CARDINAL HEALTH PVCGOHCOBRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439839852), received between Nov 18, 2020 and May 17, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (2 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 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.

• MalfunctionMay 17, 2021Material Separation; Material Separation

  DURING ROOM SET UP FOR AN OPEN HEART PROCEDURE, THE CLINICIANS OPENED THE PACK AND SAW LINTING ON THE BLUE TOWELS PWTB04-STM FROM THE OPEN HEART KIT PVCGOHCOB SO REFUSED TO USE THE WHOLE PACK. THERE WAS NO DELAY OR INJURY TO THE PATIENT. REPORT BEING FILED FOR RISK TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838414 ↗
• MalfunctionMay 12, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED LINT ON THE BLUE TOWELS PWTB04-STM FROM OPEN HEART KIT, PVCGOHCOB. LINT WAS FOUND PRIOR TO PROCEDURE WITH NO DELAY OR AFFECT TO PATIENT. NO CLINICAL DATA OR PATIENT DEMOGRAPHICS WERE PROVIDED AFTER NUMEROUS ATTEMPTS TO OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812099 ↗
• MalfunctionNov 18, 2020Material Frayed

  BASED ON INFORMATION RECEIVED BY THE CUSTOMER, THE RAYTEC SPONGES IN THE CUSTOM PACK ARE REPORTEDLY FRAYING AND THE SPONGES CANNOT BE USED.

  Patient problems: Insufficient Information

  MAUDE report 10861492 ↗