V-18™ Control Wire™ M001468480Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic coating · Class 2
All models of V-18 Control Wire (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729715566), received between Jan 6, 2021 and Jan 10, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (2 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.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device2
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND IT WAS REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT UNDERWENT COMPLEX RECANALIZATION/THROMBOLYSIS CATHETER PLACEMENT FOR A THROMBOSED LEFT LOWER EXTREMITY FEMORAL POPLITEAL. A 110CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCESS OF ACCESSING A TIGHT CHANNEL FOR PLACING A CATHETER, IT WAS NOTED THAT A PORTION OF THE WIRE'S TIP SHEARED OFF THE NEEDLE AND WAS RETAINED WITHIN A BRANCH OF THE PATIENT'S PROFUNDAL ARTERY. MINIMAL EFFECT WAS NOTED ON PATIENT'S CARE AND THE PATIENT WAS ABLE TO GET A BYPASS THE FOLLOWING DAYS UPON A PRESUMED DIFFERENT/LARGER PROFUNDAL BRANCH. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18487313 ↗MalfunctionNov 23, 2022Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH VASCULAR ACCESS FAILURE AND UNDERWENT VASCULAR ACCESS INTERVENTION THERAPY. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MILDLY TORTUOUS VESSEL. A 110CM, 8CM V-18 CONTROL WIRE GUIDEWIRE WAS ADVANCED. HOWEVER, DURING REPEATED EXPANSION, THE BALLOON AND GUIDEWIRE GOT STUCK AROUND THE HUB. THE DEVICE WAS REMOVED TOGETHER WITH THE BALLOON AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15853298 ↗MalfunctionJan 6, 2021Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A 110CM, 8CM V-18 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR A PROCEDURE IN THE RADIAL CUTANEOUS VEIN. DURING THE PROCEDURE, A BALLOON CATHETER BECAME STUCK ON THE WIRE AND COULD NOT MOVE BACK AND FORTH. THE ENTIRE GUIDEWIRE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER V-18 WIRE AND BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11127220 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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