CARDINAL HEALTH SCV22OH48KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439551808), received between May 11, 2020 and May 11, 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.

• MalfunctionMay 11, 2020Material Fragmentation

  CUSTOMER REPORTED LINTING OF THE BLUE, COTTON, NON-XRAY TOWELS PWTB04-STM FOUND PRIOR TO AN OPEN HEART PROCEDURE. THE TOWELS WERE THEN DISCARDED. THERE WAS NO DELAY, INJURY OR NEGATIVE OUTCOME TO THE PATIENT. THE EVENT DATE WAS UNKNOWN BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10044982 ↗
• MalfunctionMay 11, 2020Contamination /Decontamination Problem

  CUSTOMER REPORTED LINTING OF THE BLUE, COTTON, NON-XRAY TOWELS FOUND PRIOR TO AN OPEN HEART PROCEDURE. THE TOWELS WERE THEN DISCARDED. THERE WAS NO DELAY, INJURY OR NEGATIVE OUTCOME TO THE PATIENT. THE EVENT DATE WAS UNKNOWN BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10044626 ↗