HiWire G30476Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002304765), received between Dec 15, 2017 and Aug 12, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781945 ↗
• InjurySep 18, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS DIFFICULT TO REMOVE FROM A DISPOSABLE TWO-PART TROCAR NEEDLE. THE WIRE GUIDE WAS PLACED UNDER X-RAY THROUGH THE SHEATH OF THE TROCAR NEEDLE DURING A LEFT SUPINE PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE FOR AN UNKNOWN PATIENT. ACCESS TO THE KIDNEY WAS ACHIEVED, AND THE INNER TROCAR OF THE NEEDLE WAS REMOVED BEFORE PLACING THE WIRE GUIDE THROUGH THE OUTER SHEATH OF THE NEEDLE. NO RESISTANCE WAS REPORTED. THE WIRE WAS MANIPULATED IN ORDER TO PLACE THE WIRE DOWN THE URETER; HOWEVER, IN THIS PROCESS THE WIRE WOULD NOT MOVE ANY MORE. ATTEMPTED WITHDRAW OF THE WIRE GUIDE WAS UNSUCCESSFUL. THEREFORE, THEY ATTEMPTED TO PULL THE WIRE THROUGH VIA A RETROGRADE APPROACH USING ANOTHER MANUFACTURER'S DISPOSABLE URETEROSCOPE AND A COOK FLEXOR URETERAL ACCESS SHEATH. FURTHER ATTEMPTS TO WITHDRAW THE WIRE VIA A NEEDLE SHEATH REVEALED THE COATING HAD BEEN STRIPPED FROM THE WIRE LEAVING A BARE WIRE SECTION. DILATION WAS CONTINUED WITH FASCIAL DILATOR SETS FOLLOWED BY A NEPHROSTOMY BALLOON CATHETER. A DUAL LUMEN URETERAL ACCESS CATHETER WAS USED TO EXCHANGE THE WIRE FOR A NEW WIRE GUIDE. WHEN THE NEEDLE AND SHEATH WERE PUT BACK TOGETHER ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770512 ↗
• MalfunctionAug 11, 2023Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED 14SEP2023: THE COATING OF THE WIRE GUIDE WAS ACTIVATED WITH STERILE WATER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514655 ↗
• InjuryMar 22, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A PCNL PROCEDURE, THE COATING OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS SHAVED OFF. THE DEVICE WAS NOT INSPECTED BEFORE USE. THE COATING WAS ACTIVATED FOR 30 MINUTES; THE WIRE WAS KEPT HYDRATED THROUGHOUT THE PROCEDURE. THE COATING WAS SHAVED OFF WHILE ATTEMPTING TO GAIN DIFFICULT ACCESS WHEN THE USER ADVANCED AND RETRACTED THE WIRE THROUGH A CHIBA BIOPSY NEEDLE. THE DEVICE WAS PUT THROUGH THE NEEDLE THREE TIMES AS THEY ATTEMPTED TO GAIN ACCESS IN THE KIDNEY. AFTER THE THIRD TIME, IT WAS NOTICED THAT THE INTEGRITY ON THE WIRE HAD BEEN COMPROMISED. THE DEVICE WAS REMOVED. THE USER RETRIEVED THE SHAVED PORTION OF THE COATING WITH A GRASPER THROUGH A NEPHROSCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 16592705 ↗
• InjuryJul 27, 2021Material 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

  MAUDE report 12234173 ↗
• MalfunctionJan 6, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 10JAN2020: THE PROCEDURE BEING PERFORMED WAS URETEROSCOPY AND RETROGRADE INTRARENAL SURGERY (RIRS). THE WIRE GUIDE PEELED DURING REMOVAL OF THE WIRE GUIDE THROUGH THE WORKING CHANNEL OF THE URETEROSCOPE. THE SMALL PIECES OF THE WIRE GUIDE COVERING WERE REMOVED WITH AN EXTRACTOR. THE DURATION OF PROCEDURE WAS EXTENDED BY APPROXIMATELY 60 MINUTES. THERE WERE NO PROBLEMS WITH THE PATIENT AND NO PIECES OF THE WIRE GUIDE WERE LEFT INSIDE THE URINARY TRACT OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553526 ↗
• InjuryFeb 27, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE, FOLLOWING NEEDLE ACCESS, THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS PUT THROUGH THE NEEDLE CANNULA. THE WIRE EITHER WAS SHEARED OR KNOTTED WHEN ATTEMPTS WERE MADE TO GET DOWN THE URETER. THE DOCTOR ALSO USED A 5FR OPEN ENDED CATHETER TO ATTEMPT TO CHANGE OUT THE WIRE WITH A DIFFERENT VERSION. ULTIMATELY, THEY HAD TO CUT THE WIRE TO GET IT OUT. NO VISIBLE PIECE WAS LEFT AND IT IS BELIEVED THAT ALL THE WIRE WAS RETRIEVED. INABILITY TO GET KIDNEY ACCESS LED TO URETEROSCOPY WITH LASER. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT RESULTING FROM THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7299067 ↗
• InjuryDec 15, 2017Material Separation; Material Separation

  THE USER FACILITY REPORTED DURING A PORT-A-CATH INSERTION PROCEDURE, THE COATING OF THE WIRE CAME OFF INSIDE OF THE PATIENT. THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY TO REMOVE THE COATING; HOWEVER THE COATING REMAINS INSIDE OF THE PATIENT AS THEY WERE NOT ABLE TO REMOVE IT. THE PATIENT OUTCOME AFTER THIS EVENT HAS BEEN REQUESTED; HOWEVER, AT THIS TIME IT IS UNKNOWN IF THE PATIENT HAD ANY ADVERSE EFFECTS RELATED TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7123607 ↗