Cook Spectrum G53599Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Catheter Set Minocycline/Rifampin Antibiotic Impregnated Triple Lumen Polyurethane · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002535992), received between Sep 12, 2017 and May 18, 2023 — classified as 6 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Partial Blockage” (4 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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 5, 2026Open, 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 · FDA record ↗
Most reported problems
Device problems
- Partial Blockage4
- Complete Blockage2
- Material Separation2
- Break1
- Flaked1
- Torn Material1
Patient problems
- No Code Available5
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Chills1
- Fever1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2023Material Separation; Material Separation
IT WAS REPORTED THE WIRE GUIDE OF COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET SEPARATED IN AN UNKNOWN PATIENT IN THE INTENSIVE CARE UNIT. DURING THE PLACEMENT OF A LEFT SUBCLAVIAN CENTRAL VENOUS CATHETER UNDER ULTRASOUND GUIDANCE, THE WIRE GUIDE AND CATHETER INSERTION WAS REPORTED TO BE UNEVENTFUL. THE WIRE GUIDE SEPARATED WHEN BEING REMOVED WITH MINIMAL RESISTANCE. THE SEPARATED WIRE GUIDE WAS REMOVED FROM THE PATIENT UNDER FLUOROSCOPY IMAGING IN THE CATHETERIZATION LABORATORY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16955802 ↗MalfunctionSep 29, 2020Flaked; Flaked
UPON RECEIVING THE DEVICE, IT WAS DISCOVERED THAT THE ABRM COATING HAD CAME OFF RATHER THAN THE HYDROPHILIC COATING. A DATABASE SEARCH FOUND NO INDICATION OF A HEIGHTENED PATIENT RISK ASSOCIATED WITH THIS FAILURE MODE WITH THIS DEVICE. THEREFORE, THIS EVENT IS NOW CONSIDERED TO BE NOT REPORTABLE; NO FURTHER REPORTS WILL BE SUBMITTED REGARDING THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10600698 ↗InjuryFeb 18, 2020Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE LUMENS OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WERE GETTING BLOCKED AFTER PLACEMENT. CONSEQUENTLY, "SAMPLING AND MEDICATION" WERE UNABLE TO BE DONE THROUGH THE CATHETER. THE CATHETER WAS FLUSHED "WITH HEPARIN FREQUENTLY AND MANAGED". IT WAS ALSO REPORTED THAT AN ADDITIONAL CATHETER WAS INSERTED TO CONTINUE TREATMENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND DEVICE HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Code Available
MAUDE report 9719928 ↗InjuryFeb 17, 2020Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE LUMENS OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WERE GETTING BLOCKED AFTER PLACEMENT. CONSEQUENTLY, "SAMPLING AND MEDICATION" WERE UNABLE TO BE DONE THROUGH THE CATHETER. THE CATHETER WAS FLUSHED "WITH HEPARIN FREQUENTLY AND MANAGED". IT WAS ALSO REPORTED THAT AN ADDITIONAL CATHETER WAS INSERTED TO CONTINUE TREATMENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND DEVICE HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Code Available
MAUDE report 9718736 ↗InjuryFeb 11, 2020Complete Blockage; Complete Blockage
IT WAS REPORTED THAT A THE LUMEN OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER WAS BLOCKED, RESULTING IN AN INTERRUPTION OF TREATMENT. THE CATHETER WAS INSERTED ON (B)(6) 2020 FOR IMPROVING NUTRITION. A "BLOCKED 2ND CATHETER" WAS REPORTED ON (B)(6) 2020. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN WITHIN 72 HOURS. THE REPLACEMENT OF THE CATHETER RESULTED IN AN INTERRUPTION OF PLANNED TREATMENT. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED FEVER, CHILLS, AND "RIGOR" DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PRODUCT AND EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Chills; Fever; No Code Available
MAUDE report 9693193 ↗InjuryJan 21, 2020Complete Blockage; Complete Blockage
IN ADDITIONAL INFORMATION RECEIVED ON 03FEB2020, IT WAS REPORTED THAT THE CATHETERS WERE IN PLACE FOR 2 DAYS AFTER PLACEMENT. THE LINE WAS BEING USED FOR MEDICATION INFUSION AND BLOOD SAMPLING. THE FACILITY REPORTED THAT THE LUMENS WERE FLUSHED WITH HEPARIN IN EVERY PROCEDURE AND "USED OUR LOCK ONLY."
Patient problems: No Code Available
MAUDE report 9611543 ↗InjuryJan 13, 2020Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE LUMENS OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WERE GETTING BLOCKED AFTER PLACEMENT. CONSEQUENTLY, "SAMPLING AND MEDICATION" WERE UNABLE TO BE DONE THROUGH THE CATHETER. IT WAS ALSO REPORTED THAT "IN SOME CASES", AN ADDITIONAL CATHETER WAS INSERTED TO CONTINUE TREATMENT. THE CATHETER WAS FLUSHED "WITH HEPARIN FREQUENTLY AND MANAGED". ADDITIONAL INFORMATION REGARDING THE EVENT AND DEVICE HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Code Available
MAUDE report 9581013 ↗MalfunctionSep 19, 2017Partial Blockage
THE CUSTOMER REPORTED THAT AFTER INSERTING THE CATHETER, THE LUMEN WAS FOUND TO BE BLOCKED AT THE BIFURCATION. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6877517 ↗MalfunctionSep 14, 2017Torn Material
IT WAS REPORTED THAT UPON CHECKING THE DEVICE PACKAGING, IT WAS NOTED THE POUCH PACKAGE WAS TORN. DEVICE IMAGING IDENTIFIED THE TEAR WAS NOT EASILY VISIBLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6866321 ↗MalfunctionSep 12, 2017Break; Material Separation
IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, THE TIP OF THE GUIDE WIRE WAS BROKEN. DEVICE IMAGING IDENTIFIED COIL SEPARATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6858726 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.