Cook G51533Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002515338), received between Sep 27, 2017 and Sep 4, 2024 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Break; Break

  IT WAS REPORTED THAT THE WIRE GUIDE FROM A FIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET SEPARATED. DURING REMOVAL OF THE SECOND DILATOR, THE WIRE GUIDE WAS CUT AND SUBSEQUENTLY SEPARATED. TEN CENTIMETERS OF THE WIRE WAS REMOVED FROM THE PATIENT, AND THE REMAINDER WAS RETAINED IN THE INTRAMUSCULAR. AS A RESULT, THE PATIENT REQUIRED IMAGING AND DEVICE REMOVAL IN THE PAVILION. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20141078 ↗
• MalfunctionMar 11, 2024Break; Material Separation; Break; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED STATING THE WIRE WAS MANIPULATED THROUGH THE NEEDLE. THE PHYSICIAN INDICATED THAT THE WIRE GUIDE MANDRIL BROKE DURING THE DILATION PROCESS WHEN THE DILATOR PASSED OVER THE GUIDE. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT DURING THE INITIAL PLACEMENT PROCEDURE. IT IS UNKNOWN IF THE PATIENT HAD TORTUOUS ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18878183 ↗
• InjuryMar 11, 2024Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient

  MAUDE report 18878062 ↗
• MalfunctionNov 6, 2020Unraveled Material; Unraveled Material

  IN ADDITIONAL INFORMATION RECEIVED ON 24NOV2020, IT WAS REPORTED THAT THE NEEDLE WAS NOT WITHDRAWN THROUGH THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10802178 ↗
• MalfunctionNov 6, 2020Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE WIRE GUIDE DURING INSERTION OF A FIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER ON (B)(6) 2020. UPON REMOVAL OF THE WIRE GUIDE, IT WAS FOUND TO BE BROKEN. A MALE PATIENT WAS ADMITTED TO THE ADULT CRITICAL PATIENT UNIT FOR ACUTE RESPIRATORY FAILURE ASSOCIATED WITH COVID-19, AND WAS REPORTED TO BE IN RESPIRATORY ISOLATION. THE INDICATION FOR PLACEMENT WAS ADMINISTRATION OF MEDICATION, HEMODERIVATIVES, AND OTHER TREATMENT. A PUNCTURE WAS MADE IN THE SUBCLAVIAN VEIN UNDER "STERILE TECHNIQUE". THE GUIDE WIRE WAS INSERTED AND AFTER DILATION, AND ATTEMPT WAS MADE TO INSERT THE CATHETER. THERE WAS DIFFICULTY EXPERIENCED INSERTING THE CATHETER, AND AT THIS POINT, THE WIRE GUIDE WAS REMOVED AND FOUND TO BE UNRAVELED. DUE TO THE POSSIBLE RISK OF INJURING THE PATIENT WITH THE BROKEN WIRE GUIDE, THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. A DIFFERENT MANUFACTURER'S CATHETER WAS USED AT A DIFFERENT PUNCTURE SITE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10802109 ↗
• MalfunctionJul 20, 2020Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS PROVIDED ON 31JUL2020. THE GUIDE WIRE WAS FOUND TO BE DAMAGED BEFORE THE DEVICE WAS TO BE PLACED IN THE LEFT SUBCLAVIAN VEIN. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10297863 ↗
• InjuryJul 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE WIRE GUIDE OF A FIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET BROKE. NO ADVERSE EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10297673 ↗
• InjuryJul 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE WIRE GUIDE OF A FIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET SEPARATED AND THE DISTAL PORTION OF THE WIRE MIGRATED TO THE PATIENT'S HEART. THE PATIENT HAD TO HAVE AN ADDITIONAL PROCEDURE TO REMOVE THE PORTION OF THE WIRE THAT MIGRATED TO THEIR HEART. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10296253 ↗
• MalfunctionSep 27, 2017Break; Out-Of-Box Failure

  WHEN THE PHYSICIAN WAS OPENING THE PACKAGE, HE OBSERVED THAT THE CATHETER WAS BROKEN, AND THIS OCCURRED WITH FOUR DIFFERENT LOT NUMBERS. THE PHYSICIAN MANAGED TO USE A FIFITH PRODUCT TO FINISH THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT OR ADDITIONAL PROCEDURES HAVE BEEN REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6896941 ↗
• MalfunctionSep 27, 2017Break

  WHEN THE PHYSICIAN WAS OPENING THE PACKAGE, HE OBSERVED THAT THE CATHETER WAS BROKEN, AND THIS OCCURRED WITH FOUR DIFFERENT LOT NUMBERS. THE PHYSICIAN MANAGED TO USE A FIFTH PRODUCT TO FINISH THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT OR ADDITIONAL PROCEDURES HAVE BEEN REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6896740 ↗