HiWire G30474Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00827002304741), received between Dec 5, 2014 and Sep 3, 2026 — classified as 9 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (50 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Break

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50590561 ↗
• MalfunctionMay 27, 2026Peeled/Delaminated

  IT WAS REPORTED THE JACKET IS SEPARATED IN THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE. THE ISSUE WAS FOUND BY SUPPLIER DURING REVIEW OF DEVICE RETURNED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306281 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THE DISTAL END OF HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS BROKEN PRIOR TO USE IN THE URETERAL STONE PROCEDURE. THE ISSUE WAS FOUND WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741608 ↗
• MalfunctionMar 19, 2026Break

  UPON OPENING THE DEVICE PACKAGING, IT WAS REPORTED THAT THE DISTAL END OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS OBSERVED TO BE BROKEN PRIOR TO USE IN A URETERAL STONE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640727 ↗
• MalfunctionFeb 26, 2026Peeled/Delaminated

  IT WAS REPORTED, THE COATING OF THE DISTAL END OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDEWIRE GUIDE PEELED OFF. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456157 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE BROKE PRIOR TO A URETERAL STONE REMOVAL PROCEDURE. THE ISSUE WAS FOUND WHEN THE PACKAGE WAS OPENED AND AFTER REMOVING THE GUIDEWIRE A SMALL BLACK BROKEN FRAGMENT WAS FOUND IN THE POUCH. THE GUIDEWIRE DID NOT REMOVE FROM THE HOLDER AND WAS THE COATING ACTIVATED WITH SALINE SOLUTION. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208784 ↗
• MalfunctionDec 4, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS ORIGINALLY REPORTED THAT AFTER INSERTION INTO THE PATIENT DURING A URETEROSCOPIC LITHOTOMY FOR KIDNEY STONE REMOVAL, THE USER FOUND THE TIP OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS "UNEVEN". RESISTANCE WAS FELT, "IN AND OUT". THE PROCEDURE WAS COMPLETED BY USING A NEW UNSPECIFIED WIRE GUIDE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON COMPLETION OF THE INVESTIGATION, IT WAS DETERMINED THAT THE POLYMER JACKET HAD SEPARATED FROM THE WIRE GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716972 ↗
• MalfunctionOct 10, 2025Peeled/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 23270705 ↗
• MalfunctionJun 23, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING A URETEROSCOPY LITHOTOMY WITH STONE REMOVAL PROCEDURE; THE USER ADVANCED THE SOFT ENDOSCOPE THROUGH WIRE GUIDE AND FOUND THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE COATING PEELED OFF. THE WIRE GUIDE COATING WAS ACTIVATED WITH SALINE. THERE WAS NO RESISTANCE WHEN ADVANCING THE ENDOSCOPE. A NEW GUIDEWIRE WAS REPLACED TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22309628 ↗
• InjuryMay 19, 2025Break; Break

  IT WAS REPORTED; THE PATIENT UNDERWENT A LITHOTRIPSY AND STONE REMOVAL PROCEDURE IN (B)(6) 2025. THE PATIENT HAD A LARGE, COMPLETELY "CAST STONE" AND HEAVY STONE BURDEN IN THE RIGHT KIDNEY. IN (B)(6) 2025, DURING A FOLLOW UP APPOINTMENT AT A DIFFERENT FACILITY THAN WHERE THE LITHOTRIPSY AND STONE REMOVAL PROCEDURE HAD TAKEN PLACE, A 3 -5CM LONG PIECE OF METAL WAS DISCOVERED IN THE PATIENT'S RIGHT RENAL PARENCHYMA. THE METAL PIECE IS BELIEVED TO BE FROM THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE THAT WAS USED IN THE LITHOTRIPSY AND STONE REMOVAL PROCEDURE IN (B)(6) 2025. THE FOREIGN BODY REMAINS IN THE PATIENT, NO ADDITIONAL PROCEDURE IS CURRENTLY SCHEDULED TO REMOVE THE FOREIGN BODY, NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22047692 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  IT WAS REPORTED PRIOR TO PATIENT CONTACT; THE WIRE GUIDE COATING WAS ACTIVATED PRIOR TO REMOVAL FROM THE HOLDER BY INJECTING SALINE SOLUTION AND WAITING FOR 1 MINUTE. THE USER FELT THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE LUBRICATION WAS NOT ENOUGH AND WITH BURRS. THE BURR DID NOT DAMAGE THE SURFACE OF THE WIRE GUIDE. THE USER CHANGED TO ANOTHER SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989095 ↗
• MalfunctionMar 6, 2025Material Separation; Material Separation

