EMERALD 502521Recalls & reported problems
Cordis Corporation · DGW .035 FC J3MM 150CM TEF · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705032055116), received between Feb 17, 2022 and Aug 14, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Peeled/Delaminated3
- Device Contamination with Chemical or Other Material2
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254441 ↗MalfunctionFeb 18, 2025Peeled/Delaminated; Peeled/Delaminated
THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397420 ↗MalfunctionApr 19, 2024Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, A .035 150CM EMERALD GUIDEWIRE BROKE DURING USE, EXPOSING SHARP EDGE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19145586 ↗MalfunctionSep 26, 2023Fracture; Fracture
AS REPORTED, THE TIP OF A J-TIP EMERALD 150CM GUIDEWIRE WAS FRACTURED AND ABOUT TO BREAK. A NEW UNKNOWN DIAGNOSTIC GUIDEWIRE WAS PROVIDED AND THE PROCEDURE COMPLETED. THE FRACTURE WAS FOUND WHILE PREPARING THE ITEMS FOR THE PUNCTURE OF THE RIGHT RADIAL ARTERY. THERE WAS NO REPORTED PATIENT INJURY. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17817543 ↗MalfunctionJun 14, 2023Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material
AS REPORTED, THE .035 J-CURVE DIAGNOSTIC GUIDEWIRE DEVICE WAS OPENED. THE DOCTOR PREPARES TO PASS THE GUIDE THROUGH THE INTRODUCER WHEN HE OBSERVES A FOREIGN BODY COMING OUT OF THE GUIDEWIRE. THE REASON FOR WHICH IT IS NOT POSSIBLE TO PASS THE GUIDE, WE PROCEED TO MAKE THE CHANGE OF THE INPUT IN THE ROOM TO BE USED. THE PACKAGING OF THE DEVICE WAS DAMAGED. THE STERILITY OF THE DEVICE WAS COMPROMISED PRIOR TO OPENING. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DIFFICULTY REMOVING THE WIRE FROM THE PACKAGING. EXTRA FORCE WAS NOT NEEDED TO REMOVE THE DEVICE. THE DEVICE WILL NOT BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17126346 ↗MalfunctionMay 9, 2023Fracture; Fracture
AS REPORTED, TWO STANDARD .035 X 150CM J TIP EMERALD DIAGNOSTIC GUIDEWIRES WERE FOUND TO HAVE FRACTURES PROXIMAL TO THE J TIP WHEN REMOVING FROM THE CATHETER. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16896380 ↗MalfunctionMay 9, 2023Fracture; Fracture
AS REPORTED, TWO STANDARD .035 X 150CM J TIP EMERALD DIAGNOSTIC GUIDEWIRES WERE FOUND TO HAVE FRACTURES PROXIMAL TO THE J TIP WHEN REMOVING FROM THE CATHETER. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16896219 ↗MalfunctionFeb 17, 2022Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, THE TIP OF THE .035 FC J3MM 150CM TEF DIAGNOSTIC GUIDEWIRE WAS DEFORMED OUT OF THE BOX AND BEFORE THE PACKAGE WAS OPEN. THE BOX WAS STORED PER THE INSTRUCTIONS FOR USE (IFU) AND OPENED UNDER STERILE PROCEDURE. A BLURRED IMAGE OF A J TIP WIRE WAS RECEIVED FOR EVALUATION. IT APPEARS AS IF THE COATING ON THE DISTAL PORTION OF THE WIRE HAS FRACTURED AND REMAINS ON THE CORE WIRE. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE PROCEDURE COMPLETED BY OPENING A SECOND WIRE FROM THE SAME BOX. THE PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13549630 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.