TRITON GAUS-2Recalls & reported problems
Stryker Corporation · TRITON CANISTER · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00859506006029), received between Aug 29, 2024 and Sep 25, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “High Readings” (4 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jan 25, 2023Open, Classified
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Z-1186-2023 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- High Readings4
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2024High Readings; High Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305511 ↗MalfunctionSep 25, 2024High Readings; High Readings
DURING A PROCEDURE WITH HEMORRHAGING, THE QUANTITATIVE BLOOD LOSS WAS SIGNIFICANTLY LOWER THAN THE ESTIMATED BLOOD LOSS ON THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305405 ↗MalfunctionSep 25, 2024High Readings; High Readings
DURING A PROCEDURE WITH HEMORRHAGING, THE QUANTITATIVE BLOOD LOSS WAS SIGNIFICANTLY LOWER THAN THE ESTIMATED BLOOD LOSS ON THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305214 ↗MalfunctionSep 5, 2024High Readings; High Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146253 ↗MalfunctionAug 29, 2024Low Readings; Low Readings
PER THE ACCOUNT, THE TRITON CANISTER SOFTWARE GAVE A LOW ESTIMATED BLOOD LOSS READING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20095515 ↗
Other Image Processing Device For Estimation Of External Blood Loss devices
- Triton Canister System FG-12009Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss2 recalls0 reports
- TRITON FG-12010Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss2 recalls0 reports
- TRITON GAUS-3Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss1 recall0 reports
- Triton 0894000001Stryker Corporation · Image processing device for estimation of external blood loss3 reports
- TRITON FG-12022Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss1 report
- N/A 0894000004Stryker Corporation · Image processing device for estimation of external blood loss1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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