AGILITY 614-178Recalls & reported problems
Cerenovus, Inc. · AGILITY 10 STEERABLE GUIDEWIRES Guidewire Dia. .010 Inch (.25mm) Usable Length 195cm 10cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Standard Contents: 1 guidewire, 1 torquing device and 1 introducer. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704029038), received between Jun 15, 2022 and Jun 15, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation1
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.
InjuryJun 15, 2022Material Separation; Material Separation
IT WAS REPORTED BY A CONSUMER THAT A PATIENT UNDERWENT EMBOLIZATION OF A SPINAL DURAL ARTERIOVENOUS MALFORMATION (AVM) USING A 195 CM AGILITY .010 GUIDEWIRE (PRODUCT CODE: 614178, LOT UNKNOWN), WHICH FRACTURED DURING THE PROCEDURE AND WAS LEFT INSIDE THE PATIENT. THE WIRE WAS TRACKED OUT IN VERY TORTUOUS ANATOMY AND WHILE THE CATHETER WAS ADVANCED THE WIRE FRACTURED. THE SURGERY WAS DELAYED FOR MORE THAN 60 MINUTES. THE GUIDEWIRE WAS NOT ABLE TO BE REMOVED USING A SNARE, BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND THEY WERE NOT EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. PER THE EVENT DESCRIPTION, THE PATIENT EXPERIENCED UNSPECIFIED CONSEQUENCES, BUT THERE WAS NO CLINICAL OUTCOME EXPERIENCED BY THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14696327 ↗
Other GUIDE, WIRE, CATHETER, NEUROVASCULATURE devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.