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Vistec 7463Recalls & reported problems

Cardinal Health, Inc. · X-Ray Detectable Sponges,16 Ply · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884527017089), received between Oct 15, 2021 and Oct 25, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Component Missing2

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 25, 2022Component Missing; Component Missing

    CUSTOMER REPORTED THAT THE GAUZE SPONGE 8X4 16PLY 10'S XR CONTAINED 12 PIECES OF GAUZE INSTEAD OF 10.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15666446 ↗
  • MalfunctionOct 15, 2021Component Missing; Component Missing

    THE PACKAGE HAS HAS 8 INSTEAD OF 10 RAYTEC GAUZE SPONGES.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12640691 ↗

Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices

All GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.