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Situate L1818-04P01C-LRecalls & reported problems

Covidien LP · Laparotomy Sponge - RF and X-ray Detectable Pre-washed, No Loop · Class 1

All models of Situate (29)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521700963), received between Jul 2, 2019 and Jul 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOOPS AND RF TAG ON 2 OF THE SPONGES IN THE SAME PACK DISLODGED WHEN THEY WERE ABOUT TO PLACE THE COTTON TO THE PATIENT. THERE WAS NO PATIENT INJURY. THERE WAS NO FURTHER INFORMATION AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8753433 ↗

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

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Sources and updates

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