ENDO-FUSE 500001010Recalls & reported problems
Wright Medical Technology, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889797031639), received between May 10, 2022 and May 10, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (1 report).
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
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2022Defective Component; Defective Component
IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS UNABLE TO FILL. THE DEVICE DISPLAYED THAT IT WAS FULL, BUT ACTUALLY IT WAS EMPTY. THE LEVEL SENSOR WAS EXCHANGED IN THE FIELD AND THAT CORRECTED THE SENSING ISSUE. THE ARCTIC SUN DEVICE HAD A CALIBRATION ERRORS 80 AND 81 AND WILL BE EVALUATED FURTHER AT THE DEPOT. PER SAMPLE EVALUATION, THE ARCTIC SUN DEVICE DRAINED WATER WAS VERY DIRTY AND SLIMY. THE CIRCULATION PUMP WAS TOO SLOW AND THE FILL TUBE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14346776 ↗
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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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