HiWire G30475Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002304758), received between Jan 3, 2020 and Oct 20, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (5 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.

• MalfunctionOct 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE, THE COATING SEPARATED FROM THE INNER CORE AT THE DISTAL END OF THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE. THE USER REMOVED THE DEVICE FROM THE INTACT PACKAGE AND OBSERVED THE COATING AT THE DISTAL END OF THE WIRE GUIDE WAS DAMAGED. PER PROVIDED IMAGE, THE COATING WAS OBSERVED TO BE SEPARATED FROM THE INNER CORE OF THE WIRE GUIDE. 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 23335894 ↗
• MalfunctionAug 18, 2025Peeled/Delaminated; Peeled/Delaminated

  AS ORIGINALLY REPORTED, THE USER CONFIRMED THAT THE PACKAGE OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE DEVICE WAS INTACT BEFORE OPENING IT. THE DEVICE WAS REMOVED FROM THE PACKAGE AND SUBMERGED IN STERILE SALINE TO ACTIVATE THE COATING. DURING THE UNSPECIFIED PROCEDURE, THE WIRE GUIDE WAS REMOVED FROM ITS HOLDER AND WAS OBSERVED TO HAVE AN UNEVEN TWISTED APPEARANCE. THE USER REPLACED THE WIRE GUIDE WITH A NEW ONE TO CONTINUE THE PROCEDURE. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE WAS RETURNED TO COOK FOR INVESTIGATION ON 01JUN2025. THE DEVICE WAS THEN SENT TO THE SUPPLIER FOR A SUPPLIER INVESTIGATION. ACCORDING TO THE SUPPLIER INVESTIGATION ON 24JUL2025, THE POLYMER JACKET OF THE WIRE GUIDE HAD SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833890 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  IT WAS REPORTED, DURING THE SUPPLIER INVESTIGATION OF A BENT HIWIRE NITINOL HYDROPHILIC WIRE GUIDE, IT WAS FOUND THAT THE POLYMER JACKET OF THE WIRE GUIDE WAS CUT/DAMAGED, EXPOSING THE METALLIC CORE WIRE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399573 ↗
• InjuryJan 20, 2025Material 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 21191347 ↗
• MalfunctionDec 11, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE COATING OF THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS DELAMINATED DURING DEVICE FAILURE ANALYSIS (DFA) CONDUCTED FOR ANOTHER FAILURE MODE FOR THE SAME DEVICE. THE TIP OF THE PRODUCT PROTECTOR (PP) WAS BENT DURING AN UNKNOWN PROCEDURE, WHICH WAS THE INITIAL COMPLAINT. AFTER LUBRICATING THE PP, THE WIRE WAS EASILY REMOVED AND EXAMINED. IT WAS FOUND THAT THE BLACK PLASTIC COATING WAS SCRAPED OFF AT APPROXIMATELY 31.5 CM FROM THE PROTRUDING TIP, SUGGESTING THAT THE WIRE MIGHT HAVE BEEN PULLED BEFORE LUBRICATION, CAUSING THE BEND AND SCRAPING. THE PROCEDURE WAS COMPLETED USING ANOTHER HIWIRE. AS REPORTED, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES 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 20906451 ↗
• MalfunctionOct 25, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, THE DOCTOR OPENED THE STERILE PACKAGE AND TOOK OUT THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE BEFORE AN UNKNOWN PROCEDURE AND FOUND THE HYDROPHILIC COATING WAS PEELED OFF AND THE DISTAL END OF THE WIRE GUIDE CANNOT FORM 1:1 TORQUE. THE DEVICE WAS NOT USED. THE HYDROPHILIC COATING OF THE WIRE GUIDE HAD NOT YET BEEN ACTIVATED. THE GUIDEWIRE WAS REPLACED WITH A NEW SAME-LIKE DEVICE. A PHOTO OF THE COMPLAINT DEVICE SHOWS WHAT APPEARS TO BE THE JACKET OF THE WIRE GUIDE HAS SEPARATED. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. 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 20538192 ↗
• MalfunctionMar 25, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, UPON OPENING THE PACKAGING OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE, THE COATING WAS DAMAGED APPROXIMATELY 5 CENTIMETERS ALONG THE DEVICE. A PHOTO PROVIDED SHOWS THE COATING PEELED/SEPARATED FROM THE WIRE IN SEVERAL LOCATIONS. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904986 ↗
• MalfunctionJan 3, 2020Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE USING A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE, THE USER EXPERIENCED RESISTANCE WHEN ATTEMPTING TO ADVANCE THE WIRE GUIDE. WHEN THE WIRE GUIDE WAS WITHDRAWN, IT WAS NOTED THAT THE "COVERING PEELS OF THE WIRE GUIDE WAS BROKEN". THE USER CHANGED TO ANOTHER SAME TYPE DEVICE TO COMPLETE SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 9544656 ↗