Cook Spectrum G51539Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002515390), received between Aug 5, 2020 and Jun 6, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 5, 2026Class IIOpen, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1788-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

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.

• MalfunctionJun 6, 2022Break; Unraveled Material; Deformation Due to Compressive Stress; Break; Unraveled Material; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE GUIDEWIRE INCLUDED IN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER SET BROKE DURING A CENTRAL LINE INSERTION PROCEDURE ON AN UNKNOWN PATIENT. UPON REMOVAL OF THE DILATOR DURING PLACEMENT, IT WAS NOTICED THAT THE GUIDEWIRE WAS BROKEN. THE PHYSICIAN WAS ABLE TO REMOVE THE WIRE FROM THE PATIENT ENTIRELY AND COMPLETE THE PROCEDURE SUCCESSFULLY. THE PHYSICIAN WAS REPORTED TO HAVE EXPERIENCED BLOOD AND BODILY FLUID EXPOSURE FROM A SHARP THAT RESULTED FROM THE BROKEN WIRE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603627 ↗
• InjuryMay 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK WAS DISCOVERED IN THE FIRST LUMEN OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER. THE LINE WAS PLACED INTO THE LEFT INTERNAL JUGULAR VEIN OF THE PATIENT ON THE EVENING OF (B)(6) 2022 FOR HIGH ACUITY TREATMENT. THIRTY-SIX HOURS LATER, ON (B)(6) 2022, A LEAK WAS FOUND DURING THE ADMINISTRATION OF PROPOFOL, REMIFENTANIL AND DEXMEDETOMIDINE. THE LUMEN WAS IMMEDIATELY CLAMPED AND TAPED OVER WHILE THE INFUSION WAS TRANSFERRED TO ANOTHER PORT. THE LINE WAS ULTIMATELY REMOVED AND REPLACED ON (B)(6) 2022. THERE WAS NO INDICATION OF UNDUE FORCE APPLIED WHEN ATTACHING IV ACCESS HUB TO THE PORTS. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274291 ↗
• InjuryApr 22, 2022Break; Material Separation; Break; Material Separation

  DURING THE PLACEMENT PROCEDURE FOR A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER, THE DILATOR WAS REMOVED OVER THE GUIDEWIRE AND THE GUIDEWIRE THEN SEPARATED. THE REMAINING PORTION OF THE GUIDE WIRE MEASURING 35 CM REMAINED IN THE PATIENT'S VESSEL. THE REMAINING PORTION OF THE GUIDEWIRE WAS REMOVED IN A SECONDARY INTERVENTIONAL RADIOLOGY PROCEDURE. NO FURTHER ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14189157 ↗
• InjuryAug 5, 2020Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10368886 ↗