CureWrap™ Pediatric 91-104cm, (single) 500-03536Recalls & reported problems
Belmont Instrument Corporation · Accessory for the CritiCool system. · 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 07290012127342), received between Jul 27, 2023 and Jan 27, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Material Split, Cut or Torn1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Fluid/Blood Leak; Product Quality Problem; Material Split, Cut or Torn
ON TWO SEPARATE OCCASIONS A CRITICOOL CUREWRAP BLANKET HAS SPLIT WHILST FILLED WITH WATER AND BEING USED FOR A PATIENT. THIS LED TO WATER WETTING THE BED AND STAFF NEEDING TO REPLACE THE BLANKET. UNFORTUNATELY, THE LOT NUMBER WAS NOT RECORDED NOR THE TWO AFFECTED BLANKETS KEPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192358 ↗MalfunctionJul 27, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS NOTICED DURING THE CARE OF A PATIENT ON PEDIATRIC ICU THAT THE COOLING WRAP WAS LEAKING. THE WRAP HAD BEEN IN USE FOR 32 HOURS. THE CUSTOMER REPORTED 4 SEPARATE OCCASIONS WHERE THESE WRAPS HAVE BEEN IDENTIFIED AS LEAKING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17410079 ↗
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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