CARDINAL HEALTH PVCGOHCOARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439637335), received between Apr 28, 2020 and Feb 9, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2021Material Separation; Material Separation

  CUSTOMER REPORTED LINT PARTICLES WERE FOUND ON SURGEON¿S HANDS WHILE DRYING HANDS WITH BLUE TOWEL PWTB04-STM FROM THE OPEN HEART KIT PVCGOHCOB. NO CLINICAL DATA OR PATIENT DEMOGRAPHICS WERE PROVIDED BY CUSTOMER WHEN REQUESTED. REPORT FILED FOR POTENTIAL RISK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11303513 ↗
• MalfunctionJul 30, 2020Material Fragmentation

  CUSTOMER REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT, THE OR TOWELS PWTB04-STM FROM THE OPEN HEART KIT PVCGOHCOA WERE FRAYING, CAUSING FIBERS TO BE LEFT ON GLOVES AND INSTRUMENTS. THE FRAYING MATERIAL WAS WIPED OFF INSTRUMENTS AND STAFF HAD TO CHANGE GLOVES DURING PROCEDURE. NO INJURY REPORTED. NO PATIENT DEMOGRAPHICS OR EVENT DATE PROVIDED. REPORT BEING FILED FOR POTENTIAL RISK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347529 ↗
• MalfunctionApr 28, 2020Defective Device

  CUSTOMER REPORTED STERILE TOWEL INSIDE OF HEART PACK WAS DEFECTIVE. THE SCRUB NURSE'S GLOVES WERE COVERED IN LINT FROM THE TOWEL NOT REMAINING INTACT. NO ADDITIONAL INFORMATION WAS RECEIVED. CARDINAL HEALTH IS FILING A REPORT FOR POTENTIAL RISK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10007756 ↗