Cook SpectrumRecalls & reported problems across all models

We found 67 models of Cook Spectrum by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 226 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2014 and Feb 26, 2026 — classified as 73 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (35 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Cook Spectrum recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 5, 2026Open, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1789-2026 · Root cause: Incorrect or no expiration date · names 4 of these models · Recall details · FDA record ↗

2. 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 · names 24 of these models · Recall details · FDA record ↗

3. Mar 5, 2026Open, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1783-2026 · Root cause: Incorrect or no expiration date · names 5 of these models · Recall details · FDA record ↗

4. Mar 6, 2020Terminated

   The printed expiration dates are incorrect.

   Z-1566-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Cook Spectrum problems

Cook Spectrum models

67 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cook Spectrum G47829

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall81 reports
• Cook Spectrum G47825

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall21 reports
• Cook Spectrum G50817

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall16 reports
• Cook Spectrum G53599

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall10 reports
• Cook Spectrum G47827

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall8 reports
• Cook Spectrum G48053

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall4 reports
• Cook Spectrum G51539

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall4 reports
• Cook Spectrum G21053

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall2 reports
• Cook Spectrum G43995

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall2 reports
• Cook Spectrum G34914

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall1 report
• Cook Spectrum G43983

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall1 report
• Cook Spectrum G44806

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall1 report
• Cook Spectrum G51537

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall1 report
• Cook Spectrum G24752

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G24754

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G24765

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G24803

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G24809

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G24810

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G43984

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G43985

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G43986

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G43996

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G43997

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44005

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44006

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44007

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44008

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44431

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44432

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44800

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44807

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44809

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G56424

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• Cook Spectrum G44128

  Catheter,intravascular,therapeutic,short-term less than 30 days
  15 reports
• Cook Spectrum G43991

  Catheter,intravascular,therapeutic,short-term less than 30 days
  5 reports
• Cook Spectrum G23763

  Catheter,intravascular,therapeutic,short-term less than 30 days
  4 reports
• Cook Spectrum G24137

  Catheter,intravascular,therapeutic,short-term less than 30 days
  4 reports
• Cook Spectrum G53602

  Catheter,intravascular,therapeutic,short-term less than 30 days
  4 reports
• Cook Spectrum G35136

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• Cook Spectrum G43981

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• Cook Spectrum G44015

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• Cook Spectrum G44016

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• Cook Spectrum G50819

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• Cook Spectrum G43130

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• Cook Spectrum G44013

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• Cook Spectrum G44126

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• Cook Spectrum G49803

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• Cook Spectrum G10194

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G23655

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G36206

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• Cook Spectrum G36209

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• Cook Spectrum G43982

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G44433

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G47831

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G47832

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G47833

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G48059

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G49802

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G49804

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G51198

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• Cook Spectrum G51199

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• Cook Spectrum G53600

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G53601

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G56422

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G57005

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook Spectrum G57495

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 report

Recent Cook Spectrum adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryFeb 12, 2026Crack

  ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE PATIENT REQUIRED REMOVAL OF THE CENTRAL VENOUS CATHETER (CVC) AFTER THE LEAK WAS DISCOVERED. AFTER EVALUATING THE PATIENT POST REMOVAL, THE CARE TEAM DECIDED TO REPLACE THE CVC WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326218 ↗
• 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 ↗
• MalfunctionJan 26, 2026Crack

  IT WAS REPORTED THAT THE WHITE HUB OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS CRACKED. AFTER REPOSITIONING THE PATIENT, IT WAS NOTED THAT THE PATIENT'S GOWN WAS WET ON THE RIGHT FEMORAL SIDE, INITIALLY THOUGHT TO BE DUE TO SWEATING OR A POSSIBLE SPILL DURING THE TURNS. DURING PREPARATION FOR INTRAVENOUS MEDICATION ADMINISTRATION VIA THE CENTRAL VENOUS LINE, THE WHITE PORT WAS FLUSHED, RESULTING IN FLUID SPRAYING OUT. CLOSER INSPECTION REVEALED A CRACK IN THE PORT, WITH FLUID LEAKING. THE PORT WAS IMMEDIATELY CLAMPED, COVERED WITH A RED STOPPER, AND MARKED WITH AN ORANGE WARNING STICKER TO INDICATE IT SHOULD NOT BE USED. THE "ACNM AND ICU REGISTRAR" WERE NOTIFIED WHO ADVISED CLAMPING AND LABELING THE DEFECTIVE PORT AND CONTINUING USE OF THE UNAFFECTED PORTS. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182962 ↗
• 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 ↗
• MalfunctionNov 18, 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 23582150 ↗
• MalfunctionNov 18, 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 23582099 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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