V-18™ Control Wire™ M001468500Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729070184), received between Nov 26, 2018 and Jul 28, 2025 — classified as 7 injuries, 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA ATTACHED VOLUNTARY MEDWATCH REPORT # (B)(4) THAT TIP BREAK OCCURRED. A 150 CM, 8 CM POLY TIP V-18 CONTROL GUIDE WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE WITHIN THE SURGICAL FIELD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631392 ↗
• InjuryMay 21, 2024Detachment 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 LOWER EXTREMITY. A 150CM, 8CM V-18 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE ALONG WITH A 5FR NON-BOSTON SCIENTIFIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO CROSS THE DEVICE INTO THE LESION WHEN THE TIP WAS SHEARED OFF AND LODGED IN THE SUPERIOR LEFT ILIAC ARTERY. THE TIP WAS SNARED OUT AND ALL PARTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE VESSEL WAS HEAVILY CALCIFIED. THE PATIENT WAS GIVEN 3000 UNITS OF HEPARIN PRIOR TO ATTEMPTING TO CROSS THE LESION. THE WIRE WAS FLUSHED IN THE PROTECTIVE COIL PRIOR TO INSERTION WITH 2 UNITS/ML HEPARINIZED SALINE. WHILE TRYING TO CROSS THE LESION, RESISTANCE WAS ENCOUNTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367250 ↗
• InjuryAug 30, 2022Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CLAUDICATION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 150CM, 8CM V-18 CONTROL WIRE WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE TIP OF THE WIRE BROKE OFF. THE PHYSICIAN HAD TO USE SCISSORS TO REMOVE BROKEN PART OF WIRE TIP AND PULLED THE TIP OUT OF SHEATH. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 150CM, 8CM V-18 CONTROL WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321956 ↗
• InjuryMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CRITICAL LIMB ISCHEMIA AND UNDERWENT ANGIOGRAM. THE TARGET LESION WAS LOCATED IN THE COMMON FEMORAL PATCH WITH LOTS OF SCAR TISSUE. A 150CM, 8CM V-18 CONTROL WIRE WAS USED FOR ACCESS. HOWEVER, THE TIP OF THE WIRE BROKE OFF INSIDE THE VESSEL OF THE PATIENT DURING ATTEMPTED ACCESS. THERE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 14310725 ↗
• MalfunctionMay 13, 2020Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07MAY2020. IT WAS REPORTED THAT INSERTING DIFFICULTIES WERE ENCOUNTERED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED FOREARM SHUNT. A 150CM, 8CM POLY TIP V-18 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE IN COMBINATION WITH A NON-BSC BALLOON CATHETER. HOWEVER, THE GUIDEWIRE HAD DIFFICULTY INSERTING INTO THE GUIDEWIRE LUMEN OF THE BALLOON CATHETER. BOTH DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED GUIDEWIRE COATING PEELED/SHEARED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10052460 ↗
• InjuryMar 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 150CM, 8CM POLY TIP V-18 CONTROL WIRE GUIDEWIRE WAS ADVANCED; HOWEVER, THE TIP BROKE OFF. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED COMPONENT BUT THE TIP WAS STUCK AND REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9841699 ↗
• MalfunctionFeb 19, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK ON THE WIRE. A STERLING OVER-THE-WIRE, 3.0MM X 20MM 90CM 4 FRENCH (4F) BALLOON ALONG WITH A V-18, 150CM, 8CM POLY TIP GUIDEWIRE WERE SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. DURING THE PROCEDURE, THE WIRE WAS POSITIONED IN THE PATIENT AND THE BALLOON WAS PASSED OVER THE WIRE WITH NO PROBLEM AND THE BALLOON SUCCESSFULLY INFLATED. UPON REMOVAL ATTEMPTS, WHEN THE PHYSICIAN ATTEMPTED TO SLIDE THE BALLOON BACK ALONG THE WIRE IT WOULD NOT MOVE AND WAS STUCK ON THE WIRE. THE WIRE AND BALLOON WERE REMOVED FROM THE PATIENT TOGETHER. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729332 ↗
