Cook G01908Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002019089), received between Oct 19, 2017 and Aug 19, 2021 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A RADIAL ARTERY PRESSURE MONITORING SET BROKE WHILE IN THE PATIENT. THE PATIENT LATER EXPIRED. ADDITIONAL INFORMATION REGARDING EVENT AND PATIENT DEATH DETAILS HAVE BEEN REQUESTED, BUT ARE CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12346081 ↗
• MalfunctionAug 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A RADIAL ARTERY PRESSURE MONITORING SET BROKE PRIOR TO PLACING IN THE PATIENT. ADDITIONAL INFORMATION REGARDING EVENT AND PATIENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346037 ↗
• InjuryApr 19, 2021Material Separation; Material Separation

  IN ADDITIONAL INFORMATION RECEIVED ON 21APR2021, IT WAS REPORTED THAT THE PATIENT IS "DOING OK" AFTER BESIDE REMOVAL BY THE VASCULAR SURGEON.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11684761 ↗
• MalfunctionOct 18, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

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

  Patient problems: No Patient Involvement

  MAUDE report 9208776 ↗
• DeathJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT INCLUDED IN A TRIAL PASSED AWAY. A COOK INC. RADIAL ARTERY PRESSURE MONITORING SET WAS BEING USED IN THE RIGHT RADIAL. THERE WAS NO CAUSE OF DEATH PROVIDED. THERE WAS NO COMPLAINT OF ANY DEVICE MALFUNCTION. THERE WAS NO INFORMATION PROVIDED SUGGESTING THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. ADDITIONAL QUESTIONS HAVE BEEN ASKED REGARDING THE FOLLOWING AND TO DATE THERE HAS BEEN NO INFORMATION PROVIDED. PLEASE PROVIDE CAUSE OF PATIENT DEATH? DID THE COMPLAINT DEVICE CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT? WHAT WAS THE DEVICE BEING USED FOR DURING THE PROCEDURE? PLEASE PROVIDE AUTOPSY OR PATHOLOGY REPORTS IF AVAILABLE? PLEASE PROVIDE THE PATIENT'S CONDITION AT THE TIME OF DEVICE PLACEMENT? PLEASE PROVIDE ANY PROCEDURAL IMAGING IF AVAILABLE? PLEASE PROVIDE PATIENT DEMOGRAPHICS. PLEASE PROVIDE PATIENT PRE-EXISTING CONDITIONS. (PLEASE PROVIDE ANY PATIENT PRE-DISPOSITIONS). PLEASE PROVIDE ANY IMAGES OR VIDEOS OF COMPLAINT DEVICE IF AVAILABLE?

  Patient problems: Death

  MAUDE report 7728771 ↗
• MalfunctionDec 6, 2017Difficult to Flush; Unable to Obtain Readings; Difficult to Flush; Unable to Obtain Readings

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE RADIAL ARTERY PRESSURE MONITORING SET WAS EMPLOYED, THE WAVEFORM DAMPENED IMMEDIATELY FOLLOWING INSERTION. FLUSHING AND WRIST REPOSITIONING IMPROVED THE SIGNAL, BUT 48 HOURS POST INSERTION, THE WAVEFORM WAS ULTIMATELY COMPLETELY ABSENT, AND FLUSHING WAS DIFFICULT. THE BLOOD DRAW HAD BECOME SLOW, AND SIGNIFICANT PRESSURE WAS REQUIRED AT THE INSERTION SITE. THE WAVEFORM WAS AGAIN ABSENT AT THE 54 HOUR POST INSERTION. FLUSHING AND BLOOD DRAW BECAME IMPOSSIBLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT HAS NOT YET BEEN PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN AND INVESTIGATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088670 ↗
• MalfunctionDec 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT THE ARTERIAL LINE OF THE RADIAL ARTERY PRESSURE MONITORING SET WAS NOT DRAWING BLOOD 1.5 HOURS FOLLOWING THE INSERTION OF THE DEVICE. THE CUSTOMER HAS CONFIRMED THAT NO APPARENT PATIENT HARM HAS OCCURRED. ADDITIONAL INFORMATION REGARDING THE INSTANCE OF PRODUCT MALFUNCTION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7081699 ↗
• MalfunctionOct 19, 2017Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE ARTERIAL LINES IN THE RADIAL ARTERY PRESSURE MONITORING SET CLOTTED. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICES LEADING UP TO THE REPORTED CLOTTING WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6960858 ↗