Cook G05948Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002059481), received between Jun 6, 2017 and Feb 20, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE INTERNATIONAL CUSTOMER REPORTED THAT, IN ORDER FOR THE SINGLE LUMEN DISTAL AORTIC PRESSURE MONITORING SET TO WORK CORRECTLY, "ADDITIONAL TRACTION" [SIC] HAD TO BE ADDED. THE BEDSIDE NURSE QUESTIONED THE ACCURACY OF THE ARTERIAL LINE BLOOD PRESSURE. NO ADVERSE EVENTS WERE REPORTED BY THE CUSTOMER. ACCORDING TO THE FORM PROVIDED BY THE CUSTOMER, "PRODUCT REACHED PATIENT; NO APPARENT HARM; PROBABLY INCONVENIENT FOR PATIENT AND/OR STAFF." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. IT IS UNKNOWN IS THE DEVICE IS AVAILABLE FOR RETURN; 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 7283397 ↗
• InjuryJun 6, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT HAD A SINGLE LUMEN DISTAL AORTIC PRESSURE MONITORING CATHETER IMPLANTED ON AN UNKNOWN DATE. THE CUSTOMER REPORTS THAT THE ARTERIAL LINE SITE APPEARED TO BE BLEEDING. UPON CLOSER INSPECTION, THE ARTERIAL LINE CATHETER WAS CRACKED ON BOTH SIDES OF THE HUB JUST DISTAL TO THE PATIENT INSERTION SITE. THE SUBJECT LINE WAS EXPLANTED AND REPLACED. THE CUSTOMER REPORTED A SECOND OCCURRENCE (MDR # 1820334-2017-01471) WITH THE SAME PATIENT WITHIN 24 HOURS OF THE REPLACEMENT. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. A DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED; NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 6613977 ↗