Cook Spectrum G24137Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002241374), received between Sep 7, 2017 and Jun 26, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE WIRE GUIDE OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER WAS NOTED TO BE KINKED AFTER A DIFFICULT REMOVAL FROM THE PATIENT. THE PATIENT CODED UPON REMOVAL BUT SURVIVED WITH NO "KNOWN TRAUMA". AN ANESTHESIOLOGIST WAS PLACING A CENTRAL LINE IN A PATIENT IN THE INTENSIVE CARE UNIT (ICU). SHE INSERTED THE CATHETER AND THEN ATTEMPTED TO REMOVE THE WIRE GUIDE BUT FOUND "IT WOULD NOT COME OUT". AFTER MULTIPLE REMOVAL ATTEMPTS, SHE HAD TO "REMOVE THE ENTIRE LINE AND WHEN SHE DID THE PATIENT CODED". IT IS UNKNOWN AT THIS TIME WHAT ACTIONS WERE TAKEN TO TREAT THE PATIENT, BUT THE PATIENT DID SURVIVE THE CODE. IT WAS REPORTED THERE WAS NO "KNOWN TRAUMA CAUSED BY THE WIRE". UPON INSPECTION OF THE REMOVED WIRE, THE WIRE WAS NOTED TO BE BENT. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 10201483 ↗
• InjuryFeb 20, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CATHETER FROM A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY COILED WITHIN THE VESSEL. PATIENT DEATH OCCURRED MORE THAN 48 HOURS AFTER THE COILING WAS NOTICED. THE DEVICE WAS PLACED IN THE RIGHT FEMORAL VEIN WITH ULTRASOUND GUIDANCE. THE DEVICE DRESSING WAS INTACT, SUTURES WERE IN PLACE AND A CHLORHEXIDINE SPONGE WAS APPLIED. BLOOD WAS ASPIRATED FROM ALL LUMENS AFTER PLACEMENT, BUT IT WAS NOTED THAT THE DISTAL LUMEN WAS SLUGGISH. CENTRAL VENOUS PRESSURE WAS MONITORED FROM THE DISTAL LUMEN, AND IT WAS FOUND THAT THE CENTRAL VENOUS PRESSURE TRACING WAS DAMPENED. THE CLINICIANS CONTINUED TO PROCEED WITH TREATMENT USING THIS DEVICE BECAUSE IT WAS INSERTED UNDER ULTRASOUND GUIDANCE. CLINICIANS THOUGHT THAT THE DISTAL LUMEN INTRAVASCULAR PORT WAS LYING AGAINST THE VESSEL WALL LEADING TO DAMPENING OF THE WAVE. NO INTERVENTIONS WERE PERFORMED AS A RESULT OF THE DAMPENING OF THE WAVE. MEDICATIONS ADMINISTERED THROUGH THIS DEVICE INCLUDED PHENYLEPHRINE, NOREPINEPHRINE, VASOPRESSIN, AND LACTATED RINGERS SOLUTION. SEVEN HOURS AFTER DEVICE PLACEMENT, THE PATIENT DEVELOPED HYPOTENSION. VASOPRESSORS WERE ADDED AND MAXED OUT GRAD

  Patient problems: Death; Extravasation; No Code Available

  MAUDE report 8354954 ↗
• InjuryMay 4, 2018Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION HAS BEEN REPORTED SINCE THE SUBMISSION OF THE INITIAL REPORT ON 05/04/2018.

  Patient problems: No Code Available

  MAUDE report 7486088 ↗
• MalfunctionSep 7, 2017Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A CRACK IN THE HUB, WHICH RESULTED IN A CONTINUAL LEAK FROM THE PORT. THE CRACK WAS TAPED AND WRAPPED. BECAUSE THE PATIENT WAS REPORTEDLY DIFFICULT TO CATHETERIZE, THE CUSTOMER LEFT THE DEVICE IN AND PROVIDED CARE. THE ACCOUNT CONFIRMED THAT NO PATIENT ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848731 ↗