Cook Spectrum G50817Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002508170), received between Aug 8, 2017 and Jun 6, 2022 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (7 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

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE IN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER KINKED. WHEN ADVANCING THE WIRE GUIDE INTO THE PATIENT, THE USER ENCOUNTERED RESISTANCE. THE WIRE GUIDE WAS THEN REMOVED AND A KINK WAS OBSERVED. A NEW DEVICE WAS OBTAINED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ON (B)(6) 2022, THE DEVICE WAS RETURNED TO COOK AND ELONGATION WAS NOTED, THUS PROMPTING THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605133 ↗
• MalfunctionJun 6, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE IN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER KINKED. WHEN ADVANCING THE WIRE GUIDE INTO THE PATIENT, THE USER ENCOUNTER RESISTANCE. THE WIRE GUIDE WAS THEN REMOVED AND A KINK WAS OBSERVED. A NEW DEVICE WAS OBTAINED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ON 01JUN2022, THE DEVICE WAS RETURNED TO COOK AND ELONGATION WAS NOTED, THUS PROMPTING THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605116 ↗
• MalfunctionDec 2, 2021Unraveled Material; Unraveled Material

  IT WAS REPORTED A (B)(6), FEMALE PATIENT UNDERWENT PLACEMENT OF A COOK SPECTRUM MINOCYCLINE /RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER. WHILE THE PHYSICIAN WAS ADVANCING THE WIRE GUIDE INTO THE PATIENT, HE FELT RESISTANCE. HE WITHDREW THE WIRE AND FOUND IT "DEFORMED." A PROVIDED PHOTO OF THE DEVICE SHOWED UNRAVELING OF THE WIRE GUIDE. THE PHYSICIAN COMPLETED THE PROCEDURE BY USING ANOTHER SET. THE ANATOMICAL SITE OF PLACEMENT WAS THE RIGHT RIB. THE ANATOMY OF THE ACCESS VESSEL WAS NOT TORTUOUS. NO DIFFICULTY WAS NOTICED AFTER THE NEEDLE WAS REMOVED. IMAGING WAS NOT USED IN THE PLACEMENT OF THE DEVICE. 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 12920481 ↗
• MalfunctionJul 23, 2021Difficult to Remove; Unraveled Material; Deformation Due to Compressive Stress; Difficult to Remove; Unraveled Material; Deformation Due to Compressive Stress

  IT WAS REPORTED A PATIENT REQUIRED A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER. AFTER THE CATHETER WAS PLACED IN THE PATIENT'S SUBCLAVIAN VEIN, THE USER EXPERIENCED DIFFICULTY REMOVING THE WIRE GUIDE FROM THE CATHETER. AS A RESULT, THE USER REMOVED THE DEVICE IN ITS ENTIRETY AND COMPLETED THE PROCEDURE WITH A LIKE DEVICE. A PHOTO PROVIDED BY THE CUSTOMER DEPICTS UNRAVELING OF THE WIRE GUIDE. IT WAS NOTED THAT THE WIRE GUIDE WAS NEVER REMOVED THROUGH A NEEDLE. NO KINKING OR BENDING OF THE WIRE GUIDE WAS NOTED DURING THE PROCEDURE. NO DIFFICULTY ADVANCING THE WIRE GUIDE WAS EXPERIENCED. 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 12220871 ↗
• MalfunctionMay 19, 2021Obstruction of Flow; Obstruction of Flow

  NO NEW PATIENT AND/OR EVENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852479 ↗
• MalfunctionMay 19, 2021Difficult to Remove; Material Separation; Difficult to Remove; 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 11852397 ↗
• MalfunctionOct 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PLACEMENT OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER IN THE PATIENT'S SUBCLAVIAN VEIN, THE PHYSICIAN FELT RESISTANCE WHEN WITHDRAWING THE WIRE GUIDE. THE PHYSICIAN REMOVED THE CATHETER AND WIRE GUIDE TOGETHER. A NEW SET WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. UPON RECEIVING THE DEVICE, IT WAS OBSERVED THAT THE WIRE GUIDE HAD SEPARATED, THUS PROMPTING THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10765620 ↗
• MalfunctionJul 2, 2020Material Deformation; Material Deformation

