Cook G00517Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002005174), received between Apr 20, 2017 and Sep 22, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 22, 2020Terminated

   Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.

   Z-0399-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2025Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 19JAN2026. ACCESS WAS OBTAINED IN THE RIGHT GROIN TO TARGET THE HEART. ¿SOME¿ CALCIUM WAS NOTED IN THE ILIAC ARTERY. THE WIRE WAS NOT ALTERED PRIOR TO USE, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OF THE WIRE. THE WIRE WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT. THE WIRE, WHICH UNRAVELED DURING REMOVAL, WAS REMOVED FROM THE PATIENT, AND A NEW WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23116001 ↗
• MalfunctionMay 2, 2025Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  AS REPORTED, DURING A PERCUTANEOUS CORONARY INTERVENTION OF THE RIGHT CORONARY ARTERY, VIA ACCESS IN THE RIGHT RADIAL ARTERY, A SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE ¿FRAYED¿ UPON INSERTION OF THE DEVICE. THE WIRE WAS FLUSHED IN ITS HOLDER (¿HOOP¿) AND HANDED TO THE PHYSICIAN WITH WET 4X4 GAUZE, MOISTENED WITH HEPARINIZED SALINE. THE WIRE WAS NOT ALTERED PRIOR TO USE, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OF THE WIRE. THE USER DID NOT TORQUE THE WIRE, AND THE WIRE WAS NOT MANIPULATED BACKWARDS OR REMOVED THROUGH A NEEDLE. A NEW WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952205 ↗
• MalfunctionMay 8, 2024Unraveled Material; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269955 ↗
• MalfunctionSep 2, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12415245 ↗
• MalfunctionAug 12, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312040 ↗
• MalfunctionDec 29, 2020Fracture; Defective Device; Fracture; Defective Device

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11089284 ↗
• MalfunctionOct 5, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED, THE WIRE CORE IS PROTRUDING APPROXIMATELY 8CM FROM THE TIP OF THE SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE PRIOR TO PATIENT CONTACT. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7938217 ↗
• MalfunctionSep 27, 2018Break; Product Quality Problem

  IT WAS REPORTED THAT IN MULTIPLE CASES INVOLVING THE SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE, THE J-TIP WOULD NOT REGAIN ITS SHAPE AFTER INSERTION THROUGH THE CATHETER, AND IT SEEMED AS IF THE INNER MANDRIL WAS EITHER EXTREMELY WEAK OR BREAKING INSIDE THE WIRE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7914260 ↗
• MalfunctionJan 30, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A HEART CATHERIZATION, THE SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE WAS INSERTED AND REMOVED ONCE THROUGH THE CATHETER. WHEN THE PHYSICIAN ATTEMPTED TO PERFORM A CATHETER EXCHANGE AND WAS GETTING READY TO INPUT THE WIRE GUIDE A SECOND TIME, A HAIR-LIKE FRAGMENT UNRAVELING FROM THE WIRE GUIDE WAS OBSERVED. NO PORTIONS OF THE WIRE GUIDE REMAINED INSIDE OF THE PATIENT'S ANATOMY. ANOTHER SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT THERE WAS NO CALCIUM BUILDUP PRESENT; NO RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228605 ↗
• MalfunctionApr 20, 2017Uncoiled; Uncoiled

  IT WAS REPORTED THAT DURING A CARDIAC CATHETERIZATION, "THE WIRE PULLED APART OR BECAME UNCOILED UPON REMOVAL; IT DID NOT FULLY BREAK". THE NEEDLE WAS ALREADY OUT DURING THE REMOVAL ATTEMPT. THE WIRE WAS REMOVED WITH THE CATHETER. NO INTERVENTION WAS REQUIRED AS NOTHING REMAINED INSIDE OF THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6508057 ↗