AGILITY 614-482Recalls & reported problems
Cerenovus, Inc. · AGILITY 14 STEERABLE GUIDEWIRES Guidewire Dia. .014 Inch (.36mm) Usable Length 205cm 20cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Soft Contents: 1 guidewire, 1 torquing device and 1 introducer. · Class 2
Data updated Oct 16, 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 10886704029069), received between Feb 5, 2021 and Feb 5, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture1
- Malposition of Device1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2021Fracture; Stretched; Malposition of Device; Fracture; Stretched; Malposition of Device
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH THE TARGET AT THE RIGHT TRANSVERSE VENOUS DOMINANT SINUS WITHOUT ANY ANATOMICAL VARIATIONS, THE 0.014IN. X 205CM AGILITY 14 SOFT STEERABLE GUIDEWIRE (614482 / LOT# UNKNOWN) WAS FLUSHED, PREPARED, AND SHAPED GENTLY. HEPARINIZED SALINE FLUSH (PRESSURE) WAS USE WITH A CLOSE SYSTEM CREATED BY THE ROTATING HEMOSTASIS VALVE (RHV). THE DEVICE WAS USED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE INTACT WIRE WAS INTRODUCED ATRAUMATICALLY INTO THE CONCOMITANT EXCELSIOR XT-27 MICROCATHETER (STRYKER) USING THE INTRODUCER PROVIDED. THE WIRE WOULD NOT TORQUE IN THE PATIENTS VEIN. IT WAS TAKEN OUT AND THERE IS AN UNRAVELING AT THE TIP OF THE WIRE APPROXIMATELY 1.5CM FROM THE DISTAL END. THE WIRE WAS REMOVED FROM THE PATIENT WITHOUT ANY ADDITIONAL INTERVENTION, THERE WAS NO FRAGMENT IN THE PATIENT. THERE WAS NO HARM TO THE PATIENT BUT THERE IS THE RISK THAT THE WIRE COULD HAVE COMPLETELY FRACTURED AND EMBOLIZED IN THE PATIENTS BODY. IT WAS REPORTED THAT FORCE WAS NOT APPLIED DURING THE HANDLING OF THE WIRE; THE CAUSE OF HOW IT BECAME UNRAVELED IS NOT KNOWN. A DIFFERENT WIRE WAS USED WITH THE SAME CONCOMITA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11286609 ↗
Other GUIDE, WIRE, CATHETER, NEUROVASCULATURE devices
- Synchro SELECT SSTD215STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall97 reports
- Synchro SELECT SSTD215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall16 reports
- Synchro SELECT SSUP215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall11 reports
- Synchro2 S2SPS14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall1 death6 reports
- Synchro SELECT SSUP300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall5 reports
- Synchro2 S2SPP14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall2 reports
- Synchro SELECT SSFT300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall0 reports
- Mirage 103-0608Micro Therapeutics, Inc. · Guide, wire, catheter, neurovasculature12 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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