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SUREGLIDE 41BXRecalls & reported problems

Gyrus ACMI, LLC · SUREGLIDE Guidewire 0.035" (0.89mm) x 150cm Stiff Body, 3cm Straight Tip (5/PK) · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925005433), received between Aug 4, 2023 and Aug 4, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    OLYMPUS RECEIVED A MEDWATCH REPORT (B)(4) INDICATING THAT THE WIRE COATING OF THE 0.035" SUREGLIDE STIFF, BX/5 GUIDEWIRE DISLODGED INSIDE THE PATIENT'S KIDNEY UPON REMOVAL DURING A CYSTOURETEROSCOPY WITH HOLMIUM LASER LITHOTRIPSY OF URETERAL CALCULUS AND STENT INSERTION. THE PROVIDER WAS ABLE TO EXTRACT THE WIRE COATING. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17460753 ↗

Other STYLET, URETERAL devices

All STYLET, URETERAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.