Cook Spectrum G47829Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00827002478299), received between Sep 19, 2016 and Dec 23, 2025 — classified as 20 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (18 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 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Crack; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882042 ↗
• MalfunctionJul 30, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CATHETER IN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET OCCLUDED DURING THE PROCEDURE. THE PHYSICIAN INSERTED THE CVC (CENTRAL VENOUS CATHETER) INTO THE RIGHT SUBCLAVIAN VEIN WHEN THE OCCLUSION WAS NOTED. THE LUMENS WERE SUCCESSFULLY FLUSHED AND FILLED WITH SALINE SOLUTION PRIOR TO CATHETER INTRODUCTION. IT WAS CONFIRMED THAT THE LUMENS WERE CLAMPED/INJECTION CAPS PLACED PRIOR TO INSERTION INTO THE PATIENT. A NEW SET WAS USED TO COMPLETE THE PROCEDURE. 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 22668837 ↗
• MalfunctionJul 28, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER BECAME OCCLUDED FOLLOWING PLACEMENT IN THE RIGHT SUBCLAVIAN VEIN OF AN 84-YEAR-OLD MALE PATIENT. THE PHYSICIAN EXPERIENCED RESISTANCE DURING INSERTION, MAKING IT HARD TO ADVANCE THE CATHETER. FOLLOWING PLACEMENT, BLOOD RETURN WAS DIFFICULT TO OBTAIN. AS A RESULT, THE PHYSICIAN REMOVED THE ENTIRE SET FROM THE PATIENT AND A NEW LIKE-DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637781 ↗
• MalfunctionJul 23, 2025Unraveled Material; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583525 ↗
• MalfunctionJun 11, 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. THE PHYSICIAN USED A NEW LIKE-DEVICE TO COMPLETE THE PROCEDURE. THE LUMENS WERE FILLED WITH SALINE/HEPARINIZED SOLUTION PRIOR TO CATHETER INTRODUCTION. ALL THE LUMENS WERE SUCCESSFULLY FLUSHED AND CLAMPED/INJECTION CAPS PLACED PRIOR TO PLACEMENT. IT WAS CONFIRMED THAT THE LUMENS WERE MAINTAINED WITH CONTINUOUS SALINE, HEPARINIZED SALINE DRIP OR LOCKED WITH SALINE SOLUTION. 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 22185132 ↗
• InjuryJan 7, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE WIRE INCLUDED IN THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET SEPARATED DURING A FEMORAL VEIN CENTRAL VENOUS CATHETER (CVC) INSERTION IN A 76-YEAR-OLD FEMALE PATIENT. AS THE DILATOR WAS BEING PLACED, THE USER FELT THE WIRE BREAK APPROXIMATELY 15CM FROM THE WIRE. THE PHYSICIAN WITHDREW THE DILATOR AND WIRE GUIDE, AND AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE SEPARATED PORTION OF THE WIRE GUIDE FROM THE PATIENT'S BODY. CENTRAL VENOUS PRESSURE (CVP) WAS BEING MONITORED THROUGH THE FEMORAL VEIN AND NO SIGNS OF SPAMS WERE IDENTIFIED. THE COMPLAINT DEVICE IS STILL IN THE HOSPITAL AND WILL BE RETRIEVED AFTER DISCUSSION BETWEEN THE FACILITY AND THE PATIENT'S FAMILY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21093416 ↗
• MalfunctionJan 2, 2025Obstruction of Flow; Obstruction of Flow

  ADDITIONAL INFORMATION WAS RECEIVED 16JAN2025. THE LUMENS WERE FILLED WITH SALINE SOLUTION PRIOR TO CATHETER INTRODUCTION. THE LUMENS WERE ABLE TO BE FLUSHED SUCCESSFULLY PRIOR TO PLACEMENT. THE UNUSED LUMENS WERE MAINTAINED BY BEING LOCKED WITH HEPARINIZED SALINE SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057919 ↗
