V-14™ Control Wire™ H74939216718210Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729799207), received between Oct 19, 2018 and Jun 30, 2025 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM BECAME STUCK ON THE GUIDEWIRE. A V-14 CONTROL WIRE WAS SELECTED FOR USE. A CAROTID WALLSTENT WAS ADVANCED OVER THE V-14 WITHOUT ISSUE. AFTER THE WALLSTENT WAS SUCCESSFULLY DEPLOYED, THE PHYSICIAN WENT TO WITHDRAW THE STENT DELIVERY SYSTEM. THERE WAS DIFFICULTY WITHDRAWING, AND THE DELIVERY SYSTEM BECAME STUCK ON THE V-14. THE GUIDEWIRE AND DELIVERY SYSTEM WERE REMOVED AS ONE UNIT. OUTSIDE OF THE PATIENT, THE GUIDEWIRE AND DELIVERY SYSTEM WERE ABLE TO BE SEPARATED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365871 ↗
• MalfunctionApr 30, 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 A DEVICE COMPONENT DETACHED AND BECAME STUCK INSIDE OF THE PATIENT. A V-14? CONTROL WIRE? WAS SELECTED FOR A PROCEDURE. DURING THIS EVENT, A DEVICE COMPONENT DETACHED AND BECAME STUCK INSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21933885 ↗
• MalfunctionApr 4, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME ENTRAPPED ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER AND A 182CM V-14 CONTROL WIRE WERE SELECTED FOR USE. THE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON GOT STUCK WHEN ADVANCING INTO THE GUIDEWIRE. SO PHYSICIAN DECIDED TO REMOVE THE BALLOON AND THE GUIDEWIRE, BUT THE GUIDEWIRE GETS TRAPPED INSIDE THE BALLOON AND THE BALLOON WAS COMPLETELY DAMAGED WHEN ATTEMPTING TO SEPARATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996254 ↗
• InjuryAug 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT UNDERWENT PEDAL STICK TO DO A RETROGRADE TIBIAL VESSEL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED TIBIAL VESSEL. TWO 182CM STRAIGHT TIP V-14 CONTROL WIRE WERE SELECTED FOR USE. HOWEVER, UPON TRYING TO CROSS THE CHRONIC TOTALLY OCCLUDED LESION, THE TIP OF BOTH GUIDEWIRES WERE FRACTURED. THE PHYSICIAN USED A TIBIAL BALLOON TO CAPTURE THE FRACTURED PIECES AND COMPLETELY REMOVED IT. NOTHING WAS LEFT BEHIND AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389019 ↗
• InjuryAug 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT UNDERWENT PEDAL STICK TO DO A RETROGRADE TIBIAL VESSEL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED TIBIAL VESSEL. TWO 182CM STRAIGHT TIP V-14 CONTROL WIRE WERE SELECTED FOR USE. HOWEVER, UPON TRYING TO CROSS THE CHRONIC TOTALLY OCCLUDED LESION, THE TIP OF BOTH GUIDEWIRES WERE FRACTURED. THE PHYSICIAN USED A TIBIAL BALLOON TO CAPTURE THE FRACTURED PIECES AND COMPLETELY REMOVED IT. NOTHING WAS LEFT BEHIND AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389006 ↗
• InjuryJun 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED AND REMAINED INSIDE THE PATIENT. A V-14 CONTROL WIRE WAS SELECTED FOR USE IN A PULMONARY BALLOON ANGIOPLASTY PROCEDURE TO TREAT STENOSIS IN A LUNG VESSEL. DURING THE PROCEDURE, WHILE DILATING THE LUNG VESSEL AS USUAL, 1MM OF THE TIP COATING DETACHED. THE DEVICE FRAGMENT WAS NOT REMOVED AND REMAINED IN THE LUNG WITHOUT ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12054233 ↗
• MalfunctionFeb 17, 2021Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 182CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, THE WIRE SNAPPED IN HALF WHILE PULLING THE WIRE OUT OF THE HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER V14 GUIDEWIRE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340256 ↗
• MalfunctionJul 10, 2019Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED FROM THE RIGHT GROIN. THE TARGET LESION WAS LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. AFTER A 6FR NON-BSC SHEATH WAS PLACED, A 182CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS USED TO CROSS THE LESION. HOWEVER, WHEN A NON-BSC INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ALSO ADVANCED TO THE LEFT ILIAC, THE GUIDEWIRE BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776477 ↗
• InjuryApr 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DETACHMENT OF DEVICE OCCURRED. THE TARGET LESION WAS LOCATED IN AM ARTERIOVENOUS (AV) FISTULA. A 182CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE UPON REMOVAL, THE TIP BECAME DETACHED/STRIPPED. PART OF THE GUIDEWIRE REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8492549 ↗
• InjuryOct 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 182CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS ADVANCED BUT DURING PROCEDURE THE TIP OF THE DEVICE GOT DETACHED IN THE TIBIOPERONEAL TRUNK. THE PHYSICIAN TRIED TO REMOVED THE DETACHED COMPONENT BUT DID NOT SUCCEED. THE PROCEDURE ENDED WELL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7984022 ↗