HiWire G30470Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002304703), received between Aug 23, 2018 and Oct 23, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20516220 ↗
• InjuryJul 20, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, THE PHYSICIAN WAS MET WITH RESISTANCE WHEN ATTEMPTING TO ADVANCE A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE THROUGH A NEEDLE SEMI-RIGID URETEROSCOPE WHILE GAINING ACCESS TO THE URETER. THE PATIENT HAD RADIATION PRIOR TO THE PROCEDURE, AND THEY GAINED ACCESS BY WIRING IT UP THROUGH THE KIDNEY. THE PATIENT WAS NOTED TO HAVE SCARRED ANATOMY. A CATHETER WAS PLACED OVER THE WIRE, AND IT WAS FOUND THAT THE WIRE HAD SHEARED OFF. THE PHYSICIAN BELIEVES THEY REMOVED ALL OF THE WIRE (DEVICE USED UNKNOWN). A SECOND WIRE KINKED AND BEGAN TO SEPARATE, BUT IT DID NOT SHEAR. IT IS POSSIBLE THAT THE SCOPE OR ANGLE COULD HAVE CONTRIBUTED TO THE ISSUES. A SMALLER DIAMETER WIRE WORKED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE. DEVICES WERE RETURNED ON (B)(6) 2022: ATTACHED PHOTO'S SHOW COATING SEPARATION ON BOTH WIRE GUIDES. FOR THE FIRST WIRE GUIDE THE COATING SEPARATED AND CAME COMPLETELY OFF THE WIRE. FOR THE 2ND DEVICE THE COATING SEPARATED, BUT DID NOT COMPLETELY COME OFF THE WIRE. KINKED WIRE WAS N

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064204 ↗
• MalfunctionAug 23, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TEFLON ON THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE SPLIT/PEELED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7809360 ↗