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Curity 6522Recalls & reported problems

Cardinal Health, Inc. · X-Ray Detectable Laparotomy Sponges,Soft Pouch Pack · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884527020485), received between Dec 5, 2020 and Dec 5, 2020 — classified as 1 injury.

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

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 5, 2020Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED THAT WHEN USING LUMICELL DURING A LUMPECTOMY, THE DOCTOR NOTED MANY PARTICLES OF LINT THAT WOULD NOT BE VISIBLE TO THE NAKED EYE AND COULD ONLY BE ATTRIBUTED TO THE LAP SPONGES.

    Patient problems: Foreign Body In Patient

    MAUDE report 10953558 ↗

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.