V-14 Control WireRecalls & reported problems across all models
Boston Scientific Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 195
- Deaths reported
- 0
- Injuries reported
- 100
- Recalls
- 0
We found 7 models of V-14 Control Wire by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 195 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2018 and Aug 5, 2026 — classified as 100 injuries, 95 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (119 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
Reports received per month, all models
Most reported V-14 Control Wire problems
Device problems
- Detachment of Device or Device Component119
- Material Integrity Problem38
- Fracture24
- Entrapment of Device22
- Difficult to Remove18
- Adverse Event Without Identified Device or Use Problem17
- Difficult to Advance10
- Material Deformation9
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- Foreign Body In Patient45
- No Consequences Or Impact To Patient40
- Device Embedded In Tissue or Plaque26
- No Known Impact Or Consequence To Patient7
- No Code Available4
- Insufficient Information3
- Obstruction/Occlusion2
V-14 Control Wire models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- V-14™ Control Wire™ H74939216730010WIRE, GUIDE, CATHETER111 reports
- V-14™ Control Wire™ H74939216730020WIRE, GUIDE, CATHETER35 reports
- V-14™ Control Wire™ H74939216930010WIRE, GUIDE, CATHETER29 reports
- V-14™ Control Wire™ H74939216718210WIRE, GUIDE, CATHETER10 reports
- V-14™ Control Wire™ H74939216930020WIRE, GUIDE, CATHETER7 reports
- V-14™ Control Wire™ H74939216918210WIRE, GUIDE, CATHETER2 reports
- V-14™ Control Wire™ H74939216918220WIRE, GUIDE, CATHETER1 report
Recent V-14 Control Wire adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 5, 2026Detachment of Device or Device Component
It was reported that the guidewire tip detached. A V-14? Control Wire? Short Taper Straight Tip 300cm guidewire was selected for use in a right leg angioplasty procedure. During the procedure, the proximal half of the guidewire tip broke off inside the patient. The guidewire fragment could not be retrieved. There were no further complications reported.
Patient problems: Foreign Body In Patient
MAUDE report 50140991 ↗MalfunctionApr 3, 2026Entrapment of Device; Fracture; Failure to Advance; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE WIRE BECAME STUCK AND BEGAN TO SEPARATE. A V-14? CONTROL WIRE? WAS SELECTED FOR USE IN THE PLAIN OLD BALLOON ANGIOPLASTY (POBA) PROCEDURE. THE TARGET LESION WAS LOCATED IN THE 90% STENOSED ANTERIOR TIBIAL ARTERY, AND WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. DURING THE PROCEDURE, WHILE CROSSING THE LESION, THE WIRE BECAME STUCK WITHIN THE PATIENT ANATOMY. THE WIRE WAS REMOVED FROM THE PATIENT IN ONE PIECE. UPON REMOVAL, IT WAS OBSERVED THAT THE TIP OF THE WIRE HAD BEGUN TO PEEL. THE WIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778920 ↗MalfunctionFeb 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT WIRE DETACHED OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY LESION. A V-14? CONTROL WIRE? GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE WIRE DETACHED. THE WIRE WAS REMOVED AND A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24262099 ↗MalfunctionJan 5, 2026Entrapment of Device
IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A 2.5MM X 60MM X 150CM COYOTE BALLOON CATHETER AND 300CM V-14 CONTROL WIRE GUIDEWIRE WERE SELECTED FOR TIBIAL ANGIOPLASTY. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE AND BALLOON HAD BECOME FUSED DURING THE PROCEDURE, REQUIRING BOTH DEVICES TO BE PULLED AND REMOVED AS A SINGLE UNIT. THE BALLOON WAS REMOVED IN A FULLY DEFLATED STATE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23959931 ↗InjuryNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT AND VESSEL OCCLUSION OCCURRED, AND THE PROCEDURE WAS CANCELLED. DURING THE INTERVENTION, A V-14 SHORT TAPER 300 CM STRAIGHT TIP WIRE WAS USED IN AN ATTEMPT TO CROSS THE CHRONIC TOTAL OCCLUSION (CTO) OF THE ANTERIOR TIBIAL ARTERY. WHILE ADVANCING THROUGH A COLLATERAL VESSEL, THE WIRE TIP FRACTURED AND REMAINED WITHIN THE VESSEL, RESULTING IN PARTIAL OCCLUSION OF THE COLLATERAL. THROMBOSIS WAS ALSO NOTED. AFTER EVALUATION, THE PHYSICIAN ELECTED TO DISCONTINUE ATTEMPTS TO CROSS THE ANTERIOR TIBIAL CTO. THE RETAINED WIRE TIP WAS LEFT IN PLACE, AS IT WAS ASSESSED TO POSE NO SIGNIFICANT CLINICAL RISK. THE ANTERIOR TIBIAL BRANCH REMAINED OCCLUDED, CONSISTENT WITH AN INFLOW/OUTFLOW ISSUE. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. THE PATIENTS ANATOMY WAS CONSIDERED CHALLENGING, AND PATIENT-RELATED FACTORS CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, NO PROCEDURAL FACTORS WERE IDENTIFIED AS CONTRIBUTING. THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING THE PROCEDURE.
Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 23659949 ↗InjuryNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE WIRE BROKE OFF WITHIN THE ARTERY, REQUIRING ADDITIONAL INTERVENTION. DURING A LOWER EXTREMITY (LE) ANGIOGRAM, THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL (PT) ARTERY. A LONG TAPER 300 CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE. WHILE CROSSING THE LESION, THE TIP OF THE GUIDEWIRE FRACTURED AND BROKE OFF WITHIN THE PT ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SEPARATED TIP USING A SNARE DEVICE; HOWEVER, RETRIEVAL EFFORTS WERE UNSUCCESSFUL DUE TO THE SEVERITY OF THE VESSEL CALCIFICATION. THE FRACTURED TIP REMAINED WITHIN THE ARTERY, AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE PATIENT CONDITION WAS GOOD FOLLOWING PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 23604614 ↗InjuryNov 12, 2025Fracture; Fracture
IT WAS REPORTED THAT TIP BREAK OCCURRED, REQUIRING AN ADDITIONAL DEVICE. A 300CM V-14? CONTROL WIRE? WAS SELECTED FOR USE DURING A BELOW THE KNEE ANGIOPLASTY PROCEDURE. THE TARGET LESION WAS GREATER THAN 90% STENOSED, WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE WHILE REMOVING THE DEVICE FROM THE BODY POST ANGIOPLASTY. IT WAS NOTED THAT THE DEVICE WAS OUTSIDE THE BODY AT THE TIME OF THE FRACTURE, AND IT WAS ALSO NOTED THAT THE DEVICE WAS REMOVED INTACT WITH THE HELP OF A DIAGNOSTIC CATHETER. A NEW V-14 CONTROL WIRE WAS USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ONLY THE TIP OF THE WIRE BROKE. WHEN THE PHYSICIAN RETRACTED THE DAMAGED V-14 WIRE WITH THE HELP OF A CATHETER, SHE WAS ABLE TO VISUALIZE THE EXTENT OF THE DAMAGE. ADVANCING THE BALLOON OVER THE DAMAGED WIRE WAS DIFFICULT AND IT DID NOT PROVIDE ADEQUATE SUPPORT, SO THE WIRE WAS REMOVED AND REPLACED WITH A NEW ONE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENTS BODY WITH THE ASSISTANCE OF A DIAGNOSTIC CATHETER. THE TIP WAS OBSERVED TO BE DETACHED UPON REMOVAL OF THE DIAGNOSTIC CATHETER IN THE STERILE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536255 ↗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 ↗MalfunctionOct 2, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE HYDROPHILIC COATING WAS MISSING FROM THE GUIDEWIRE. A V-14 CONTROL WIRE WAS SELECTED FOR USE IN BALLOON ANGIOPLASTY PROCEDURE IN THE TIBIAL ARTERY. IT WAS INSERTED THROUGH A MICROPUNCTURE KIT AND NON-BSC SUPPORT CATHETER INTO THE PEDAL ARTERY. WHEN THE V-14 CONTROL WIRE WAS REMOVED, IT WAS OBSERVED THAT THE HYDROPHILIC COATING WAS MISSING FROM THE GUIDEWIRE. SUBSEQUENT FLUOROSCOPIC PICTURES WERE TAKEN, AND IN WHICH NO PART OF THE GUIDEWIRE WAS FOUND (IN-SITU). THE SURGEON WAS NOT CONCERNED, AND NO FURTHER PROCEDURES WILL BE UNDERTAKEN DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23203189 ↗MalfunctionSep 25, 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 THE GUIDEWIRE TIP BROKE. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL VESSEL. A 300CM STRAIGHT TIP V-14? CONTROL WIRE? WAS SELECTED FOR USE. DURING THE PROCEDURE WHILE CROSSING THE LESION, THE HYDROPHILIC TIP DETACHED AND REMAINED IN A SMALL BRANCH OF THE ANTERIOR TIBIAL VESSEL. THE REST OF THE DEVICE WAS REMOVED FROM THE BODY. THE PHYSICIAN ELECTED TO LEAVE THE TIP IN PLACE, CONSIDERING THE RISK MINIMAL AND THE BRANCH SMALL ENOUGH. