Situate G0804-16P02C-1Recalls & reported problems
Covidien LP · Gauze - RF and X-ray Detectable USP Type VII, 16 Ply · Class 1
All models of Situate (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521700857), received between Jul 1, 2019 and Mar 30, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Fragmentation2
- Detachment of Device or Device Component1
Patient problems
- No Patient Involvement2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2020Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THERE WAS LINTING NOTICED OF GAUZE UPON OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9896276 ↗MalfunctionFeb 12, 2020Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, BASED ON THE PICTURE PROVIDED THE COTTON FIBER MATERIALS WAS COMING OFF. THERE WAS NO PATIENT INVOLVED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9703201 ↗InjuryJul 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A TOTAL HIP SURGERY, THE DOCTOR PLACED THE ITEM IN THE FEMORAL CANAL, WHEN IT WAS REMOVED, HE DROPPED IT INTO THE KICK BUCKET. THE CIRCULATOR OPENED THE ITEM AND FOUND THAT THE RF DEVICE THAT IS SUPPOSED TO BE IMBEDDED ON IT WAS DAMAGED AND PART OF IT WAS MISSING. THEY WASHED OUT THE FEMORAL CANAL THOROUGHLY. THE PART THAT WAS MISSING IS THE PLASTIC TIP OFF OF ONE END. THERE WAS NO X-RAY DONE. THE DOCTOR STATED THAT IT WAS UNRESOLVABLE AND WASHING OUT IS THE BEST THEY CAN DO.
Patient problems: No Information
MAUDE report 8749443 ↗
Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices
- Vistec 7317Cardinal Health, Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall80 reports
- Situate G0804-12P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE120 reports
- Situate G0404-16P01CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE114 reports
- Situate G0804-16P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 recalls1 report
- Situate L1818-04P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall20 reports
- Situate G0404-16P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE60 reports
- Arterial Line Kit 400115AArgon Medical Devices, Inc. · Gauze/Sponge, Internal, X-Ray Detectable1 recall0 reports
- AMD-RITMED 55992CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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