CureWrap™ Pediatric 122–135cm (single) 500-03548Recalls & 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
- 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 07290012127380), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (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. 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
- Device Handling Problem1
- Device-Device Incompatibility1
- Leak/Splash1
- Material Puncture/Hole1
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.
MalfunctionJun 27, 2024Leak/Splash; Material Puncture/Hole; Device-Device Incompatibility; Device Handling Problem; Leak/Splash; Material Puncture/Hole; Device-Device Incompatibility; Device Handling Problem
THE USER FACILITY IN UK REPORTED THAT PATIENT BEING ACTIVELY COOLED FOR NEUROPROTECTION. PATIENT PLACED ON CRITICOOL COOLING MATTRESS, CONNECTED TO MACHINE AND COOLING COMMENCED. LARGE AMOUNT OF LEAKING FROM COOLING MATTRESS NOTED COVERING BED AND PATIENT. COOLING MACHINE STOPPED, COOLING MATTRESS REMOVED AND PATIENT CHANGED. NEW COOLING MATTRESS PUT UNDER PATIENT AND COOLING RESTARTED. NO HARM TO PATIENT. HOLE NOTED AT TOP OF COOLING MATTRESS. CRITICOOL LOT NUMBER M223561 3548 PICU TECHS AND PICU STORES NURSING LEAD AWARE AND MONITORING MACHINE AND COOLING USE FOR ANY FURTHER ISSUES. MANUFACTURER ALREADY INVOLVED AS PREVIOUS ISSUES WITH COOLING MATTRESS LEAKS. MANUFACTURER UPDATED ABOUT RECENT INCIDENT. ON INVESTIGATION -ARTERIAL TRANSDUCER CLIP WAS FOUND TO HAVE BEEN ATTACHED TO THE COOLING MATTRESS AND THE HOLE FOUND WAS NEXT TO WHERE THE TRANSDUCER HAD BEEN ATTACHED TO COOLING MATTRESS. THIS COULD HAVE BEEN THE CAUSE OF THE HOLE IN THE MATTRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19624004 ↗
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
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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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