V-14™ Control Wire™ H74939216930020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729799276), received between Oct 15, 2019 and Oct 15, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 18, 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.

• MalfunctionOct 15, 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 GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH COLD LEG AND UNDERWENT ANGIOGRAM. THE TARGET LESIONS WERE LOCATED IN THE 99% OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA) AND 100% OCCLUDED POSTERIOR TIBIAL ARTERY (PTA). THE LESION CHARACTERISTICS WERE MODERATELY TORTUOUS AND MODERATELY CALCIFIED. AFTER ADVANCING A 300CM ANGLED TIP V-14 CONTROL WIRE, A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED OVER THE WIRE; HOWEVER, RESISTANCE WAS NOTED. FOLLOWING DILATATION, AN ATTEMPT WAS MADE TO ADVANCE THE WIRE AND THE BALLOON FURTHER DISTALLY WHEN THE TIP OF THE WIRE SHEARED OFF. THE DETACHED TIP WAS LEFT INSIDE THE PATIENT UP AGAINST THE VESSEL WALL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23305717 ↗
• MalfunctionFeb 6, 2023Difficult to Remove; Material Integrity Problem; Packaging Problem; Difficult to Remove; Material Integrity Problem; Packaging Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT UNDERWENT LOWER EXTREMITY RUNOFF. A 300CM V-14 CONTROL WIRE WAS REMOVED FROM THE HOOP AND USED DURING PROCEDURE. HOWEVER, THERE WAS RESISTANCE IN REMOVING THE V-14 GUIDEWIRE FROM A NON-BOSTON SCIENTIFIC CATHETER INSIDE THE VESSEL. THE PACKAGING AS WELL AS THE TIP OF THE DEVICE WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER V-14 GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308246 ↗
• MalfunctionFeb 3, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT UNDERWENT LOWER EXTREMITY RUNOFF. A 300CM V-14 CONTROL WIRE WAS REMOVED FROM THE HOOP AND USED DURING PROCEDURE. HOWEVER, THERE WAS RESISTANCE IN REMOVING THE V-14 GUIDEWIRE FROM A NON-BOSTON SCIENTIFIC CATHETER INSIDE THE VESSEL. TIP DAMAGE WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER V-14 GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294616 ↗
• MalfunctionOct 5, 2022Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON OPENING OF A 300CM LONG TAPER ANGLED TIP V-14 CONTROL WIRE GUIDEWIRE, IT WAS NOTED THAT THE TOP OF THE STERILE SLEEVE WAS DAMAGED AND SEEN TO BE NO LONGER STERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15542729 ↗
• InjuryOct 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 300CM ANGLED TIP V-14 CONTROL WIRE WAS USED DURING VASCULAR PROCEDURE. HOWEVER, IT WAS NOTICED THAT THE GUIDEWIRE FRACTURED. THE DEVICE WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH A .014 WIRE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665590 ↗
• MalfunctionDec 4, 2019Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20NOV2019. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 300CM ANGLED TIP V-14 CONTROL WIRE GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE TIP OF THE WIRE WAS FRAYED. THE PROCEDURE WS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER RETURNED ANALYSIS REVEALED DETACHED COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412002 ↗
• InjuryOct 15, 2019Detachment 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 THE ANTERIOR TIBIAL ARTERY . A 300CM V-14 CONTROL WIRE WAS ADVANCED INTO THE TARGET LESION. HOWEVER, THE TIP BROKE OFF AND THE PHYSICIAN ADDED AN HOUR OF WORK TIME TO RETRIEVE THE DETACHED TIP USING A SNARING DEVICE. CATHETERIZATION WAS CONTINUED USING A DIFFERENT WIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MODERATELY CALCIFIED WITH APPROXIMATELY 80% STENOSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195155 ↗