CureWrap™ Adult Over 135 cm 500-03500Recalls & reported problems
Belmont Instrument Corporation · Accessory for the CritiCool system. A body wrap connected to the CritiCool. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290012127175), received between Apr 30, 2020 and Aug 17, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K083662); 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.
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE CUREWRAP WAS LEAKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10417687 ↗MalfunctionApr 30, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE USER FACILITY REPORTED THAT A CUREWRAP WAS LEAKING DURING A CASE.
Patient problems: No Information
MAUDE report 10014281 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083662. One submission often covers many models, so check the product and lot details in each record.
- Z-0153-2023 · Jul 20, 2021 · Open, ClassifiedCritiCool, thermoregulation device
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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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