HiWire G36282Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002362826), received between Jul 18, 2016 and Dec 16, 2022 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionDec 16, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, UPON OPENING A HIWIRE HYDROPHILIC WIRE GUIDE'S PACKAGE, THE USER NOTED A SMALL WHITE SECTION ON THE WIRE; HOWEVER, THE DEVICE WAS STILL USED. THE WIRE WAS ADVANCED BUT RESISTANCE WAS ENCOUNTERED AT THE WHITE SECTION. THE WIRE WAS REMOVED AND A KINK WAS NOTED AT THE WHITE SECTION. ANOTHER WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THAT A SECTION OF THE WIRE'S OUTER COATING APPEARS TO BE MISSING OR SEPARATED FROM THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997268 ↗
• MalfunctionOct 4, 2019Material Deformation; Material Deformation

  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 9156733 ↗
• MalfunctionAug 2, 2019Material Perforation; Material Perforation

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

  Patient problems: Pain

  MAUDE report 8855199 ↗
• MalfunctionSep 19, 2018Break; Physical Resistance/Sticking

  THE COMPLAINANT REPORTED THAT ANOTHER MANUFACTURER'S BALLOON WAS LOADED ONTO THE HIWIRE HYDROPHILIC WIRE GUIDE WHILE WORKING IN A FISTULA. THE BALLOON WOULD NOT COME OFF OF THE WIRE AS A RESULT OF THE WIRE BECOMING ¿TACKY.¿ THE BALLOON AND THE WIRE WERE REMOVED AT THE SAME TIME, AND WIRE ACCESS WAS LOST. IT WAS FURTHER NOTED THAT A SECTION OF THE BLACK POLYMER MATERIAL WAS PARTIALLY SHEARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE AFTER GAINING ACCESS AGAIN, AND THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889467 ↗
• MalfunctionSep 18, 2018Peeled/Delaminated

  IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, IT WAS NOTED THAT THERE WAS A DEFECT ON THE TIP OF THE HYDROPHILIC WIRE GUIDE. IT WAS OBSERVED THAT THERE WAS PEELING OF THE POLYMER JACKET ABOUT 25 CM FROM THE TIP OF THE WIRE GUIDE. ANOTHER DEVICE WAS USED, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885485 ↗
• InjurySep 27, 2017Material Fragmentation; Material Fragmentation

  A HIWIRE HYDROPHILIC WIRE GUIDE WAS USED IN A PERCUTANEOUS TRANSHEPATIC CHOLANGIAL DRAINAGE (PTCD) PROCEDURE. IT WAS REPORTED THAT, AN INDWELLING NEEDLE, CONTAINED IN ANOTHER MANUFACTURER'S PTCD SET, WAS PUNCTURED FROM THE BRANCH OF RIGHT BILE DUCT. THE HIWIRE WIRE GUIDE WAS ADVANCED THROUGH THE NEEDLE TO THE TARGET LESION AND THE PROCEDURE WAS CONTINUED. THEN, SO AS TO CHANGE THE WIRE GUIDE TO ANOTHER ONE, THE PHYSICIAN WITHDREW THE COMPLAINT WIRE GUIDE OUT OF THE BODY, BUT RESISTANCE WAS ENCOUNTERED AT THAT TIME. HE CHECKED IT AND FOUND THAT THE COATING OF THE WIRE GUIDE HAD BEEN PEELED OFF. THE PEELING STARTED AT THE PART APPROXIMATELY 15 CM DISTAL FROM THE PROXIMAL END OF THE WIRE GUIDE, AND EXTENDED PROXIMALLY TO THE AREA NEAR THE PROXIMAL END OF IT. SOME PIECES OF THE PEELED FRAGMENTS REMAINED IN THE PATIENT'S BODY AT THAT TIME. THE PROCEDURE CONTINUED AND A PTCD TUBE WAS PLACED IN THE PATIENT WITH THE EXCHANGED WIRE GUIDE AND THE PROCEDURE WAS COMPLETED. THE PTCD TUBE WAS RETRIEVED OUT OF THE BODY. THE PIECES OF THE PEELED COATING REMAINING IN THE BODY WERE ALSO RETRIEVED OUT OF THE BODY AT THE SAME TIME AS THE TUBE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6896940 ↗
• InjuryNov 10, 2016Material Separation; Material Separation

  A MALE WITH HISTORY OF PROSTATE CANCER AND PROSTATECTOMY HAD DEEP VEIN THROMBOSIS (DVT) OF THE LEFT LOWER EXTREMITY. SURGEON HAD ATTEMPTED INSERTION OF INFERIOR VENA CAVA (IVC) FILTER WITH VENOGRAM. SINCE THE LEFT ILIAC VEIN WAS CLOTTED, IT WAS DECIDED TO GO ON THE RIGHT SIDE. SURGEON WAS ABLE TO CANNULATE THE VEIN, BUT COULD NOT PASS THE WIRE. SO, THEREFORE, THE ULTRASOUND MACHINE WAS USED AND IT WAS NOTED THAT THE VEIN WAS POSTERIOR TO THE ARTERY. IR RECOMMENDED JUGULAR APPROACH. THEN, THE RIGHT INTERNAL JUGULAR WAS TAPPED, THROUGH WHICH A WIRE WAS PASSED. HOWEVER, THE SURGEON COULD NOT PASS THE WIRE TOO FAR BELOW THE DIAPHRAGM, AND THE WIRE MET RESISTANCE. THEREFORE, A VENOGRAM WAS DONE AND THIS SHOWED THERE WAS COMPETE OCCLUSION OF THE IVC ABOUT 3 INCHES BELOW THE DIAPHRAGM WITH COLLATERAL FORMATION. BECAUSE OF THAT, THE SHEATH WAS REMOVED FROM THE NECK AND PRESSURE WAS APPLIED TO THE PUNCTURE SITE. THE PROCEDURE WAS TERMINATED AND THE PATIENT WAS SENT HOME. THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT (ED) LATER WITH C/O BILATERAL LEG PAIN AND SWELLING. CTA OF CHEST SHOWED A LINEAR METALLIC FOREIGN BODY WITHIN THE RIGHT COMMON FEMORAL VEIN. APPROX. 1CM. SURGEON FELT RETAIN

  Patient problems: Foreign Body In Patient

  MAUDE report 6092939 ↗
• InjuryJul 18, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT AN (B)(6) YEAR OLD PATIENT UNDERWENT ABDOMINAL DRAINAGE TO TREAT INTRA-ABDOMINAL ABSCESSES. THE PHYSICIAN PUNCTURED THE PATIENT'S ABDOMINAL AREA WITH THE METALIC NEEDLE AND THE STENT WAS INSERTED INTO THE NEEDLE. WHEN THE PHYSICIAN REMOVED THE WIRE GUIDE, THE OUTER MATERIAL OF THE WIRE GUIDE GOT STUCK WITH THE POINTED AREA OF THE NEEDLE AND CAME OFF. THE OUTER PART OF THE MATERIAL REMAINED IN THE PATIENT'S ANATOMY, A SURGICAL PROCEDURE WAS USED TO REMOVE THE SEPARATED PART OF THE WIRE GUIDE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5801698 ↗