• InjuryOct 30, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE END CONNECTOR OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER WAS BROKEN AND WOULD LEAK DURING INJECTION FOLLOWING PLACEMENT IN A 56-YEAR-OLD-MALE PATIENT. THE DEVICE WAS IN PLACE FOR ABOUT HALF A DAY WHEN IT WAS DISCOVERED THAT MEDICATION WAS LEAKING OUT OF THE CATHETER. FOLLOWING DISCOVERY OF THE LEAK, THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED. NO ADDITIONAL HARM TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570572 ↗
• MalfunctionAug 3, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE FROM A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS DIFFICULT TO ADVANCE. THE DILATOR WAS USED WHEN OBTAINING ACCESS TO THE SUBCLAVIAN VEIN. AFTER THE WIRE WAS INTRODUCED INTO THE VESSEL, IT WAS DIFFICULT TO ADVANCE. ADDITIONALLY, THE CATHETER WAS DIFFICULT TO ADVANCE OVER THE WIRE GUIDE. THE WIRE WAS THEN WITHDRAWN AND WAS FOUND "DEFORMED". A NEW DEVICE SET WAS OBTAINED TO FINISH THE PROCEDURE. IT WAS NOTED THE PATIENT HAD AN UNSPECIFIED ANATOMICAL ABNORMALITY THAT MADE ADVANCEMENT OF THE WIRE GUIDE DIFFICULT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE WIRE GUIDE WAS RECEIVED BY COOK ON 22JUL2024. UNRAVELING OF THE WIRE GUIDE WAS OBSERVED, THUS PROMPTING THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19902182 ↗
• MalfunctionMay 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLUE HUB FROM A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET LEAKED. THE FAILURE WAS NOTICED RIGHT AFTER PLACEMENT. 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 19260811 ↗
• MalfunctionApr 19, 2024Unraveled Material; Difficult to Advance; Unraveled Material; Difficult to Advance

  IT WAS REPORTED THAT THE WIRE INCLUDED IN THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET UNRAVELED UPON REMOVAL DURING AN UNKNOWN PROCEDURE ON A 55-YEAR-OLD MALE PATIENT. THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN ADVANCING THE WIRE INTO THE BLOOD VESSEL THROUGH THE NEEDLE. THE WIRE WAS THEN WITHDRAWN AND WAS FOUND TO BE "DEFORMED." A NEW LIKE-DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE CUSTOMER PROVIDED A PHOTO TO THE MANUFACTURER THAT SHOWED THE WIRE TO BE UNRAVELED. THE WIRE WAS WITHDRAWN OR MANIPULATED THROUGH THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19144988 ↗
• InjuryApr 16, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND COMING FROM THE BLUE PORT OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER FOLLOWING PLACEMENT IN THE LEFT NECK OF A 61-YEAR-OLD MALE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A CRACK IN THE CATHETER HUB. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121421 ↗
• InjuryApr 16, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121298 ↗
• InjuryApr 16, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IN ADDITIONAL INFORMATION IT WAS REPORTED THAT THE LEAK WAS NOTED IMMEDIATELY AFTER THE PROCEDURE DURING INJECTION. THE PATIENT REQUIRED REPLACEMENT OF THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121293 ↗
• MalfunctionApr 2, 2024Obstruction of Flow; Obstruction of Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019596 ↗
• MalfunctionMar 27, 2024Break; Unraveled Material; Deformation Due to Compressive Stress; Difficult to Advance; Break; Unraveled Material; Deformation Due to Compressive Stress; Difficult to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989287 ↗
• MalfunctionJan 31, 2024Unraveled Material; Deformation Due to Compressive Stress; Difficult to Advance; Unraveled Material; Deformation Due to Compressive Stress; Difficult to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615043 ↗
• MalfunctionDec 19, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356995 ↗
