EMERALD 502585Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032055598), received between Jul 7, 2024 and Sep 23, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Material Frayed; Peeled/Delaminated; Material Frayed; Peeled/Delaminated

  AS REPORTED, THE COATING OF THE .035 FIXED CORE J3MM 175CM DIAGNOSTIC EMERALD GUIDEWIRE WAS CUT AT THE END. A FRAGMENT OF WIRE WAS EMERGING FROM THE COATING AT THE END OF THE DEVICE. IT WAS NOTED THAT THE WIRE INSIDE THE GUIDEWIRE/COATING WAS CUT. THE PHYSICIAN FELT FRICTION WHILE ENTERING THE GUIDEWIRE INTO THE DIAGNOSTIC CATHETER, WHICH LED HIM TO REFRAIN FROM PUSHING THE GUIDEWIRE FURTHER INTO THE PATIENT. INSTEAD, HE REMOVED IT AND USED A NEW WIRE OF THE SAME CATALOG. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED ON A SHELF IN ITS BOX, AND NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DAMAGE WAS NOTICED WHEN THE GUIDEWIRE WAS FIRST INSERTED INTO THE DIAGNOSTIC CATHETER AT THE BEGINNING OF THE PROCEDURE. THE DEVICE IS BEING RETURNED FOR EVALUATION. IT IS CONFIRMED THAT THE DEVICE WAS NOT USED TO ATTEMPT PASSING A HEAVILY CALCIFIED LESION, AND DETAILS REGARDING THE LESION¿S LOCATION AND VESSEL TORTUOSITY ARE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION. THERE ARE NO IMAGES AVAILABLE TO SHOW THE WIRE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20282158 ↗
• InjuryJul 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT FELL INTO ANAPHYLACTIC SHOCK DURING A CARDIAC PROCEDURE WITH THE USE OF A 0.035IN FIXED-CORE J- CURVE 3MM X 175CM EMERALD DIAGNOSTIC GUIDEWIRE, THREE 5F JUDKIN'S LEFT (JL) 4 100CM INFINITI DIAGNOSTIC CATHETER, AND A 5.2F JUDKIN'S RIGHT (JR) 4 125CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THE PRODUCT WAS INSPECTED BEFORE USE AND APPEARED TO BE NORMAL. NO INFORMATION WAS PROVIDED REGARDING THE ACTIONS PERFORMED ON THE GUIDEWIRE TO PREPARE IT FOR USE, BUT NO SPECIAL PROBLEMS WERE DETECTED DURING THE PREPARATION. THE GUIDEWIRE WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS REMOVED EASILY AND INTACT FROM THE PATIENT. THE CARDIAC PROCEDURE WAS COMPLETED SUCCESSFULLY AT (B)(6) IN GENEVA. THE PATIENT'S CONDITION IS COMPLETELY STABLE, AND THEY HAVE BEEN AT HOME FOR SEVERAL MONTHS. HOWEVER, THE PATIENT WILL NEED TO UNDERGO A NEW PROCEDURE IN THE COMING WEEKS. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE USED MONTHS AGO, AND THE DEVICES ARE NO LONGER AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686018 ↗