EMERALD 502571Recalls & reported problems
Cordis US Corp. · DGW .035 MC J3MM 150CM TEF · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705032055475), received between Oct 7, 2024 and Oct 7, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
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.
InjuryOct 7, 2024Fracture; Fracture
AS REPORTED, DURING THE PROCEDURE, .035 EMERALD J3 DIAGNOSTIC GUIDE CATHETER WAS INSERTED IN THE INTRODUCER. WHILE DOCTOR WAS TRYING TO MOVE THE DEVICE INSIDE THE VESSEL, HE/SHE REALIZED THE TIP OF THE DEVICE DETACHED. HE/SHE REMOVED THE GUIDEWIRE AND SUBSTITUTED WITH A NEW ONE. THE PROCEDURE WAS COMPLETED USING ANOTHER GUIDE CATHETER. THE PROCEDURE DID NOT CAUSE ANY INJURY TO THE PATIENT. THE DEVICE WAS PREPARED ACCORDING TO THE SPECIFIED INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE TO THE DEVICE PRIOR TO USE. THERE WAS NO RESISTANCE OR FRICTION WHILE ADVANCING IT THROUGH THE VESSEL. ADDITIONALLY, NO UNUSUAL FORCE WAS NEEDED TO ADVANCE OR WITHDRAW THE CATHETER FROM THE PATIENT. THE LESION WAS NOT CALCIFIED, AND THERE WAS NO VESSEL TORTUOSITY. AN UNKNOWN GUIDEWIRE WAS USED, AND THERE WAS NO RESISTANCE WHILE ADVANCING OVER THE GUIDEWIRE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385142 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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