Cook G02930Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002029309), received between Jan 17, 2018 and Jan 17, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2018Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  THE CUSTOMER REPORTED THAT, UPON THE ATTEMPTED REMOVAL FROM THE PATIENT OF THE RADIAL ARTERY PRESSURE MONITORING SET CATHETER, THE DEVICE BECAME LODGED IN THE PATIENT, AND ADDITIONAL SURGERY WAS REQUIRED TO REMOVE THE LODGED PORTION. THE LODGED PORTION WAS ULTIMATELY REMOVED SUCCESSFULLY. A VOLUNTARY MEDWATCH REPORT (MW5074233) WAS RECEIVED ON (B)(6) 2018. THE REPORT STATED, "WHEN REMOVING THE CATHETER, A PORTION BROKE OFF AND WAS RETAINED AND REQUIRED SURGICAL INTERVENTION FOR REMOVAL. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7202091 ↗