Cook G58402Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002584020), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

1 other recall cover devices cleared under the same FDA submission (K180846); they may or may not involve this specific model.

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.

• MalfunctionFeb 13, 2025Component Missing

  STAFF IN THE SURGICAL ICU WENT TO GRAB A PEDIATRIC ARTERIAL PRESSURE MONITORING SET FOR ONE OF THEIR PATIENTS. IT WAS FOUND THAT THE PACKAGE WAS SEALED FROM THE MANUFACTURER, BUT THE SET WAS NOT IN THE PACKAGE. THERE IS NOTHING IN THE SET EXCEPT FOR A SYRINGE. OTHER PACKAGES OF THESE A-LINE SETS WERE ALSO FOUND TO BE EMPTY. IN ALL, THERE WERE 4 DIFFERENT LOT NUMBERS FOUND TO BE AFFECTED. CURRENTLY, THE HOSPITAL HAS NO ADDITIONAL PEDIATRIC A-LINE KITS ON HAND, SINCE THE ONES IN RESERVE WERE ALSO FOUND TO BE EMPTY. LOTS AFFECTED: 15898496 X, 15066560 X1, 15948531 X1, 15188336 X5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376257 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180846. One submission often covers many models, so check the product and lot details in each record.

• Z-1778-2026 · Mar 5, 2026 · Open, Classified
  COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419