Guidewire 395613Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886333211753), received between Nov 19, 2024 and Nov 19, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Retraction Problem; Retraction Problem

  THE QUATTRO CATHETER (LOT # 208953) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN. AFTER THE INSERTION, THE CUSTOMER WAS UNABLE TO RETRACT THE GUIDEWIRE TO REMOVE IT. THEREFORE, THE PHYSICIAN HAD TO REMOVE BOTH THE CATHETER AND THE GUIDEWIRE. A NEW CATHETER KIT WAS USED AND INSERTED WITHOUT PROBLEMS. THERE WERE NO COMPLAINTS OR ISSUES WITH THE CATHETER. NO PATIENT INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597822 ↗
• MalfunctionDec 30, 2024Retraction Problem; Retraction Problem

  THE CUSTOMER REPORTED AN ISSUE WITH ADVANCING THE QUATTRO CATHETER (LOT # 200089) AND RETRACTING THE GUIDEWIRE DURING CATHETER INSERTION INTO A PATIENT'S FEMORAL VEIN. THE GUIDEWIRE BECAME STUCK AND COULD NOT BE REMOVED, SO BOTH THE CATHETER AND GUIDEWIRE WERE TAKEN OUT TOGETHER WITHOUT ANY SURGICAL INTERVENTION OR ISSUES. A NEW GUIDEWIRE WAS USED TO INSERT A REPLACEMENT CATHETER AT THE SAME INSERTION SITE. THIS INCIDENT OCCURRED IN THE PAST AND WAS NOT REPORTED TO ZOLL AT THE TIME. UNFORTUNATELY, THE ATTENDING PHYSICIAN NO LONGER RECALLS WHICH PATIENT IT WAS, ONLY THAT THE PATIENT HAD DIED FROM ANOTHER CAUSE. THE CUSTOMER SUSPECTS THAT THERE WAS A TIGHTER BEND IN THE VESSEL, WHICH MADE IT SOMEWHAT MORE DIFFICULT TO ADVANCE THE CATHETER AND REMOVE THE GUIDEWIRE. NO PATIENT INJURY RELATED TO THE ZOLL DEVICE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044636 ↗
• MalfunctionDec 5, 2024Difficult to Remove; Difficult to Remove

  DURING MULTIPLE ATTEMPTS, THE CUSTOMER HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM THE QUATTRO CATHETER. THREE QUATTRO CATHETERS AND ZOLL GUIDEWIRES WERE ATTEMPTED TO INSERT INTO THE FEMORAL VEIN (RIGHT AND LEFT SIDES). EACH ATTEMPT WAS DIFFICULT AND REQUIRED MULTIPLE INSERTIONS. THE CUSTOMER REPORTED THAT THE GUIDEWIRE COULD NOT BE REMOVED FROM ANY OF THE THREE CATHETERS, AND THE CATHETER HAD TO BE REMOVED ALONG WITH THE GUIDEWIRE EACH TIME. PER THE CUSTOMER, THE PHYSICIAN'S EXPERIENCE WITH INTRAVASCULAR CATHETER PLACEMENT WAS FREQUENT, AND PER THE PHYSICIAN, THERE WAS NO INCREASED TORTUOSITY IN THE VEIN. NO PATIENT INJURY WAS REPORTED. THE CUSTOMER SAVED ONLY ONE CATHETER (LOT #198059) WITH GUIDEWIRE (LOT #199681) FOR INVESTIGATION. THE LOT NUMBERS OF THE TWO OTHER CATHETERS AND THE GUIDEWIRES ARE UNKNOWN, AND THE CUSTOMER HAS DISPOSED OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859357 ↗
• MalfunctionDec 5, 2024Difficult to Remove; Difficult to Remove

  DURING MULTIPLE ATTEMPTS, THE CUSTOMER HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM THE QUATTRO CATHETER. THREE QUATTRO CATHETERS AND ZOLL GUIDEWIRES WERE ATTEMPTED TO INSERT INTO THE FEMORAL VEIN (RIGHT AND LEFT SIDES). EACH ATTEMPT WAS DIFFICULT AND REQUIRED MULTIPLE INSERTIONS. THE CUSTOMER REPORTED THAT THE GUIDEWIRE COULD NOT BE REMOVED FROM ANY OF THE THREE CATHETERS, AND THE CATHETER HAD TO BE REMOVED ALONG WITH THE GUIDEWIRE EACH TIME. PER THE CUSTOMER, THE PHYSICIAN'S EXPERIENCE WITH INTRAVASCULAR CATHETER PLACEMENT WAS FREQUENT, AND PER THE PHYSICIAN, THERE WAS NO INCREASED TORTUOSITY IN THE VEIN. NO PATIENT INJURY WAS REPORTED. THE CUSTOMER SAVED ONLY ONE CATHETER (LOT #198059) WITH GUIDEWIRE (LOT #199681) FOR INVESTIGATION. THE LOT NUMBERS OF THE TWO OTHER CATHETERS AND THE GUIDEWIRES ARE UNKNOWN, AND THE CUSTOMER HAS DISPOSED OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859241 ↗
• MalfunctionDec 5, 2024Difficult to Remove; Difficult to Remove

  DURING MULTIPLE ATTEMPTS, THE CUSTOMER HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM THE QUATTRO CATHETER. THREE QUATTRO CATHETERS AND ZOLL GUIDEWIRES WERE ATTEMPTED TO INSERT INTO THE FEMORAL VEIN (RIGHT AND LEFT SIDES). EACH ATTEMPT WAS DIFFICULT AND REQUIRED MULTIPLE INSERTIONS. THE CUSTOMER REPORTED THAT THE GUIDEWIRE COULD NOT BE REMOVED FROM ANY OF THE THREE CATHETERS, AND THE CATHETER HAD TO BE REMOVED ALONG WITH THE GUIDEWIRE EACH TIME. PER THE CUSTOMER, THE PHYSICIAN'S EXPERIENCE WITH INTRAVASCULAR CATHETER PLACEMENT WAS FREQUENT, AND PER THE PHYSICIAN, THERE WAS NO INCREASED TORTUOSITY IN THE VEIN. NO PATIENT INJURY WAS REPORTED. THE CUSTOMER SAVED ONLY ONE CATHETER (LOT #198059) WITH GUIDEWIRE (LOT #199681) FOR INVESTIGATION. THE LOT NUMBERS OF THE TWO OTHER CATHETERS AND THE GUIDEWIRES ARE UNKNOWN, AND THE CUSTOMER HAS DISPOSED OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858938 ↗
• MalfunctionNov 19, 2024Difficult to Remove; Material Integrity Problem; Material Twisted/Bent; Difficult to Remove; Material Integrity Problem; Material Twisted/Bent

  AT THE START OF IVTM THERAPY, THE PATIENT'S TEMPERATURE WAS 30°C, WITH A TARGET OF 36.5°C FOR CONTROLLED HYPOTHERMIA. WHILE THE QUATTRO CATHETER (LOT #UNKNOWN) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN, THE CUSTOMER REPORTED DIFFICULTY REMOVING THE GUIDEWIRE. THE GUIDEWIRE COULD NOT BE PULLED OUT, WAS COMPLETELY STRETCHED, AND VISUALLY BECAME SPIRAL. DESPITE THIS, THE EXPERIENCED SENIOR ICU PHYSICIAN EXTRACTED THE GUIDEWIRE AND PROCEEDED WITH THE THERAPY USING THE QUATTRO CATHETER. THE CUSTOMER REPORTED NO MALFUNCTIONS OR ISSUES WITH THE CATHETER. THE PATIENT WAS SEDATED AND VENTILATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730323 ↗