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. NO ADVERSE EFFECTS WERE OBSERVED FROM LEAVING THE TIP BEHIND. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 23145193 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR USE IN A LOWER EXTREMITY ANGIOGRAM. WHILE CROSSING A STENT IN THE THROMBOSED SFA, THE TIP OF THE V-14 CONTROL WIRE BECAME STUCK IN THE STRUTS OF THE STENT. WHEN ATTEMPTING TO REMOVE THE WIRE, APPROXIMATELY 2CM OF THE TIP OF THE WIRE FRACTURED AND THE FRAGMENT APPEARED TO BE LODGED IN THE STENT BETWEEN THE ARTERIAL WALL AND THE STENT. NO FRAGMENT RETRIEVAL WAS ATTEMPTED FOR THE REMAINDER OF THE CASE AS THE PHYSICIAN DID NOT SEE ANY INHERENT DANGER OF THE WIRE PARTICLE EMBOLIZING DISTALLY AND THERE WAS NO PLAN TO REMOVE THE DETACHED FRAGMENT IN THE NEAR FUTURE. AN ANGIOPLASTY OF THE AREA WHERE THE TIP FRAGMENT WAS LODGED WAS PERFORMED AS PART OF THE STANDARD PROTOCOL TO TREAT THE LESION. THE PROCEDURE WAS COMPLETED WITH THE USE OF OTHER DEVICES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 23056562 ↗MalfunctionSep 11, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE GUIDEWIRE COATING WAS PEELED OFF. THE OVER 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE COATING WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026372 ↗MalfunctionSep 10, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE GUIDEWIRE COATING WAS PEELED OFF. THE OVER 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE COATING WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018326 ↗MalfunctionAug 29, 2025Fracture; Failure to Advance; Fracture; Failure to Advance
IT WAS REPORTED THAT THE DEVICE LOST THE DISTAL TIP COATING. VASCULAR ACCESS WAS GAINED VIA IPSILATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE NEARLY OCCLUDED LEFT PERONEAL ARTERY. A 300CM V-14 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE IN A AN ANGIOPLASTY PROCEDURE. AN ATTEMPT TO CROSS THE LESION WAS MADE; HOWEVER THE GUIDEWIRE FAILED TO CROSS THE LESION. THE GUIDEWIRE WAS REMOVED FROM THE PATIENT. A FLUOROSCOPY IMAGE SHOWED A PIECE OF THE WIRE COATING WAS STILL IN THE PATIENTS VESSEL, ADJACENT TO THE OCCLUSION. IT WAS NOT POSSIBLE TO RETRIEVE THE PIECE OF THE WIRE COATING. THE PHYSICIAN WAS HAPPY TO CONCLUDE THE CASE AT THIS POINT AS THE PIECE OF WIRE DEBRIS COULD NOT MOVE PAST THE OCCLUDED PORTION OF THE VESSEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS NO ATTEMPT TO REMOVE THE PIECE OF WIRE COATING FROM THE PATIENT AND THERE ARE NO PLANS TO TRY AND RETRIEVE IT.
Patient problems: Foreign Body In Patient
MAUDE report 22922569 ↗InjuryAug 11, 2025Detachment 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 DISTAL ANTERIOR TIBIAL ARTERY. A 300CM V-14 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL TIP OF THE WIRE DETACHED AND ABOUT 1CM LENGTH WAS LEFT BEHIND IN THE PATIENT'S LEFT TIBIAL ARTERY. THE WIRE TIP WAS ATTEMPTED TO SNARE HOWEVER, IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE.
Patient problems: Foreign Body In Patient
MAUDE report 22778244 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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