CARDINAL HEALTH SCV21OPHVARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439690965), received between Feb 10, 2021 and Feb 10, 2021 — classified as 1 malfunction.

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

• MalfunctionFeb 10, 2021Material Frayed; Material Frayed

  CARDIO-VASCULAR SURGEON WAS UPSET ABOUT THE OR TOWELS (PWTB04-STM) IN NEW OPEN HEART PACKS (SCV21OPHVA). HE REPORTED THAT THE TOWELS WERE UNACCEPTABLE AS THEY HAD AN EXCESSIVE AMOUNT OF LINT. THE LINT WAS FOUND ON TOWELS, INSTRUMENTS, PATIENT, SCRUB PERSONNEL, ON DOCTOR HANDS, AND SURGEONS GLOVES, AS WELL AS, IN THE AORTIC LEAFLETS. THERE WAS NO PATIENT INJURY. NO PATIENT DEMOGRAPHICS PROVIDED UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310969 ↗