GLIDEWIRE UWS1035Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04987350755575), received between Dec 17, 2019 and Jan 8, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryJan 8, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE OLYMPUS GUIDEWIRE BROKE INSIDE THE PATIENT, AND THEY WERE ABLE TO RETRIEVE IT. ADDITIONAL INFORMATION WAS RECEIVED ON 06OCT2023: THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO HARM TO THE PATIENT, AND THE PATIENT WAS IN STABLE CONDITION. THERE WAS NOT PATIENT IMPACT DUE TO THE ISSUE. THE DOCTOR WAS ABLE TO REMOVE WITHOUT DIFFICULTY AS HE COULD VISUALIZE THE BROKEN FRAGMENT AND REMOVED IT EASILY. THE PROCEDURE BEING PERFORMED WAS A CYSTOSCOPY AND FLEXIBLE URETERAL PYELOSCOPY PROCEDURE. THE WIRE WAS RETRIEVED FROM URINARY TRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464053 ↗
• InjuryOct 19, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE GUIDEWIRE BROKE INSIDE THE PATIENT, AND THEY WERE ABLE TO RETRIEVE IT. ADDITIONAL INFORMATION WAS RECEIVED ON 06OCT2023: THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO HARM TO THE PATIENT, AND THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO PATIENT IMPACT DUE TO THE ISSUE. THE DOCTOR WAS ABLE TO REMOVE WITHOUT DIFFICULTY AS HE COULD VISUALIZE THE BROKEN FRAGMENT AND REMOVED IT EASILY. THE PROCEDURE BEING PERFORMED WAS A CYSTOSCOPY AND FLEXIBLE URETERAL PYELOSCOPY PROCEDURE. THE WIRE WAS RETRIEVED FROM URINARY TRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967019 ↗
• MalfunctionNov 17, 2022Peeled/Delaminated; Peeled/Delaminated

  THE DISTRIBUTOR REPORTED THAT THERE WAS A POSSIBLE OUT OF BOX (OOB) FAILURE WITH THE GUIDEWIRE INVOLVED. IT WAS REPORTED THAT THE COATING CAME OFF THE GUIDEWIRE AND WAS NOTED TO BE IN THE PATIENT. THERE WAS NO DEATH OR INJURY INCLUDING INFECTION. IT IS NOT LIKELY THAT THE MALFUNCTION OF THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO A DEATH OR INJURY. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT CONDITION IS UNKNOWN. THE PROCEDURE OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 23 AUG 2022: THE PROCEDURE PERFORMED WAS A CYSTO-UROSCOPY. THERE WAS A POSSIBLE KIDNEY STONE WITH LASER.

  Patient problems: Insufficient Information

  MAUDE report 15820117 ↗
• InjuryDec 17, 2019Material Separation; Material Separation

  PER FDA MEDWATCH REPORT # MW5090191. THE EVENT DESCRIPTION STATES: "A FEMALE WITH A HISTORY OF RIGHT FLANK PAIN DUE TO RIGHT URETEROPELVIC JUNCTION OBSTRUCTION. THE PATIENT SCHEDULED FOR ELECTIVE ROBOTIC RIGHT PYELOPLASTY SECONDARY TO RIGHT URETEROPELVIC JUNCTION OBSTRUCTION. PRIOR TO THE END OF THE SURGICAL CASE, A FLUOROSCOPIC GUIDANCE KUB WAS COMPLETED. TWO STATIC IMAGES OF THE ABDOMEN/ PELVIS WERE ARCHIVED AT THE END OF THE PROCEDURE PRIOR TO THE PT LEAVING THE OPERATING ROOM. THE PT'S INTRA-OP STATIC IMAGES SHOWED A "THIN, SHORT LINEAR DENSITY PROJECTED OVER THE RIGHT LOWER QUADRANT OF THE ABDOMEN" AND COULD NOT RULE OUT THE POSSIBILITY OF A FOREIGN BODY. FOR PT SAFETY PURPOSES, IMAGES WERE SUBMITTED FOR RADIOLOGIST REVIEW AND EVALUATED FOR UNEXPECTED FINDINGS. THE SURGEON WAS NOTIFIED OF RESULTS AND ORDERED A REPEAT KUB WHICH SHOWED A "FOREIGN BODY IN THE PT'S LOWER QUADRANT ON THE RIGHT SIDE." THE SURGEON ORDERED A CT SCAN WITHOUT CONTRAST THAT CONFIRMED THE PRESENCE OF A FOREIGN BODY ADJACENT TO THE COLON ON THE RIGHT SIDE. THE FINDINGS WERE RELAYED TO SURGEON AS A CRITICAL FINDING. THE PT RETURNED TO SURGERY ON FOR A LAPAROSCOPY AND REMOVAL OF THE FOREIGN BODY. FDA SAFETY

  Patient problems: Blood Loss

  MAUDE report 9483799 ↗
• InjuryDec 17, 2019Material Separation; Material Separation

  PER FDA MEDWATCH REPORT # MW5090191. THE EVENT DESCRIPTION STATES: "A FEMALE WITH A HISTORY OF RIGHT FLANK PAIN DUE TO RIGHT URETEROPELVIC JUNCTION OBSTRUCTION. THE PATIENT SCHEDULED FOR ELECTIVE ROBOTIC RIGHT PYELOPLASTY SECONDARY TO RIGHT URETEROPELVIC JUNCTION OBSTRUCTION. PRIOR TO THE END OF THE SURGICAL CASE, A FLUOROSCOPIC GUIDANCE KUB WAS COMPLETED. TWO STATIC IMAGES OF THE ABDOMEN/ PELVIS WERE ARCHIVED AT THE END OF THE PROCEDURE PRIOR TO THE PT LEAVING THE OPERATING ROOM. THE PT'S INTRA-OP STATIC IMAGES SHOWED A "THIN, SHORT LINEAR DENSITY PROJECTED OVER THE RIGHT LOWER QUADRANT OF THE ABDOMEN" AND COULD NOT RULE OUT THE POSSIBILITY OF A FOREIGN BODY. FOR PT SAFETY PURPOSES, IMAGES WERE SUBMITTED FOR RADIOLOGIST REVIEW AND EVALUATED FOR UNEXPECTED FINDINGS. THE SURGEON WAS NOTIFIED OF RESULTS AND ORDERED A REPEAT KUB WHICH SHOWED A "FOREIGN BODY IN THE PT'S LOWER QUADRANT ON THE RIGHT SIDE." THE SURGEON ORDERED A CT SCAN WITHOUT CONTRAST THAT CONFIRMED THE PRESENCE OF A FOREIGN BODY ADJACENT TO THE COLON ON THE RIGHT SIDE. THE FINDINGS WERE RELAYED TO SURGEON AS A CRITICAL FINDING. THE PT RETURNED TO SURGERY ON FOR A LAPAROSCOPY AND REMOVAL OF THE FOREIGN BODY. FDA SAFETY

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9483784 ↗