Cook G14544Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002145443), received between May 24, 2016 and May 30, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED, WHEN OPENING THE PACKAGE OF A STANDARD FIXED CORE WIRE GUIDE IT WAS FOUND TO BE BROKEN, "IT LOOKS LIKE IT CAME UNRAVELED". THE PROCEDURE WAS COMPLETED WITH A NEW WIRE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118051 ↗
• MalfunctionApr 10, 2018Detachment Of Device Component; Component Missing; Structural Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE FIXED CORE WIRE GUIDE WAS NOT COMPLETE. IT WAS FURTHER NOTED THAT THE WELD ON FLEXIBLE TIP OF THE WIRE GUIDE WAS MISSING AND THE INNER WIRE WAS DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7413066 ↗
• MalfunctionJan 24, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE PLASTIC COVERING ON A STANDARD FIXED CORE WIRE GUIDE BECAME DISLODGED DURING THE PROCEDURE AND THE INTERNAL COIL WIRE BEGAN TO UNRAVEL AND STRETCH ON EXTRACTION OF THE STENT. THE PROCEDURE WAS CONDUCTED UNDER IMAGE INTENSIFIER. THE PATIENT WAS WELL SCREENED AGAIN AFTER SHREDDING OBSERVED VIA INSPECTION USING IMAGE INTENSIFIER. THE SURGEON CONFIRMS NO FOREIGN BODY LEFT INSITU, AS EVIDENCED VIA IMAGE INTENSIFIER. NO METAL OR PLASTIC IDENTIFIED (ALSO NO OPACITY WAS NOTED VIA IMAGE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7214958 ↗
• MalfunctionSep 16, 2016Break; Break

  DURING A STEPTOSTOCOMY WITH STENT PROCEDURE (REPLACING URETEROSCOPY STENT), THE WIRE BROKE WHEN PLACING THE URETERAL STENT. THE WIRE WAS RUN UP THE URETER AND THE STENT WAS RUN UP THE WIRE FOR PLACEMENT. WHEN AN ATTEMPT WAS MADE TO REMOVE THE WIRE, IT BEGAN TO STRIP. THE WIRE AND STENT HAD TO BE REMOVED TOGETHER IN ORDER TO GET IT OUT OF THE PATIENT. ANOTHER WIRE WAS OPENED AND THE STENT WAS REPLACED. THE CASE WAS COMPLETED WITHOUT THE PATIENT EXPERIENCING ANY ADDITIONAL ADVERSE EVENTS. THE PATIENT¿S CONDITION WAS UNKNOWN. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5956357 ↗
• InjuryMay 24, 2016Material Separation; Material Separation

  DURING A URETER STONE LITHO PROCEDURE ON THE FEMALE PATIENT, THE WIRE TIP BROKE AND WAS RETRIEVED WITH A BASKET. THE LASER TECH STATED THE DOCTOR'S LASER HIT IT, RESULTING IN THE BREAKAGE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 5675283 ↗