  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 10227351 ↗
• MalfunctionDec 31, 2019Unraveled Material; Unraveled Material

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9535831 ↗
• MalfunctionDec 2, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRIMARY PACKAGING OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS DAMAGED PRIOR TO PATIENT CONTACT. A SMALL HOLE IN THE BACK OF THE PACKAGE WAS OBSERVED DURING INSPECTION. NO ADVERSE EFFECTS HAVE OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9396849 ↗
• MalfunctionJul 5, 2019Unraveled Material; Unraveled Material

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8765076 ↗
• MalfunctionJan 31, 2019Material Separation; Material Separation

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8294409 ↗
• InjuryJan 10, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER THE PLACEMENT OF THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER THE CATHETER BECAME OCCLUDED. THE DEVICE WAS REPLACED SUCCESSFULLY WITH ANOTHER DEVICE IN THE SAME PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8233559 ↗
• MalfunctionDec 21, 2018Material Deformation; Material Deformation

  IT WAS REPORTED A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS PLACED IN THE SUBCLAVIAN VEIN. INSERTION OF THE WIRE GUIDE AND CATHETER WERE PERFORMED WITH NO ISSUE. UPON REMOVAL OF THE WIRE GUIDE, THE WIRE BECAME "STUCK" IN THE CATHETER. THE PHYSICIAN MANIPULATED AND THE WIRE AND USED FORCE TO SUCCESSFULLY WITHDRAW THE WIRE. OBSERVATION OF THE WIRE AFTER REMOVAL REVEALED IT WAS DEFORMED. COOK INC. RECEIVED AND EVALUATED THE USED DEVICE. THE DEVICE WAS DETERMINED TO HAVE ELONGATED; THEREFORE, THIS EVENT IS BEING REPORTED AS A MALFUNCTION. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE SCHEDULED PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8192374 ↗
• MalfunctionSep 20, 2017Bent; Kinked; Bent; Kinked

  THE INTERNATIONAL CUSTOMER REPORTED THAT, AFTER A SUCCESSFUL INSERTION OF THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER INTO THE RIGHT INTERNAL JUGULAR VEIN OF THE PATIENT OVER THE GUIDEWIRE, THE GUIDEWIRE BEGAN TO KINK AND BEND WHEN THE OPERATOR ATTEMPTED TO REMOVE IT FROM THE REST OF THE ASSEMBLY, PER PROCEDURE. WHEN THE USAGE OF THE DEVICE FAILED, THE OPERATOR REMOVED AND REPLACED THE LINE WITH A TELEFLEX ARROW CENTRAL VENOUS CATHETER SET. THE DIFFICULTIES WITH CATHETER SETS REPORTEDLY OCCUR USUALLY IN DIFFICULT CASES, BUT HAVE BEEN ALSO OCCURRED REGARDLESS OF PROCEDURE DIFFICULTY AND THE SKILL OF THE OPERATOR. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS PENDING. THE SPECIFIC CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6878363 ↗
• MalfunctionAug 8, 2017Unraveled Material; Unraveled Material

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER FOR AN UNSPECIFIED INDICATION. THE CENTRAL VENOUS CATHETER WAS INSERTED SUCCESSFULLY INTO THE RIGHT INTERNAL JUGULAR VEIN OF THE PATIENT OVER THE GUIDEWIRE IN AN INTERMIDIATE STAGE OF THE PROCEDURE. THE GUIDE WIRE KINKED AND UNCOILED WHEN THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE ASSEMBLY AT THE TERMINATION OF THE PROCEDURE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6773555 ↗