HiWire G30473Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002304734), received between Apr 25, 2018 and Sep 29, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Peeled/Delaminated; Peeled/Delaminated

  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 15508448 ↗
• MalfunctionJul 7, 2020Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10238790 ↗
• MalfunctionApr 6, 2020Peeled/Delaminated; Peeled/Delaminated

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928065 ↗
• MalfunctionApr 1, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, DURING FLEXIBLE LASER URETEROLITHOTRIPSY, WHEN INSERTING A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE THROUGH THE WORKING CHANNEL OF THE RIGID URETEROSCOPE, THE HYDROPHILIC COVER IS COMING OFF. A DIFFERENT TYPE HYDROPHILIC WIRE GUIDE WAS USED TO PROCEED WITH THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909742 ↗
• MalfunctionOct 29, 2019Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  ADDITIONAL INFORMATION WAS RECEIVED 05NOV2019: NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249652 ↗
• MalfunctionOct 29, 2019Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  ADDITIONAL INFORMATION WAS RECEIVED 05NOV2019: NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249465 ↗
• MalfunctionOct 3, 2019Material Separation; Material Separation

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 03OCT2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152541 ↗
• MalfunctionJan 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY , USING A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE ALONG WITH A DISPOSABLE TWO-PART TROCAR NEEDLE TO REMOVE A 3CM RENAL STONE, THE TEFLON PORTION OF THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE SHEARED OFF. THE SHEARING OCCURRED DURING REMOVAL OF THE HIWIRE NITINOL HYDROPHILIC WIRE-GUIDE THROUGH THE NEEDLE WHERE RESISTANCE WAS FELT. THE PORTION THAT SHEARED OFF WAS REMOVED WITHIN THE SHEATH AND THE PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS ALLEGED MALFUNCTION. ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT HAS BEEN REQUESTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8218678 ↗
• MalfunctionNov 5, 2018Break; Break

  IT WAS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE, WHILE INTRODUCING THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE THROUGH THE NEEDLE CANNULA, THE HIWIRE CUT OFF FAR FROM THE DISTAL TIP. A SECOND HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS OPENED AND THEY EXPERIENCED THE SAME ISSUE WITH THAT DEVICE. THEY OBSERVED THAT THE TIP OF THE WIRE GUIDE HAD BEEN CUT OFF PRIOR TO PATIENT CONTACT. A THIRD HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PROCEDURE WAS PROLONGED 25-30 MINUTES, WHICH DID NOT HAVE ANY IMPACT ON THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038711 ↗
• MalfunctionNov 5, 2018Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  IT WAS REPORTED, DURING A CYSTOSCOPY WITH STENT PLACEMENT, THE COATING OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE STRIPPED OFF AND CAUSED THE WIRE TO GET STUCK ON AN IMPACTED STONE. THE COATING ON THE WIRE BUNCHED UP ON THE WIRE, EXPOSING THE WIRE CORE. LASER LITHOTRIPSY WAS REQUIRED DUE TO THE WIRE GETTING STUCK IN THE PATIENT. THE DOCTOR LASERED A CHANNEL THROUGH THE STONE TO RELEASE THE WIRE. THE LITHOTRIPSY WAS PERFORMED UNEXPECTEDLY, BUT WAS NOT CONDUCTED IN A SEPARATE PROCEDURE, BUT RATHER AS A CONTINUATION OF THE CYSTOSCOPY/STENT PLACEMENT PROCEDURE. AS REPORTED, THE PATIENT HAD PRESENTED WITH AN INFECTION PRIOR TO THE PROCEDURE. THIS WAS KNOWN TO THE TREATING PHYSICIAN, WHICH IS WHY THE PHYSICIAN WAS PLACING A STENT, WITH PLANS TO BRING THE PATIENT BACK AT A LATER TIME FOR TREATMENT OF THE STONE. THE STENT WAS PLACED AND ANY MEDICATIONS GIVEN ARE UNKNOWN. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038671 ↗
• MalfunctionMay 22, 2018Cut In Material; Cut In Material

  IT WAS REPORTED THAT THE DOCTOR WAS USING A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE AND NEEDLE FROM UROTECH GMBH DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL). THE DOCTOR NOTICED THAT THE WIRE TIP HAD BEEN SLIT WHILE IT WAS USED TO ACCESS THOUGH THE NEEDLE CANNULA. THE DOCTOR THEN EXCHANGED THE DEVICE FOR A NEW HI-WIRE GUIDE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.  ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7532829 ↗
• MalfunctionApr 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT WHILE USING A TWO PART TROCAR NEEDLE AS A CANNULA FOR THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE, THE WIRE GUIDE WAS LEFT INSIDE OF THE PATIENT'S RIGHT KIDNEY, APPROXIMATELY 10CM DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL). THE UROLOGIST REMOVED THE WIRE BY USING AN AMPLATZ INTRODUCER. THE USER ALSO STATED THAT THE TWO PART TROCAR NEEDLE WAS NOT SMOOTH ON THE INNER SIDE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7459135 ↗