Situate G0404-32P01CN-1Recalls & reported problems
Covidien LP · Gauze-RF and X-ray Detectable USP Type VII, 32 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
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521700826), received between Jun 3, 2019 and Feb 21, 2024 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 Component4
- Material Fragmentation3
- Material Frayed1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER ISSUE, DURING PROCEDURE, THE GAUZE WAS FRAYING. CUSTOMER STATED THE GAUZE THAT WAS IN THE BASIC PACK WAS SHREDDING WHEN THE STAFF USED IT ON PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18753771 ↗MalfunctionJan 16, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, THE GAUZE WAS FLAKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18519005 ↗InjuryMar 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE RFID FELL OUT AND INTO THE PATIENT, WAS ABLE TO RETRIEVED THE BROKEN PIECE.
Patient problems: Insufficient Information
MAUDE report 16499434 ↗MalfunctionSep 24, 2021Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, PRIOR TO USE, THE GAUZE WAS FALLING APART. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12525553 ↗MalfunctionMar 30, 2021Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE X-RAY GAUZE FRAYING APART AND BLUE X-RAY BAND FALLING OUT. PHOTO SUBMITTED SHOWING GAUZE JUST FRAYING AND BLUE STRING WAS DETACHED.
Patient problems: Insufficient Information
MAUDE report 11587112 ↗MalfunctionJul 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THEY FOUND TINY FIBERS IN RAYTEC GAUZE. THE FIBERS WERE DETERMINED TO BE PART OF THE GAUZE. A PICTURE WAS SUBMITTED WHICH SHOWED AN AUTOLOGOUS BONE WITH TINY FIBERS ATTACHED TO THEM. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10317766 ↗MalfunctionJun 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE GAUZE RADIO FREQUENCY CHIP WAS NOT PROPERLY SEWN INTO THE GAUZE AND FELL OUT. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8661587 ↗
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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