Guidewire 395539Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886333211678), received between Dec 11, 2023 and Nov 9, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2024Difficult to Remove; Difficult to Remove

  ON (B)(6) 2024, AFTER INSERTING THE ICY CATHETER (LOT UNKNOWN) FROM THE FEMORAL VEIN ALONG THE GUIDEWIRE (LOT UNKNOWN), THE GUIDEWIRE COULD NOT BE REMOVED. EVEN WITH A CERTAIN AMOUNT OF FORCE, THE GUIDEWIRE COULD NOT BE REMOVED. SO, TO AVOID FURTHER STRAINING THE PATIENT, THE MEDICAL DOCTOR REMOVED THE CATHETER AND REINSERTED A NEW CATHETER. THIS TIME THE GUIDEWIRE WAS REMOVED WITHOUT ANY PROBLEMS, SO TEMPERATURE MANAGEMENT WAS INITIATED. THE EQUIPMENT IN QUESTION WAS DISCARDED, AND NO ADDITIONAL INFORMATION IS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646886 ↗
• MalfunctionDec 14, 2023Use of Device Problem; Use of Device Problem

  A PATIENT WAS HOSPITALIZED, AND THE NEED FOR IVTM THERAPY WAS TO INDUCE HYPOTHERMIA POST CARDIAC ARREST. THE QUATTRO CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN. THE INSERTION WAS DIFFICULT, AND PLACING THE CATHETER TOOK MULTIPLE ATTEMPTS (3 ATTEMPTS) BY AN EXPERIENCED INTENSIVE CARE PHYSICIAN. AFTER THE CATHETER INSERTION, THE PHYSICIAN HAD MULTIPLE PROBLEMS REMOVING THE GUIDEWIRE FROM THE QUATTRO CATHETER. THE PHYSICIAN HAD TO PULL BACK THE QUATTRO CATHETER SLIGHTLY TO REMOVE THE GUIDEWIRE. THE IVTM THERAPY WAS INITIATED AND CONTINUED USING THE SAME QUATTRO CATHETER WITHOUT FURTHER ISSUES. NO DEVICE MALFUNCTION WAS REPORTED ON THE CATHETER. THE PATIENT IS STABLE, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18330947 ↗
• MalfunctionDec 14, 2023Use of Device Problem; Use of Device Problem

  A 75-YEAR-OLD MALE PATIENT WAS HOSPITALIZED, AND THE NEED FOR IVTM THERAPY WAS TO INDUCE HYPOTHERMIA POST-CARDIAC ARREST. THE QUATTRO CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN. THE INSERTION WAS DIFFICULT, AND PLACING THE CATHETER TOOK MULTIPLE ATTEMPTS (3 ATTEMPTS) BY AN EXPERIENCED INTENSIVE CARE PHYSICIAN. AFTER THE CATHETER INSERTION, THE USER HAD MULTIPLE PROBLEMS REMOVING THE GUIDEWIRE AFTER THE CATHETER PLACEMENT. THE USER HAD TO PULL BACK THE QUATTRO CATHETER SLIGHTLY TO REMOVE THE GUIDEWIRE. THE IVTM THERAPY WAS INITIATED AND CONTINUED USING THE SAME QUATTRO CATHETER WITHOUT FURTHER ISSUES. NO DEVICE MALFUNCTION WAS REPORTED ON THE CATHETER. THE PATIENT IS STABLE, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18330945 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE INSERTING THE GUIDEWIRE INTO THE PATIENT'S VEIN TO INITIATE AN IVTM TREATMENT, THE PHYSICIAN NOTICED THAT THE GUIDEWIRE PENETRATED A BLOOD VESSEL. THE PHYSICIAN TRIED TO INSERT ANOTHER GUIDEWIRE, BUT IT PENETRATED A BLOOD VESSEL AGAIN. THESE INSERTION ATTEMPTS CAUSED INJURY TO THE PATIENT'S BLOOD VESSEL. PER THE REPORTER, THE PHYSICIAN IS INEXPERIENCED WITH INTRAVASCULAR CATHETER PLACEMENT. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THE INSERTION SITE(S) OR HOW THE TREATMENT CONTINUED AFTER THE SECOND PENETRATION OCCURRED. THE CUSTOMER DID NOT PROVIDE INFORMATION ON THE PATIENT'S CURRENT STATUS. THE TWO GUIDEWIRES WITH LOT NUMBERS 188014 AND 185168 WERE USED IN THE REPORTED EVENT; HOWEVER, IT IS UNKNOWN WHICH GUIDEWIRE WAS USED FIRST. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2023-01060 FOR GUIDEWIRE (LOT #185168).

  Patient problems: Perforation of Vessels

  MAUDE report 18307724 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE INSERTING THE GUIDEWIRE INTO THE PATIENT'S VEIN TO INITIATE AN IVTM TREATMENT, THE PHYSICIAN NOTICED THAT THE GUIDEWIRE PENETRATED A BLOOD VESSEL. THE PHYSICIAN TRIED TO INSERT ANOTHER GUIDEWIRE, BUT IT PENETRATED A BLOOD VESSEL AGAIN. THESE INSERTION ATTEMPTS CAUSED INJURY TO THE PATIENT'S BLOOD VESSEL. PER THE REPORTER, THE PHYSICIAN IS INEXPERIENCED WITH INTRAVASCULAR CATHETER PLACEMENT. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THE INSERTION SITE(S) OR HOW THE TREATMENT CONTINUED AFTER THE SECOND PENETRATION OCCURRED. THE CUSTOMER DID NOT PROVIDE INFORMATION ON THE PATIENT'S CURRENT STATUS. THE TWO GUIDEWIRES WITH LOT NUMBERS 188014 AND 185168 WERE USED IN THE REPORTED EVENT; HOWEVER, IT IS UNKNOWN WHICH GUIDEWIRE WAS USED FIRST. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2023-01061 FOR GUIDEWIRE (LOT #188014).

  Patient problems: Perforation of Vessels

  MAUDE report 18307715 ↗