Rapr-Round 8001-061-530Recalls & reported problems
Stryker Corporation · Class 2
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 07613327175080), received between Oct 29, 2018 and Oct 29, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Cooling” (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
- Insufficient Cooling1
Patient problems
- Alteration In Body Temperature1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2018Insufficient Cooling
THE FOLLOWING WAS REPORTED BY USER FACILITY MEDWATCH (B)(4): PATIENT IS ADMITTED POST CARDIAC ARREST. THE MD ORDERED HYPOTHERMIA PROTOCOL TO BE APPLIED. OBTAINED COOLING WRAPS/BLANKET WITH A GOAL TEMP OF 36. COOLING BLANKET STATES IT IS COOLING PATIENT WITH A WATER TEMPERATURE OF 27. COOLING BLANKET FEELS AS THOUGH IT IS ROOM TEMPERATURE, AND THE PATIENT'S TEMPERATURE CONTINUED TO RISE.
Patient problems: Alteration In Body Temperature
MAUDE report 8016222 ↗
Other System, thermal regulating devices
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- Arctic Sun® 5000 50000000EMedivance, Inc. · System, thermal regulating1 recall2 deaths4,413 reports
- Arctic Sun Stat 60000000Medivance, Inc. · System, thermal regulating1 recall1,613 reports
- Arctic Sun® 5000 50000000LMedivance, Inc. · System, thermal regulating1 recall388 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31802Medivance, Inc. · System, thermal regulating1 recall385 reports
- Altrix 8001Stryker Corporation · System, thermal regulating1 recall160 reports
- Arctic Sun Stat 60000000LMedivance, Inc. · System, thermal regulating1 recall104 reports
- HotDog Temperature Management System WC77Augustine 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 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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