EMERALD 502581Recalls & reported problems
Cordis US Corp. · DGW .035 MC STR 150CM TEF · 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 10705032055550), received between Dec 14, 2022 and Dec 14, 2022 — 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
- Material Frayed1
- Material Split, Cut or Torn1
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.
MalfunctionDec 14, 2022Fracture; Material Frayed; Material Split, Cut or Torn; Fracture; Material Frayed; Material Split, Cut or Torn
AS REPORTED, DURING THE USE OF A .035 EMERALD MOVABLE-CORE PTFE-COATED STRAIGHT TIP150CM DIAGNOSTIC GUIDEWIRE THE TIP PARTIALLY BROKE WHEN REMOVED. THE DEVICE WAS VISUALLY INSPECTED AND THE TIP WAS PARTIALLY DETACHED (DIDN'T DETACH COMPLETELY) AND IT WAS FRAYED. THE WIRE DID NOT BECOME FIXED OR CAUGHT AT ANY TIME IT WAS ONLY WHEN REMOVED DID THE PHYSICIAN REALIZED THERE WAS A STRANGE CURVE. THE PHYSICIAN ASSURES NO EXTRA FORCE WAS APPLIED DURING USE. THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE PROCEDURE WAS CARRIED OUT WITH A DIFFERENT NON-CORDIS GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE WIRE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS NOT RE-SHAPED BY THE USER NOR USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THERE WAS NO DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL OR LESION. THE WIRE WAS NOT TORQUED AGAINST RESISTANCE AND THE WIRE BEHAVE ¿NORMALLY.¿ THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15983537 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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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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