CARDINAL HEALTH SOPCGCPLGARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439636680), received between Sep 14, 2021 and Sep 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2021Material Separation; Material Separation

  CUSTOMER REPORTED LINTING OF THE OR TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION LAB PACK SOPCGCPLGA DURING CARDIAC CATH/PERCUTANEOUS CORONARY INTERVENTION PROCEDURES. THE CUSTOMER COULD NOT PINPOINT THE NUMBER OF TIMES LINTING WAS FOUND DURING PROCEDURES. CUSTOMER CONFIRMED THERE WAS NO ADVERSE EFFECT OR INJURY TO ANY PATIENTS. NO PATIENT DEMOGRAPHICS OR FURTHER INFORMATION WAS PROVIDED WHEN REQUESTED. MDR IS BEING FILED FOR RISK TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470767 ↗