CureWrap™ Infant, 4-7Kg (single) 500-03521Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07290012127199), received between May 12, 2020 and Aug 4, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT, "COOLING BLANKET "POPPED" AND WATER DRAINED EVERYWHERE" DURING A CASE. THE PATIENT WAS NOT HARMED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22707195 ↗
• MalfunctionJun 1, 2023Device Handling Problem; Device Handling Problem

  THE DISTRIBUTOR REPORTED ON 04 MAY 2023 THAT A USER IN THE NETHERLANDS INDICATED THAT A PATIENT BEING TREATED WITH A CUREWRAP® GOT BURN MARKS ON THEIR ARM.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17042992 ↗
• MalfunctionJan 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER NOTICED LEAKING FROM CUREWRAP WHILE COOLING THE BABY FROM THE SAME LOT AS PREVIOUSLY REPORTED (B)(4). ANY REMAINING WRAPS FROM THE SAME LOT WERE REMOVED FORM THE AREA. THE PATIENT INVOLVED IN THE INCIDENT WAS NOT HARMED AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118914 ↗
• MalfunctionJan 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER NOTICED LEAKING FROM CUREWRAP WHILE COOLING THE BABY FROM THE SAME LOT AS PREVIOUSLY REPORTED M220761 .THE PATIENT INVOLVED IN THE INCIDENT WAS NOT HARMED AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118897 ↗
• MalfunctionJan 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER NOTICED LEAKING FROM CUREWRAP WHILE COOLING THE BABY FROM THE SAME LOT AS PREVIOUSLY REPORTED M222131 AND M220761 .THE PATIENT INVOLVED IN THE INCIDENT WAS NOT HARMED AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118882 ↗
• MalfunctionJan 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER NOTICED LEAKING FROM CUREWRAP WHILE COOLING THE BABY FROM THE SAME LOT AS PREVIOUSLY REPORTED (B)(4).THE PATIENT INVOLVED IN THE INCIDENT WAS NOT HARMED AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118871 ↗
• MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER NOTICED LEAKING FROM CUREWRAP WHILE COOLING THE BABY FROM THE SAME LOT AS PREVIOUSLY REPORTED (B)(4) .THE PATIENT INVOLVED IN THE INCIDENT WAS NOT HARMED AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118854 ↗
• MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER NOTICED LEAKING WRAPS WHILE COOLING THE BABY FROM THE SAME LOTS AS PREVIOUSLY REPORTED (M222131- TWO AFFECTED BLANKETS) (M220761 -ONE AFFECTED BLANKET).THE PATIENT INVOLVED IN THE INCIDENT WAS NOT HARMED AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118836 ↗
• MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER HAD TWO MORE INCIDENTS OF LEAKING CURE WRAPS. THE AFFECTED LOT# IS: M220761. 1ST INCIDENT ON (B)(6) 2022 BUT THE CURE WRAP WAS DISCARDED. 2ND INCIDENT ON (B)(6) 2022 AND THE CURE WRAP WAS SAVED TO BE ABLE TO RETURN FOR INVESTIGATION.THE PATIENTS WERE NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118812 ↗
• MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER DETAILED THE INCIDENT OCCURRED 11/15. THE USER NOTICED LINENS SOAKED WITH WATER AND THERE WAS WATER ON THE FLOOR. THEY DETAILED NO IMPACT TO PATIENT SINCE THEY QUICKLY SWAPPED OUT THE WRAP. THE PATIENT INVOLVED IN THE INCIDENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118596 ↗
• MalfunctionDec 1, 2022Insufficient Cooling; Insufficient Cooling

  COOLING BLANKET FAILED DURING THERAPEUTIC COOLING OF A NEONATE. NO CHANGE IN PATIENT'S TEMPERATURE. ABLE TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15898801 ↗
• MalfunctionJan 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT MEDICAL TECHNOLOGIES RECEIVED A REPORT FROM THE USER FACILITY THAT AN INFANT CUREWRAP LEAKED WHILE IN USE CAUSING THE BABY TO BECOME WET. THE CUREWRAP WAS REPLACED AND THERAPY CONTINUED WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11136122 ↗
• MalfunctionMay 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT AN INFANT CUREWRAP WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10048414 ↗

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, Classified
  CritiCool, thermoregulation device