Victory ™ Victory 18 (300 cm, 30g)Recalls & reported problems
Brivant Limited · Victory ™ - 00816349012426 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816349012426), received between Aug 16, 2022 and Aug 16, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2022Break; Break
MD WAS ATTEMPTING TO CROSS A HEAVILY CALCIFIED LESION FROM THE PEDAL APPROACH. DURING THE ATTEMPT TO CROSS, THE DISTAL TIP OF THE WIRE BROKE OFF WITHIN THE CTO. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NONE. WHAT IS THE NEXT COURSE OF ACTION?: LEAVE THE TIP IN THE BODY AS NO WAY TO SNARE THE TIP. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: OTHER IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: YES. PLEASE DESCRIBE THE WAY IN WHICH THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION?: THE TIP OF THE WIRE BROKE OFF IN THE PATIENTS LEG. MEDICAL OR SURGICAL INTERVENTIONS: NONE. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: NO PATIENT OUTCOME: UNKNOWN. REASON FOR UNSUCCESSFUL PROCEDURE: THE TIP OF THE WIRE WAS LEFT IN THE BODY AND THE MD WAS UNABLE TO CROSS THE CTO. WAS THE PATIENT SEDATED WHEN THE PROCEDURE WAS CANCELLED?: YES - LOCAL ANESTHESIA.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15232809 ↗
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- 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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