CARDINAL HEALTH SCV13PCCAARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439470765), received between Jan 9, 2020 and Jan 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• MalfunctionJan 9, 2020Material Fragmentation; Material Frayed; Device Damaged Prior to Use

  CUSTOMER REPORTED THE SPONGE EDGES APPEAR CRUMBLY AND ARE FRAYED. REPORTEDLY, FRAGMENTS OF THE SPONGE WERE NOTED WITHIN THE PACK WHEN OPENED ON THE TABLE BEFORE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9572354 ↗