  DURING A URETERAL CALCULI REMOVAL PROCEDURE, IT WAS REPORTED THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE'S TIP WAS NOTED TO BE FRACTURED UPON OPENING THE PACKAGE. THE WIRE GUIDE WAS ACTIVATED WITH SALINE AND WAS REMOVED FROM THE HOLDER AFTER SALINE INJECTION AT THE HOSPITAL. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. 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. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537257 ↗
• MalfunctionNov 21, 2024Peeled/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 20745651 ↗
• MalfunctionSep 10, 2024Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  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 20185313 ↗
• MalfunctionAug 13, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: Insufficient Information

  MAUDE report 19977402 ↗
• MalfunctionJul 17, 2024Break; Break

  AS REPORTED, A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE BROKE IN THE MIDDLE, INTO TWO PIECES, WHILE REMOVING IT FROM THE WIRE GUIDE HOLDER. SOME CONTRAST AGENT AND WATER MIXTURE WAS APPLIED TO THE HOLDER TO ACTIVATE THE COATING. THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETE WITH ANOTHER WIRE GUIDE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766816 ↗
• MalfunctionJun 18, 2024Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  AS REPORTED, DURING A URETEROSCOPY, THE POLYMER JACKET OF A 'HIWIRE NITINOL HYDROPHILIC WIRE GUIDE' SEPARATED, EXPOSING THE METAL CORE OF THE WIRE GUIDE. THE SEPARATED MATERIAL WAS REMOVED USING A TRIPOD TYPE FORCEPS. ANOTHER WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559017 ↗
• MalfunctionJun 18, 2024Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  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 19558867 ↗
• MalfunctionJun 5, 2024Break; Break

  AS REPORTED, A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE'S SOFT END BROKE AFTER IT WAS INSERTED. THE SEPARATED PIECE WAS REMOVED FROM THE PATIENT'S BLADDER LUMEN WITHOUT ANY CONSEQUENCES TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468843 ↗
• MalfunctionApr 4, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, A 'HIWIRE NITINOL HYDROPHILIC WIRE GUIDE' WAS FOUND DAMAGED WHEN THE PACKAGE WAS OPENED PRIOR TO AN UNKNOWN PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A PRELIMINARY DEVICE FAILURE ANALYSIS OF THE COMPLAINT DEVICE WAS PERFORMED AND SCRAPING DAMAGE TO THE COATING OF THE WIRE GUIDE WAS NOTED, THUS PROMPTING THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042121 ↗
• MalfunctionMar 21, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955750 ↗
• MalfunctionMar 13, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS NOTED TO BE BENT PRIOR TO USE DURING A STONE REMOVAL PROCEDURE. THE WIRE GUIDE WAS REMOVED FROM THE HOLDER AFTER ACTIVATING THE COATING WITH SALINE. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. UPON RECEIPT OF THE COMPLAINT DEVICE, A PRELIMINARY DEVICE FAILURE ANALYSIS REVEALED THE WIRE GUIDE ALSO TO BE DELAMINATED PROMPTING THIS REPORT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895571 ↗
• MalfunctionJan 10, 2024Peeled/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 18485925 ↗
• MalfunctionNov 17, 2023Break; Break

  IT WAS REPORTED THAT A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS BROKEN PRIOR TO A STENT PLACEMENT PROCEDURE AND BEFORE PATIENT CONTACT. RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE DEVICE FROM HOLDER. THE GUIDEWIRE WAS RINSED WITH SALINE. A NEW SAME WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. IT WAS SAID THAT THIS OCCURRENCE PROLONGED THE PROCEDURE TIME. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160377 ↗
• MalfunctionNov 8, 2023Peeled/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 18093853 ↗