• MalfunctionAug 1, 2023Obstruction of Flow; Material Protrusion/Extrusion; Obstruction of Flow; Material Protrusion/Extrusion

  PER ADDITIONAL INFORMATION, THE FAILURE WAS DISCOVERED DURING THE INITIAL PLACEMENT PROCEDURE. THE LUMENS OF THE CATHETER WERE FLUSHED PRIOR TO INSERTION INTO THE PATIENT. LUMENS #2 AND #3 WERE FILLED WITH A SALINE SOLUTION OR HEPARINIZED SALINE SOLUTION PRIOR TO CATHETER INTRODUCTION. THE LUMENS WERE CLAMPED OR INJECTION CAPS WERE PLACED (EXCLUDING THE DISTAL EXTENSION) PRIOR TO INSERTION INTO THE PATIENT. THE LUMENS WERE ABLE TO BE FLUSHED AFTER PLACEMENT. UNUSED LUMENS ARE HEPARIN-LOCKED, AND THE LOCK IS REESTABLISHED 24 HOURS AT A TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437874 ↗
• MalfunctionJul 26, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ADDITIONAL INFORMATION WAS PROVIDED ON 28JUL2023. THE LEAKAGE OCCURRED AT THE JUNCTION OF THE BLUE HUB AND THE EXTENSION TUBING. AFTER CATHETER PLACEMENT, THE MAINTENANCE PROTOCOL FOR THE DEVICE, WHICH IS COMPLETED BY THE NURSES, IS TO FLUSH THE LUMENS USING NORMAL SALINE. THE CATHETER WAS REMOVED AND REPLACED. BASED ON PREVIOUS INFORMATION PROVIDED REGARDING PATIENT OUTCOME (NO ADDITIONAL PROCEDURES REQUIRED), IT IS REASONABLE TO PRESUME THAT THIS OCCURRED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17400379 ↗
• MalfunctionMar 27, 2023Unraveled Material; Difficult to Advance; Material Twisted/Bent; Unraveled Material; Difficult to Advance; Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622471 ↗
• MalfunctionFeb 21, 2023Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414268 ↗
• MalfunctionOct 4, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THE PATIENT REQUIRED REPLACEMENT OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. AFTER THE PROCEDURE WAS COMPLETED, THE DOCTOR OBSERVED THE CATHETER AND DISCOVERED THE OCCLUDED LUMEN OF THE BLUE PORT. THE CATHETER WAS REPLACED WITH A NEW CATHETER IMMEDIATELY FOLLOWING THE OBSERVATION. NO OTHER ADVERSE AFFECTS WERE REPORTED FOR THIS INCIDENT. 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 15538881 ↗
• MalfunctionJun 27, 2022Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  DURING THE PROCEDURE TO PLACE A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER, THE PHYSICIAN FELT RESISTANCE WHEN ADVANCING THE WIRE GUIDE INTO THE PATIENT. THE WIRE GUIDE WAS NOT ALTERED FROM IT'S ORIGINAL SHAPE PRIOR TO USE. THE "J CURVE" END OF THE WIRE GUIDE WAS THE END OF THE WIRE GUIDE THAT WAS ADVANCED. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE TORTUOUS, CALCIFIED, OR SCARRED ANATOMY. THE CLINICIAN REMOVED THE WIRE GUIDE AND DISCOVERED IT WAS "DEFORMED/KINKING." ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. THE WIRE GUIDE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND IT WAS DISCOVERED TO BE UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828403 ↗
• MalfunctionMay 4, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE BLUE AND WHITE LUMENS OF THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER OCCLUDED AFTER BEING PLACED IN A (B)(6) MALE PATIENT. AS THE CASE WAS AN EMERGENT SITUATION, THE PHYSICIAN DID NOT FLUSH EACH OF THE LUMENS PRIOR TO USE. FOLLOWING DEVICE PLACEMENT IN THE RIGHT FEMORAL VEIN, IT WAS DISCOVERED THAT THE WHITE AND BLUE LUMENS OF THE CATHETER WERE OCCLUDED WHEN BLOOD WAS UNABLE TO BE "REFLUXED BY INFUSION." THE PHYSICIAN THEN REMOVED THAT ENTIRE CATHETER AND REPLACED IT WITH A NEW SET. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274185 ↗