CARDINAL HEALTH SCVHFPPSHDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439513899), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 27, 2020Material Fragmentation

  CUSTOMER REPORTED LINTING OF THE BLUE OR TOWELS PWTB04-STM FROM THE PACEMAKER PACK SCVHFPPSHD. LINT WAS FOUND ON EQUIPMENT AND GLOVES DURING THE PACEMAKER CASE. TOWELS WERE REMOVED FROM CASE AND THERE WAS NO INJURY TO THE PATIENT. THE CUSTOMER PROVIDED NO FURTHER INFORMATION OR DATA AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765203 ↗