Cook Spectrum G47825Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Catheter Set Minocycline/Rifampin Antibiotic Impregnated Triple Lumen Polyurethane · Class 2 · Implant
All models of Cook Spectrum (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00827002478251), received between Jun 26, 2017 and Nov 12, 2025 — classified as 9 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Fluid/Blood Leak8
- Crack6
- Break2
- Fracture2
- Leak/Splash2
- Obstruction of Flow2
- Unraveled Material2
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information4
- No Consequences Or Impact To Patient4
- No Code Available3
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
- Increased Level of Consciousness1
- No Patient Involvement1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BLUE LUMEN OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER WAS FOUND TO BE OCCLUDED PRIOR TO AN UNKNOWN PROCEDURE FOR A MALE PATIENT. DURING TESTING PRIOR TO INSERTION, THE NURSE NOTED THAT THE BLUE LUMEN OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER COULD NOT BE FLUSHED, AS RESISTANCE WAS FELT WHEN ATTEMPTING TO INJECT FLUID. A NEW SET WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23533883 ↗InjuryAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER FROM A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS LEAKING. UPON FLUSHING THE RED LUMEN WITH SALINE, THE NURSE NOTICED A SIGNIFICANT LEAK FROM THE INSERTION SITE. TO VERIFY THE LEAK WAS FROM THE CATHETER AND NOT THE PATIENT TISSUES, A SMALL AMOUNT OF PROPOFOL WAS INJECTED INTO THE RED LUMEN. THE WHITE COLORED PROPOFOL LIQUID WAS THEN NOTED TO LEAK FROM THE INSERTION SITE. THE CATHETER WAS REMOVED AND REPLACED IMMEDIATELY. AFTER REMOVAL, THE DEVICE WAS INSPECTED BY THE CUSTOMER. UPON FLUSHING THE WHITE AND BLUE LUMENS, THE CATHETER WAS NOTED TO FUNCTION NORMALLY WITH NO LEAKS. WHEN THE RED LUMEN WAS FLUSHED, LEAKING WAS NOTED FROM AN APPROXIMATE 1 CM LONG "HAIRLINE" CRACK AT THE MOST PROXIMAL PORTION OF THE CATHETER ("WHICH WOULD HAVE BEEN RIGHT ABOUT 5 MM INTO THE PATIENT'S SKIN"). THE SITE REPORTED THAT THE RED LUMEN HAD BEEN UTILIZED FOR INFUSIONS OF ANTIBIOTICS, A MAGNESIUM INFUSION, AND BALANCED ELECTROLYTE SOLUTION. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22702482 ↗MalfunctionJan 13, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE GUIDE WIRE OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS DISCOVERED TO BE KINKED AFTER REMOVAL FROM THE 78-YEAR-OLD MALE PATIENT. THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. DURING THE INSERTION OF THE WIRE GUIDE THERE WAS NO DIFFICULTY ADVANCING INTO THE PATIENT. HOWEVER, IT WAS REPORTED THAT THE WIRE GUIDE "FELT BLOCKED AND STUCK." THE WIRE GUIDE WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. UPON REMOVAL FROM THE PATIENT, IT WAS DISCOVERED THE GUIDE WIRE WAS KINKED. THE WIRE GUIDE WAS NOT MANIPULATED OR WITHDRAWN THROUGH THE NEEDLE. A NEW DEVICE "CVP" WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED TO COOK FOR INVESTIGATION ON (B)(6)2025. DURING THE PRELIMINARY INVESTIGATION OF THE RETURNED WIRE GUIDE, IT WAS DISCOVERED THAT THE WIRE GUIDE SAFETY WIRE BROKE AWAY FROM THE WELD CONNECTION AND RESULTED IN ELONGATION. ADDITIONALLY, TWO BENDS IN THE WIRE WERE IDENTIFIED. THE BENDS IN THE WIRE WERE INITIALLY REPORTED BY THE CUSTOMER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21139350 ↗InjuryJan 9, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IN ADDITIONAL INFORMATION RECEIVED ON 13JAN2025 AND 19JAN2025, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE USER REPORTED THAT NO DAMAGE WAS OBSERVED ON THE BLUE HUB.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21118151 ↗InjurySep 4, 2024Crack; Leak/Splash; Crack; Leak/Splash
IT WAS CLARIFIED BY THE CUSTOMER ON (B)(6) 2024 THAT THE CATHETER LEAKAGE OCCURRED AT THE "END HOLE" OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140770 ↗MalfunctionMay 6, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 19255841 ↗MalfunctionMay 6, 2024Crack; Crack
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 19255707 ↗InjurySep 7, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS PROVIDED. AS REPORTED, THE LUMENS WERE FILLED WITH SALINE SOLUTION PRIOR TO CATHETER INTRODUCTION. NO POWER INJECTION WAS USED; IT WAS NOT A CT PORT THAT CRACKED. THE LUMEN FLOW WAS NOT IMPEDED. THERE WERE NO REPORTED ISSUES WITH PATENCY. THE LINE WAS USED FOR CONTINUOUS INFUSION PRIOR TO LEAKAGE. THE LEAK OCCURRED BETWEEN THE HUB AND THE NEEDLELESS ADAPTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17700741 ↗InjuryFeb 22, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Increased Level of Consciousness
