EMERALD 502455Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705032055031), received between Jul 27, 2023 and Aug 24, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419004 ↗
• MalfunctionJan 5, 2026Fracture

  AS REPORTED, WHEN THREADING A 5F INFINITI CORDIS JUDKINS LEFT (JL) 4 CATHETER OVER A .035 260CM EMERALD J-TIP GUIDEWIRE, THE PHYSICIAN NOTICED THE GUIDEWIRE WAS KINKED AND HAD FRACTURED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE WIRE WAS NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END, AND THE GUIDEWIRE WAS NOT SHAPED DURING PREPARATION. THERE WAS NO INDICATION OF KINKING PRIOR TO INSERTION. THE GUIDEWIRE WAS USED IN A CARDIO DIAGNOSTIC VESSEL. THERE WAS NO RESISTANCE OR FRICTION OBSERVED BETWEEN THE CATHETER AND THE EMERALD GUIDEWIRE. THE DISTAL TIP OF THE GUIDEWIRE HAD FRACTURED, BUT THE FRACTURE DID NOT RESULT IN SEPARATION INTO TWO PIECES. THE PROCEDURE WAS COMPLETED USING A NEW WIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957023 ↗
• InjuryDec 5, 2025Material Frayed; Material Frayed

  AS REPORTED, THE DISTAL SECTION OF A .035-INCH 3MM 260CM TEFLON-COATED DGW GUIDEWIRE RUPTURED (FRAYED) DURING A CORONARY ANGIOGRAPHY PROCEDURE. MANUAL INTERVENTION WAS PERFORMED AS THE RIGHT RADIAL ARTERY WAS PUNCTURED AND A 6F NON-CORDIS INTRODUCER WAS INSERTED. ANOTHER DGW WAS USED TO COMPLETE THE PROCEDURE AND THAT A CONTRALATERAL APPROACH WAS PERFORMED. THE SEPARATED PIECE WAS REMOVED BY PULLING, AND THE PIECE DID NOT FULLY DETACH FROM THE GUIDEWIRE. DURING USE, SLIGHT TORTUOSITY OF THE VESSEL WAS OBSERVED, AND THE GUIDEWIRE WAS ADVANCED WITH SUPPORT FROM A CORDIS JUDKIN¿S LEFT (JL) 3.5 DIAGNOSTIC CATHETER. RESISTANCE WAS ENCOUNTERED AT THE ELBOW, PROMPTING DEVICE REMOVAL AND ANGIOGRAPHIC ASSESSMENT, WHICH REVEALED RUPTURE OF THE GUIDEWIRE AND A TEAR OF THE ARTERY. THE LEFT RADIAL ARTERY WAS THEN ACCESSED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE WIRE WAS REMOVED FROM THE DISPENSER BY ITS DISTAL FLOPPY END, AND THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). GUIDEWIRE MANIPULATION AND TORQUING WERE PERFORMED UNDER FLUOROSCOPIC GUIDANCE, AND RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL. THE DEVICE WAS USED IN HIGHLY TORTUOUS VASCULATURE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732404 ↗
• MalfunctionJun 27, 2025Peeled/Delaminated; Device Contamination with Chemical or Other Material; Peeled/Delaminated; Device Contamination with Chemical or Other Material

  AS REPORTED, THE CUSTOMER SUBMITTED IMAGES REGARDING WIRE FRAYING IN THE PACKAGING OF A .035 X 260 CM J TIP 26 EMERALD GUIDEWIRE WHERE MULTIPLE AREAS OF PROTRUDING FILAMENTS ARE SEEN. ADDITIONALLY, IRREGULAR SPACING BETWEEN COIL TURNS IS PRESENT. IT CANNOT BE CONCLUSIVELY DETERMINED FROM THE IMAGES WHETHER THE GUIDEWIRE WAS STILL SEALED WITHIN AN UNOPENED PACKAGE AT THE TIME THE CONDITION WAS OBSERVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352065 ↗
• MalfunctionSep 23, 2024Material Frayed; Peeled/Delaminated; Material Frayed; Peeled/Delaminated

  AS REPORTED, THE .035 X 260 FIXED CORE J3MM DIAGNOSTIC GUIDEWIRE CAME SPLIT OUT OF THE BODY. THE DAMAGE WAS NOTICED AFTER SHEATH PLACEMENT, WHEN THE DEVICE WAS REMOVED. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO REPORTED INJURY TO THE PATIENT. NO IMAGES ARE AVAILABLE SHOWING THE WIRE DAMAGE. THE PRODUCT WAS STORED IN THE LAB WITH THE PACKAGE HUNG UP, AND NO DAMAGE WAS NOTED TO THE PACKAGE. NO ANOMALIES WERE OBSERVED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE WIRE THROUGH THE SHEATH OR ADVANCING THROUGH THE VESSEL. THE DEVICE WAS NOT USED TO PASS A HEAVILY CALCIFIED LESION. THE VESSEL WAS NOT SPECIFIED, BUT IT WAS NOT TORTUOUS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281171 ↗
• MalfunctionJul 22, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, THE INNER PACKAGING FOR A .035 260CM J-TIP EMERALD DIAGNOSTIC GUIDEWIRE WAS FOUND DAMAGED WHEN THE PRODUCT WAS UNPACKED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS RETURNED. ADDENDUM: TWO DEVICES WERE RETURNED FOR EVALUATION. BOTH DEVICES HAVE INNER PACKAGING DAMAGE THAT COMPROMISES THE DEVICE STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19797894 ↗
• MalfunctionJul 17, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, THE INNER PACKAGING FOR A .035 260CM J-TIP EMERALD DIAGNOSTIC GUIDEWIRE WAS FOUND DAMAGED WHEN THE PRODUCT WAS UNPACKED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS RETURNED. ADDENDUM: PRODUCT EVALUATION REVEALED TWO DEVICES WERE RETURNED AND THERE IS A TORN CONDITION ON THE INNER PACKAGING COMPROMISING THEIR STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764943 ↗
• MalfunctionAug 3, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, THE PACKAGING OF A .035 FIXED-CORE J-CURVE 3MM X 260CM EMERALD GUIDEWIRE WAS DAMAGED. THERE WAS A ¿BROKEN HOLE¿ IN THE BACK OF AN INNER POUCH PACKAGING. THE INNER PACKAGE WAS NOT OPENED AND NOT RE-SHELVED. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS NOT USED IN THE PATIENT. THE CONDITION WAS NOTICED BEFORE OPENING THE PACKAGE. THE DEVICE WAS STORED NORMALLY. THE PRODUCT WAS NOT DAMAGED. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450895 ↗
• MalfunctionJul 27, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, PACKING DAMAGE WAS FOUND FOR THE 0.35 EMERALD DIAGNOSTIC GUIDEWIRE (DGW). THE ACTUAL PRODUCT WAS NOT DAMAGED. THE STERILE POUCH RECEIVED WAS OPENED/COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS FOUND WHEN THE NURSE SENT THE PRODUCT TO THE OPERATING TABLE. THE PRODUCT IS STORED IN THE STERILE CONSUMABLE ROOM. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. A VIDEO OF THE EVENT WAS PROVIDED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406821 ↗