CARDINAL HEALTH SCVOCCTSRGRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887488768809), received between Oct 8, 2019 and Mar 9, 2020 — classified as 2 malfunctions.

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

• MalfunctionMar 9, 2020Material Fragmentation

  THE CUSTOMER REPORTED TO CARDINAL HEALTH THAT DURING A PEDIATRIC CARDIAC CATHETERIZATION, LINT FROM THE BLUE OR TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK/ SCVOCCTSRG WAS FOUND ON THE WIRES AND IN THE SALINE BOWL. THERE WAS NO INJURY TO THE PATIENT AND NO IMPACT POST-PROCEDURE. NO PATIENT DEMOGRAPHICS OR EVENT DATE WERE PROVIDED AFTER ATTEMPTS TO OBTAIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9808676 ↗
• MalfunctionOct 8, 2019Contamination /Decontamination Problem

  THE CUSTOMER STATED THAT THE BLUE,COTTON, NON-X-RAY TOWELS, COMPONENT PWTB03-STMA FROM CATALOG SCVOCCTSRG /CARDIAC CATHETERIZATION PACK, WERE LINTING. THE PHYSICIAN USED THE DRY TOWEL TO REST HIS WIRES ON (NOT WIPING THE WIRES) AND NOTICED THAT WHEN HE WENT TO USE THE WIRE THERE WAS LINT FROM THE BLUE TOWEL ADHERING TO THE WIRE. NO INJURY WAS REPORTED. NO PATIENT DEMOGRAPHICS OR DATE OF EVENT WERE PROVIDED. MDR BEING FILED FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9168723 ↗