Situate G0804-12P02CN-1Recalls & reported problems
Covidien LP · Gauze-RF and X-ray Detectable USP Type VII, 12 Ply. Caution: For Manufacturing, Processing or Repacking. · Class 1
All models of Situate (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Situate X-ray detectable gauze sponge has 120 adverse event reports, with no injuries and no deaths. Most describe pieces of the sponge detaching, such as blue thread coming loose, and some describe fraying or linting. Some reports say material entered the surgical site. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 120
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10884521700840), received between Aug 28, 2018 and Nov 6, 2024 — classified as 120 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (106 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component106
- Material Fragmentation16
- Material Frayed2
Patient problems
- No Clinical Signs, Symptoms or Conditions113
- No Patient Involvement5
- No Consequences Or Impact To Patient3
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RAYTECS INCLUDED IN THE HEAD AND NECK PACKS HAD BEEN INCONSISTENT IN QUALITY. MORE SPECIFICALLY, THE BLUE COATED THREAD THAT WAS SPIRALED THROUGHOUT THE SPONGE APPEARED TO BE CHIPPED, CAUSING THE MATERIAL TO SEPARATE FROM THE SPONGE AND ENTER THE OPERATIVE SPACE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620739 ↗MalfunctionNov 5, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RAYTECS INCLUDED IN THE HEAD AND NECK PACKS HAD BEEN INCONSISTENT IN QUALITY. MORE SPECIFICALLY, THE BLUE COATED THREAD THAT WAS SPIRALED THROUGHOUT THE SPONGE APPEARED TO BE CHIPPED, CAUSING THE MATERIAL TO SEPARATE FROM THE SPONGE AND ENTER THE OPERATIVE SPACE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20612937 ↗MalfunctionApr 25, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, SPONGES ARE FLAKING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19181970 ↗MalfunctionFeb 27, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAMPLES RECEIVED WAS LINTING X-RAY GAUZE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18788774 ↗MalfunctionJan 26, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, GAUZE BLUE STRIPS WERE BREAKING UP/FELL APART. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18589990 ↗MalfunctionJan 26, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, GAUZE BLUE STRIPS WERE BREAKING UP/FELL APART. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18589973 ↗MalfunctionJan 26, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, BLUE PIECES FROM RAYTECS IN SURGICAL WOUND WAS FRAYING OFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18588308 ↗MalfunctionNov 28, 2022Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, GAUZE WAS SEVERELY LINTING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15872078 ↗MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE BLUE X-RAY FILAMENT WAS BREAKING OFF FROM THE GAUZE SPONGE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15740705 ↗MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE BLUE X-RAY FILAMENT WAS BREAKING OFF FROM THE GAUZE SPONGE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15740241 ↗MalfunctionSep 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15455517 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451121 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451107 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451068 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451043 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451040 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451039 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451027 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451011 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451010 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451001 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15450992 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15450896 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15450892 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BLUE STRIP ON GAUZE WAS FRAYING OFF AND COULD GO INTO PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15450889 ↗
Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices
- Vistec 7317Cardinal Health, Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall80 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
- Medical Action Industries 403Medical Action Industries 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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