Cook Spectrum G44128Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002441286), received between Sep 18, 2017 and Feb 26, 2026 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (5 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Nonstandard Device

  IT WAS REPORTED THAT THE CATHETERS SUPPLIED IN COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAYS WERE THE INCORRECT LENGTH. IN RELATION TO THE EVENT WITH PATIENT IDENTIFIER (B)(6), THREE PRIOR TO USE DEVICES WERE RETURNED FOR EVALUATION. ALL THREE CATHETERS MEASURED 15 CM IN LENGTH AND WERE MARKED WITH 15 CM ON THE MANIFOLD. HOWEVER, THE PACKAGING IS LABELED FOR 20 CM LENGTH CATHETERS. THESE DEVICES WERE NOT USED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457349 ↗
• MalfunctionFeb 10, 2026Nonstandard Device; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY CONTAINED A 15 CM LENGTH CATHETER INSTEAD OF A 20 CM LENGTH CATHETER AS STATED ON THE PACKAGING LABEL. THE ISSUE WAS NOTED UPON THE PACKAGING, AND THE DEVICE WAS NOT USED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305441 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Device Markings/Labelling Problem; Nonstandard Device; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY CONTAINED AN INCORRECT SIZE CATHETER. A 7.0FR/15CM CENTRAL VENOUS CATHETER WAS FOUND IN PACKAGING LABELED 7.0FR/20CM. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23282032 ↗
• InjuryJul 30, 2025Nonstandard Device; Device Markings/Labelling Problem; Nonstandard Device; Device Markings/Labelling Problem

  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 22667966 ↗
• InjuryApr 2, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IN ADDITIONAL INFORMATION RECEIVED ON 01APR2025, IT WAS REPORTED THAT THE COMPLAINT DEVICE WAS PLACED IN THE PATIENT ON (B)(6) 2025. DUE TO A CRACK IN THE LUMEN FOUND ON (B)(6) 2025, THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW DEVICE. THE PATIENT NEEDED ASSISTANCE TO GET TO INTO A CHAIR NEXT TO THE BED AND WAS UNABLE TO WALK AROUND THE ROOM OR UNIT. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753511 ↗
• InjuryFeb 20, 2025Crack; Crack

  IT WAS REPORTED THAT BLUE CATHETER PORTS FROM COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAYS WERE NOTED TO BE CRACKED AND LEAKING. ONE PATIENT REQUIRED THREE CENTRAL LINE REPLACEMENTS BECAUSE OF THIS ISSUE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424231 ↗
• InjuryDec 30, 2024Crack; Crack

  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 21039757 ↗
• InjuryDec 30, 2024Crack; Crack

  IT WAS REPORTED THAT AN UNKNOWN LUMEN HUB OF A COOK SPECTRUM MINOCYCLINE-RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY CRACKED ON (B)(6) 2024. THE DEVICE WAS PLACED ON (B)(6) 2024 FOR SEVEN DAYS BEFORE THE FAILURE OCCURRED AND WAS REPLACED ON (B)(6) 2024. THE INSERTION LOCATION WAS IN THE "CAS". NO CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (CLABSI) WAS REPORTED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THE DATES OF FIVE OTHER EVENTS WITH THE SAME CRACK HUB FAILURE WERE PROVIDED AND ARE REPORTED UNDER PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037123 ↗
• InjuryDec 5, 2024Crack; Crack

  ADDITIONAL INFORMATION WAS RECEIVED 31DEC2024. THE CATHETER WAS REPLACED AT BEDSIDE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854211 ↗
• MalfunctionJul 12, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE SCALPEL INCLUDED IN THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY WAS FOUND TO BE RUSTED DURING AN UNKNOWN PROCEDURE ON A PATIENT OF UNKNOWN AGE AND GENDER. THE MEDICAL STAFF HAD ALREADY USED THE REST OF THE KIT BEFORE SEEING THE SCALPEL. THE RUSTED SCALPEL WAS NOT USED ON THE PATIENT. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19732635 ↗
• InjuryApr 21, 2022Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT REQUIRED PLACEMENT OF RIGHT FEMORAL CENTRAL LINE FROM A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY USING THE SELDINGER TECHNIQUE. AFTER PLACEMENT OF THE DEVICE, A RETAINED GUIDEWIRE EXTENDING INTO THE HEART WAS FOUND DURING X-RAY CONFIRMATION. THE WIRE WAS THEN SUCCESSFULLY REMOVED WITH AN ADDITIONAL INTERVENTIONAL RADIOLOGY PROCEDURE THAT INCLUDED INTUBATION AND SEDATION. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14167616 ↗
• InjuryFeb 17, 2021Partial Blockage; 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 Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11336925 ↗
• MalfunctionSep 11, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY WAS FOUND TO BE UNRAVELED DURING A CENTRAL VENOUS CATHETER INSERTION. NO ADVERSE EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.

  Patient problems: No Information

  MAUDE report 10521271 ↗
• MalfunctionSep 18, 2017No Flow

  THE CUSTOMER REPORTED THAT AFTER INSERTING THE CENTRAL LINE INTO THE PATIENT, IT WAS VERY DIFFICULT TO FLUSH. THE LINE WAS REMOVED, BUT THE ATTEMPTS TO FLUSH THE LINE WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PARTS OF THE DEVICE WERE LEFT INSIDE THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  MAUDE report 6873815 ↗
• InjurySep 18, 2017Bent; Coiled; Kinked; Failure to Advance

  DURING AN ATTEMPT TO INSERT A CENTRAL VENOUS CATHETER INTO THE FEMORAL VEIN, DIFFICULTY WAS ENCOUNTERED WITH THE WIRE KINKING, BENDING AND COILING, INHIBITING THE PASSAGE OF THE CATHETER. THE PROCEDURE WAS BEING PERFORMED ON AN ELDERLY MALE PATIENT THAT WAS IN SHOCK, REQUIRING VASOPRESSORS. THE PROCEDURE WAS PERFORMED BY A PULMONARY FELLOW UNDER THE SUPERVISION OF AN ATTENDING PHYSICIAN. ULTRASOUND OF THE AREA DID NOT INDICATE ANY DEVIATIONS IN THE PATIENT¿S ANATOMY BOTH PROXIMAL AND DISTAL TO THE INSERTION SITE. THE NEEDLE WAS INSERTED WITHOUT ISSUE UNDER ULTRASOUND GUIDANCE; THE WIRE WAS ADVANCED TO THE LOWER 1/3 OF THE SUPERIOR VENA CAVA. THE NEEDLE WAS REMOVED AND A SMALL SKIN NICK WAS MADE ON BOTH SIDES OF THE WIRE. THE DILATOR WAS INSERTED OVER THE WIRE AND IT IS UNCLEAR IF THERE WAS ANY ISSUE INSERTING THE DILATOR. AT SOME POINT IN THE DILATION, THE FELLOW DESCRIBED THE WIRE AS GOING SLACK OR LOSING RIGIDITY. THE DILATOR WAS REMOVED AND THE CATHETER WAS INSERTED OVER THE WIRE. AT THIS POINT THE CATHETER DID NOT ADVANCE AS EXPECTED. THE FELLOW REMOVED THE CATHETER AND THE WIRE. IT WAS NOTED THAT THERE WAS A "HUGE" KINK IN THE PROXIMAL END OF THE WIRE APPROXIMATELY AT THE DIST

  MAUDE report 6872132 ↗