OLYMPUS GWH3505RARecalls & reported problems
Gyrus ACMI, LLC · UltraTrack Hybrid Guidewire 0.035" (0.89mm) x 150cm Regular Body, 5cm Angled Tip (5/PK) · Class 1
All models of Olympus (27)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821925031432), received between Jan 18, 2021 and Jun 14, 2023 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Flaked” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Flaked4
- Device Fell1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2023Flaked; Flaked
THE CUSTOMER REPORTED TO OLYMPUS THE 0.035" ANGLED TIP, HYBRID GUIDEWIRE HAD BLACK FLAKES COMING OFF WHILE INSIDE THE PATIENT DURING USE. THE ISSUE OCCURRED DURING AN UNIDENTIFIED, DIAGNOSTIC PROCEDURE WHICH WAS COMPLETED WITH ANOTHER GUIDEWIRE. THE PROCEDURE HAD TO BE EXTENDED BY 10 MINUTES WHILE THE BLACK FLAKES WERE RETRIEVED FROM INSIDE THE PATIENT, BUT THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT DUE TO THE DELAY. RELATED PATIENT IDENTIFIER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17131815 ↗InjuryJun 14, 2023Flaked; Flaked
THE CUSTOMER REPORTED TO OLYMPUS THE 0.035" ANGLED TIP, HYBRID GUIDEWIRE HAD BLACK FLAKES COMING OFF WHILE INSIDE THE PATIENT DURING USE. THE ISSUE OCCURRED DURING AN UNIDENTIFIED, DIAGNOSTIC PROCEDURE WHICH WAS COMPLETED WITH ANOTHER GUIDEWIRE. THE PROCEDURE HAD TO BE EXTENDED BY 10 MINUTES WHILE THE BLACK FLAKES WERE RETRIEVED FROM INSIDE THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT DUE TO THE DELAY. RELATED PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17131807 ↗InjuryJun 14, 2023Flaked; Flaked
THE CUSTOMER REPORTED TO OLYMPUS THE 0.035" ANGLED TIP, HYBRID GUIDEWIRE HAD BLACK FLAKES COMING OFF WHILE INSIDE THE PATIENT DURING USE. THE ISSUE OCCURRED DURING AN UNIDENTIFIED, DIAGNOSTIC PROCEDURE WHICH WAS COMPLETED WITH ANOTHER GUIDEWIRE. THE PROCEDURE HAD TO BE EXTENDED BY 10 MINUTES WHILE THE BLACK FLAKES WERE RETRIEVED FROM INSIDE THE PATIENT, BUT THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT DUE TO THE DELAY. RELATED PATIENT IDENTIFIER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17131801 ↗InjuryJun 14, 2023Flaked; Flaked
THE CUSTOMER REPORTED TO OLYMPUS THE 0.035" ANGLED TIP, HYBRID GUIDEWIRE HAD BLACK FLAKES COMING OFF WHILE INSIDE THE PATIENT DURING USE. THE ISSUE OCCURRED DURING AN UNIDENTIFIED, DIAGNOSTIC PROCEDURE WHICH WAS COMPLETED WITH ANOTHER GUIDEWIRE. THE PROCEDURE HAD TO BE EXTENDED BY 10 MINUTES WHILE THE BLACK FLAKES WERE RETRIEVED FROM INSIDE THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT DUE TO THE DELAY. RELATED PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17131795 ↗MalfunctionJan 18, 2021Device Fell; Device Fell
IT WAS REPORTED THAT DURING A THERAPEUTIC PROCEDURE PART OF THE TIP COATING OF THE DEVICE PEELED OFF AND FELL INTO THE RENAL PELVIS OF THE PATIENT. THE PIECES THAT FELL OFF WERE ABLE TO BE RETRIEVED USING FORCEPS. THE INTENDED PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR INJURY REPORTED. THERE WAS NO USER INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11189489 ↗
Other STYLET, URETERAL devices
- ZIPwire™ M0066802220Lake Region Medical · Stylet, Ureteral46 reports
- ZIPwire™ M006630222B0Lake Region Medical · Stylet, Ureteral21 reports
- OLYMPUS GWH3505RGyrus ACMI, LLC · STYLET, URETERAL16 reports
- ZIPwire™ M006630205B0Lake Region Medical · Stylet, Ureteral10 reports
- ZIPwire™ M0066802050Lake Region Medical · Stylet, Ureteral9 reports
- ZIPwire™ M0066802080Lake Region Medical · Stylet, Ureteral9 reports
- ZIPwire™ M006630209B0Lake Region Medical · Stylet, Ureteral5 reports
- OLYMPUS GWH3805RGyrus ACMI, LLC · STYLET, URETERAL4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page