Victory ™ Victory 14 (300 cm, 30g)Recalls & reported problems
Brivant Limited · Victory ™ - 00816349012402 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816349012402), received between Oct 4, 2023 and Oct 21, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
HEAVILY CALCIFIED CTO OF POP. TRIED FROM ABOVE AND BELOW. WHILE TRYING TO STAY TRUE LUMEN AND STRUGGLING TO FIND ANY CALCIUM CHANNELS THE PHYSICIAN ASKED FOR A 12-GRAM TIP VICTORY .18 WIRE. WHILE TRYING TO WIRE THE CTO THE TIP OF THE WIRE BECAME DISCONNECTED FROM THE BODY OF THE WIRE. HE THEN ASKED FOR ANOTHER WIRE THIS TIME A 30-GRAM TIP VICTORY .30 WIRE WITH THE SAME OUTCOME, WITH THE WIRE TIP BREAKING OFF AND EMBEDDING IN THE CALCIUM. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED SUCCESSFULLY. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? WIRE WAS REMOVED. WHAT IS THE NEXT COURSE OF ACTION? SECOND WIRE WAS REMOVED. WAS PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493736 ↗MalfunctionOct 4, 2023Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. AFTER INSERTING A 30G VICTORY 14 GUIDEWIRE, AN OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, AFTER THE CATHETER WAS PLACED ACROSS THE LESION AND THE DEVICE WAS TURNED ON, THE CATHETER TWISTED UPON ITSELF IMMEDIATELY, AND NO IMAGES WERE OBTAINED. THE DEVICES WERE THEN REMOVED TOGETHER AS THEY WERE INSEPARABLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT WIRE AND A DIFFERENT IMAGING CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17872771 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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