANY PATIENT FACTORS, AND PROCEDURAL FACTORS WERE NOT BELIEVED TO HAVE CONTRIBUTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760193 ↗
• 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 ↗

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