• MalfunctionNov 21, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE WIRE COATING WAS PEELED OFF. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A150CM, 8CM V-18 CONTROL WIRE WAS USED IN A PROCEDURE. THE BALLOON AND THE WIRE WERE REMOVED FROM THE PATIENT'S BODY. HOWEVER, WHEN THE WIRE WAS REMOVED FROM THE BALLOON CATHETER OUTSIDE THE PATIENT'S BODY, THE HYDROPHILIC COATING WAS NOTED TO BE PEELED OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9354094 ↗
• MalfunctionSep 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURED. THE PROCEDURE WAS PERFORMED BY VENOUS APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED FOREARM VEIN. AFTER A 150CM, 8CM V-18 CONTROL WIRE WAS ADVANCED, PRE-DILATATION WAS PERFORMED WITH A PERIPHERAL CUTTING BALLOON. HOWEVER, AFTER INFLATION, RESISTANCE WAS ENCOUNTERED AND THE GUIDEWIRE AND BALLOON WERE THEN REMOVED FROM THE PATIENT. WHEN THE GUIDE WIRE WAS REMOVED FROM THE BALLOON, IT WAS NOTICED THAT THE COIL PART OF THE TIP WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9030235 ↗
• MalfunctionJul 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A 150CM, 8CM POLY TIP V-18 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE GOT SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE BROKE INSIDE THE PATIENT'S BODY AT A PORTION NEAR THE TIP OF THE DEVICE AND THE DEVICE WAS COMPLETELY REMOVED. THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE DETACHMENT WAS DUE TO A CALCIFIED LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8837250 ↗
• InjuryJun 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE ABDOMEN. A 150CM, 8CM V-18 CONTROL WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, WHEN TRYING TO ACCESS A 22X20CM NEEDLE, THE WIRE BROKE OFF. ANOTHER 150CM, 8CM V-18 CONTROL WIRE WAS ADVANCED BUT THE WIRE ALSO BROKE OFF. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS OKAY.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8716198 ↗
• InjuryJun 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE ABDOMEN. A 150CM, 8CM V-18 CONTROL WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, WHEN TRYING TO ACCESS A 22X20CM NEEDLE, THE WIRE BROKE OFF. ANOTHER 150CM, 8CM V-18 CONTROL WIRE WAS ADVANCED BUT THE WIRE ALSO BROKE OFF. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS OKAY.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8716194 ↗
• MalfunctionApr 22, 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 A ILIAC/FEMORALIS ARTERY. A 150CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. HOWEVER, DURING WITHRAWAL, THE TIP OF THE GUIDEWIRE BROKE AND FELL OFF INSIDE THE CATHETER. THE DEVICE WAS REMOVED SAFELY. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8536846 ↗
• MalfunctionApr 11, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 150CM X 8CM POLY TIP V-18 CONTROL WIRE WAS USED TOGETHER WITH A RUBICON SUPPORT CATHETER. THE WIRE WAS USED TO PROBE THE VESSEL OCCLUSION. HOWEVER, UPON PULLING THE WIRE BACK INTO THE END OF THE RUBICON, THE PHYSICIAN NOTICED THAT THE COATING OF THE TIP OF THE WIRE WAS HANGING OFF. THE PHYSICIAN WAS ABLE TO PULL THE WIRE AND THE HANGING PIECE BACK INTO THE RUBICON. THE WIRE WAS THEN REPLACED WITH A VICTORY WIRE AND THE SAME RUBICON WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8504120 ↗
• InjuryNov 26, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDE WIRE COATING SHEARED OFF AND THE PROFUNDA WAS PUNCTURED. THE TARGET LESION WAS LOCATED IN THE PROFUNDA FEMORIS ARTERY. A NON-BSC MICROPUNCTURE KIT WAS USED TO ACCESS THE ARTERY. THEN A 150CM, 8CM V-18 CONTROL WIRE WAS ADVANCED THROUGH THE MICROPUNCTURE KIT. HOWEVER, WHILE REPOSITIONING THE WIRE, THE HYDROPHILIC COATING OF THE WIRE SHEARED OFF IN THE VESSEL. SNARING ATTEMPTS WERE MADE BUT THEY WERE UNSUCCESSFUL. THEREFORE THE FRAGMENTS WERE LEFT INSIDE OF THE PATIENT AND THE PROCEDURE WAS STOPPED. IT WAS ALSO REPORTED THAT THE PROFUNDA WAS PUNCTURED DURING THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 8102051 ↗