WarmTouch 5016000-RCRecalls & reported problems
Covidien LP · Convective Warming Unit Reconditioned · Class 2
Data updated Oct 13, 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 10884521190672), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Protective Measures Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Protective Measures Problem1
- Use of Device Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2020Use of Device Problem; Protective Measures Problem; Use of Device Problem; Protective Measures Problem
ACCORDING TO THE REPORTER, THE UNIT'S CURSOR WAS CONSTANTLY MOVING AND IT HAD AN OVERHEAT ALARM. THE FAILURE WAS ISOLATED TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9934404 ↗
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- Altrix 8001Stryker Corporation · System, thermal regulating1 recall160 reports
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- Hillrom powered by Augustine Surgical HD 2083516Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- 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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