ThermoWrap™ Universal 135-152cm, (single) 500-03153Recalls & reported problems
Belmont Instrument Corporation · Accessory for the Allon 2001 system. A body wrap connected to the thermoregulation system. · 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 07290012127243), received between Jun 5, 2025 and Jun 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (K024128); they may or may not involve this specific model.
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
- Insufficient Device Problem Information1
Patient problems
- Blister1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT, "PHYSICAL EXAMINATION REVEALS DEEP MARKS AND EARLY-STAGE SKIN LESIONS ON THE PATIENT'S BACK AT THE CONTACT AREAS WITH THE THERMAL COVER, WHICH HAD BEEN APPLIED ACCORDING TO THE GUIDELINES PROVIDED DURING STAFF TRAINING. AFTER REPOSITIONING THE COVER ONTO THE PATIENT'S CHEST, THE WEIGHT OF THE WATER-FILLED DEVICE CAUSED SIMILAR MARKS".
Patient problems: Blister
MAUDE report 22153684 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K024128. One submission often covers many models, so check the product and lot details in each record.
- Z-1966-2025 · May 13, 2025 · Open, ClassifiedAllon 2001. Part Number: 200-00263
Other System, Thermal Regulating devices
- Arctic Sun® 5000 50000000Medivance, Inc. · System, thermal regulating1 recall3 deaths6,903 reports
- 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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