CureWrap™ Infant (single)Recalls & reported problems
Belmont Instrument Corporation · Accessory for the CritiCool system. A body wrap connected to the CritiCool. · 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 07290107580625), received between Feb 4, 2026 and Feb 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Leak/Splash
I HAVE SUBMITTED A DATIX ABOUT A FAULTY COOLING WRAP THAT WAS FOUND TO BE LEAKING PLEASE SEE THE DATIX SUMMARY BELOW AND ATTACHED PHOTO, I HAVE THE FAULTY WRAP IN OUR OFFICE IF YOU WANT TO SEND IT BACK TO THE REP FOR FURTHER INVESTIGATION/REFUND? "WHEN HELPING A MEDIC TO HOLD A BABY FOR A NEW UAC INSERTION NOTICED THAT THE COOLING WRAP THE BABY WAS LYING ON FELT WET. UPON FURTHER EXAMINATION NOTICED THERE WAS QUITE A SIGNIFICANT POOL OF WATER UNDERNEATH THE BABY AND A LARGE PATCH OF WATER SURROUNDING THE BABY ON THE BEDSHEET. REMOVED THE COOLING WRAP AND SAW WATER DRIPPING OUT OF THE COOLING WRAP ITSELF, REMOVED AND REPLACED THE WRAP AND CHANGED ALL THE BEDSHEETS. UNFORTUNATELY THERE WAS NO STOCK OF THE 2.5-4KG WRAPS SO A LARGER 5-7KG HAD TO BE USED WHICH WAS TOO BIG FOR THE BABY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258241 ↗
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
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page