Situate L0418-04P01C-1Recalls & reported problems
Covidien LP · Laparotomy Sponge - RF and X-ray Detectable Pre-washed · Class 1
All models of Situate (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10884521700925), received between Nov 9, 2021 and May 12, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING RIGHT SHOULDER REVERSED TOTAL ARTHROPLASTY, THE LAPAROTOMY SPONGE (RAYTEC) WAS PLACED IN PATIENT'S SHOULDER, SPONGE WAS ACCIDENTALLY NICKED, AND BATTERY FELL OUT OF SPONGE INTO SHOULDER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14380661 ↗MalfunctionNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ROBOTIC COLECTOMY, THE DEVICE'S RF TAG FELL OFF IN PATIENT AND IT WAS FULLY RETRIEVED. THE PROCEDURE WAS COMPLETED AS NORMAL AND NO X-RAY WAS DONE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783791 ↗
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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