MAUDE report 16420240 ↗InjuryApr 13, 2022Fluid/Blood Leak; Fracture; Leak/Splash; Obstruction of Flow; Fluid/Blood Leak; Fracture; Leak/Splash; Obstruction of Flow
A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER WAS INSERTED IN THE NECK OF THE PATIENT ON (B)(6)2022. THE CATHETER WAS BEING USED FOR HIGH ACUITY PATIENT TREATMENT. WHEN THE LEAK WAS DISCOVERED, REMIFENTANIL AND PROPOFOL WERE BEING ADMINISTERED THROUGH THE PROXIMAL LUMEN. THE CATHETER WAS IMMEDIATELY CLAMPED AND TAPED OVER WHEN THE LEAK WAS DISCOVERED. THE INFUSION WAS TRANSFERRED TO ANOTHER PORT. THE CATHETER WAS REMOVED AND REPLACED ON (B)(6)2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14103705 ↗InjuryApr 4, 2022Material Separation; Material Separation
IT WAS REPORTED THE WIRE GUIDE IN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET SEPARATED. THE DEVICE WAS REQUIRED BY A PATIENT IN CRITICAL CONDITION FOR LARGE BORE, CENTRAL INTRAVENOUS (IV) ACCESS OF THE RIGHT FEMORAL VEIN. DURING THE PLACEMENT PROCEDURE, WHEN THE USER ADVANCED THE CATHETER OVER THE WIRE GUIDE AND INTO THE PATIENT, THE WIRE GUIDE SEPARATED. AN X-RAY WAS IMMEDIATELY TAKEN WHICH SHOWED APPROXIMATELY 22-23CM OF THE WIRE GUIDE RETAINED IN THE PELVIC VASCULATURE. THE PATIENT THEN REQUIRED AN ADDITIONAL PROCEDURE PERFORMED UNDER FLUOROSCOPY TO REMOVE THE WIRE GUIDE FRAGMENT. NO OTHER ADVERSE EVENTS WERE REPORTED DUE TO THIS OCCURRENCE. IT WAS NOTED THAT THE UNRETAINED PORTION OF THE WIRE GUIDE REMAINED INSIDE THE CATHETER. THE CATHETER WAS NOT PLACE IN THE PATIENT. IT WAS ALSO NOTED THE PROCEDURE WAS UNDERTAKEN BY EXPERIENCED STAFF AND WAS DESCRIBED AS UNCOMPLICATED WITH NO DIFFICULTY OR FORCE REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 13995798 ↗MalfunctionJul 13, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
DURING THE INVESTIGATION, IT WAS DETERMINED THIS EVENT WAS INADVERTENTLY REPORTED, AS IT DOES NOT MEET REPORTING CRITERIA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10264626 ↗MalfunctionJul 2, 2020Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE WIRE GUIDE OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS FOUND TO BE "DEFORMED" AFTER WITHDRAWAL. THE DEVICE WAS BEING PLACED IN THE PATIENT'S LEFT VENA SUBCLAVIA. RESISTANCE WAS FELT AS THE PHYSICIAN WAS WITHDRAWING THE WIRE GUIDE THROUGH THE NEEDLE. CONSEQUENTLY, THE PHYSICIAN WITHDREW BOTH THE NEEDLE AND WIRE TOGETHER. AFTER DOING SO, THE WIRE GUIDE WAS OBSERVED TO BE "DEFORMED". THE PHYSICIAN ATTEMPTED TO USE THE OTHER SIDE OF THE WIRE GUIDE BUT ENCOUNTERED THE SAME ISSUE. AS A RESULT, A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10227336 ↗MalfunctionMar 18, 2020Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9849610 ↗MalfunctionFeb 26, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 9756278 ↗MalfunctionNov 4, 2019Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION STATING THAT THE FITTING OF THE DEVICE WAS CONNECTED TO AN "AUTOMATIC CHEMICAL ADDITION AND CONTROL SYSTEM" AND THAT SYSTEM IS NOT AVAILABLE FOR RETURN. THE DEVICE WAS LEFT IN PLACE FOUR HOURS AFTER THE PROCEDURE AND WAS LOCKED WITH A NEEDLELESS CLOSED SYSTEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9272049 ↗MalfunctionJul 5, 2019Unraveled Material; Unraveled Material
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8765098 ↗MalfunctionJun 7, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 8680317 ↗InjurySep 21, 2018Crack; Crack
IT WAS REPORTED A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER (CVC) HUB WAS FOUND CRACKED. THE PATIENT WILL REQUIRE A LINE REPLACEMENT PROCEDURE WHEN CONDITIONS PERMIT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 7899062 ↗MalfunctionSep 27, 2017Break; Physical Resistance
WHEN THE DOCTOR TRIED TO REMOVE THE WIRE GUIDE FROM THE DISTAL CHANNEL, THE GUIDE PRESENTED A LOT OF RESISTANCE. WHEN THE DOCTOR FINALLY REMOVED THE WIRE GUIDE IT WAS "COMPLETELY DAMAGED". THE PATIENT DIDN'T EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6898534 ↗InjuryJun 26, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER ON (B)(6) 2017. THE CUSTOMER STATES THAT THE CENTER LUMEN OF THE TRIPLE LUMEN DEVICE WITH THE IV TUBING CONNECTED WAS DISCOVERED LYING IN THE PATIENT'S BED. THE CIRCUMSTANCES AND FORCES APPLIED TO THE DEVICE LEADING TO THE EVENT ARE NOT KNOWN. THE LINE WAS IMMEDIATELY REMOVED AND A NEW ONE INSERTED. NO FURTHER EVENT OR PATIENT DETAILS WERE PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 6667153 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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