Cook G01909Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002019096), received between Dec 23, 2016 and Jul 14, 2021 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2021Material Frayed; Unraveled Material; Material Frayed; Unraveled Material

  ADDITIONAL INFORMATION WAS PROVIDED ON 26AUG2021. IT WAS REPORTED THAT THE PATIENT REQUIRED THE DEVICE TO MONITOR FEMORAL BLOOD PRESSURE. A FEMORAL PUNCTURE WAS SELECTED AS "IT WAS NOT POSSIBLE TO MONITOR BLOOD PRESSURE THROUGH ARTERIAL PUNCTURE DUE TO THE DEGREE OF OBESITY OF THE PATIENT". THE PATIENT WAS BEDRIDDEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168148 ↗
• MalfunctionApr 1, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE DEVICE WAS PLACED FOR INVASIVE MEAN ARTERIAL PRESSURE MONITORING IN THE RIGHT FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605200 ↗
• MalfunctionFeb 26, 2021Unraveled 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 11385656 ↗
• MalfunctionFeb 17, 2020Unraveled Material; Unraveled Material

  IN ADDITIONAL INFORMATION RECEIVED ON 27FEB2020, IT WAS REPORTED THAT THE DAMAGE TO THE WIRE WAS NOTICED AFTER IT WAS REMOVED FROM THE HOLDER. THERE WAS NO DIFFICULTY EXPERIENCED WHEN REMOVING THE WIRE GUIDE FROM THE HOLDER.

  Patient problems: No Patient Involvement

  MAUDE report 9716423 ↗
• MalfunctionOct 31, 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 9260038 ↗
• MalfunctionOct 17, 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 9204846 ↗
• MalfunctionDec 17, 2018Break; Stretched

  IT WAS REPORTED THAT FEMORAL ARTERY PRESSURE CATHETER SET WIRE GUIDE FELL APART DURING THE WITHDRAWAL. IT WAS FURTHER NOTED THAT THE GUIDE WIRE WAS ELONGATED AND STRETCHED. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171852 ↗
• MalfunctionJun 8, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED DURING A QUALITY INSPECTION AT A DISTRIBUTION CENTER, ONE FEMORAL ARTERY PRESSURE MONITORING SET CONTAINED AN UNIDENTIFIED PARTICLE INSIDE ITS PRIMARY PACKAGING. AS REPORTED, THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7582800 ↗
• MalfunctionMay 14, 2018Break

  PHYSICIAN ATTEMPTED TO PLACE FEMORAL ARTERIAL LINE IN LEFT GROIN. WHILE ATTEMPTING, THE GUIDE WIRE BROKE AND A PARTIAL TIP WAS LEFT IN THE TISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7510949 ↗
• MalfunctionAug 3, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  INTERNATIONAL CUSTOMER REPORTED UNIDENTIFIED FOREIGN MATTER WAS OBSERVED WITHIN THE DEVICE PRIMARY PACKAGE. THE EVENT WAS OBSERVED DURING INCOMING PRODUCT INSPECTION AT THE DISTRIBUTION CENTER. THERE ARE NO PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 6764041 ↗
• InjuryDec 23, 2016Material Disintegration; Material Disintegration

  IT WAS REPORTED A PATIENT REQUIRED PUNCTURE OF THE RIGHT FEMORAL ARTERY UNDER SELDINGER'S TECHNIQUE FOR THE INSTALLATION OF INVASIVE BLOOD PRESSURE. THE GUIDEWIRE WAS PASSED AND THE CATHETER WAS PLACED. THE GUIDEWIRE WAS REMOVED, IT CAME OUT DISINTEGRATING, PREVENTING THE COMPLETE REMOVAL OF THE GUIDEWIRE, NECESSITATING REMOVAL OF THE ENTIRE CATHETER. THE GUIDE WIRE WAS REPORTED TO BE TWICE AS LARGE AS ITS ORIGINAL SIZE. A NEW KIT WAS USED TO COMPLETE PLACEMENT OF THE CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6202396 ↗