CureWrap™ Infant, 2.5-4Kg 500-03518Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290012127182), received between May 12, 2020 and Mar 5, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Leak/Splash

  IT WAS REPORTED THAT A BABY UNDERGOING THERAPEUTIC HYPOTHERMIA EXPERIENCED LEAKAGE FROM THE COOLING MATTRESS/WRAP SYSTEM DURING TREATMENT. IT WAS NOTED THAT LEAKAGE HAD OCCURRED MULTIPLE TIMES DURING THE COOLING PERIOD. IN TOTAL, THREE COOLING WRAPS WERE USED PRIOR TO THE FINAL INCIDENT DURING THE REWARMING PHASE. THE INFANT WAS FOUND WET ON FOUR OCCASIONS DURING TREATMENT. DURING THE REWARMING PHASE, WITH APPROXIMATELY 45 MINUTES REMAINING, LEAKAGE WAS AGAIN IDENTIFIED, WHICH SLOWED THE REWARMING PROCESS. THE MEDICAL TEAM MADE THE DECISION TO REMOVE THE COOLING MATTRESS, DRY THE INFANT, AND ALLOW REWARMING TO CONTINUE WITHOUT THE DEVICE FOR THE REMAINING DURATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524171 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak; Product Quality Problem

  RECEIVED BABY ON THERAPEUTIC COOLING WITH CUREWRAP COOLING JACKET ON. THE STAFF OBSERVED THE JACKET WAS WET ON THE HEAD AREA AND SOAKING THROUGH THE SHEETS. ALL OTHER AREAS OF THE JACKET WAS DRY AND THE JACKET WAS NOT FILLED WITH WATER. AFTER THE STAFF NOTICED THIS, THEY REPLACED THE COOLING JACKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192377 ↗
• MalfunctionAug 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT, " COOLING BLANKETS WERE CHANGED THREE TIMES DUE TO DIFFUSE LEAKING ON THE SURFACE OF THE BLANKETS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22705914 ↗
• MalfunctionMay 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER REPORTED THAT, WHILE ASSESSING THE BABY, THE COOLING BLANKET WAS NOTED TO BE LEAKING AND A PUDDLE WAS FORMED. INFANT IMMEDIATELY CHANGED TO NEW COOLING BLANKET, DRIED, AND STABILIZED. LEAKING BLANKET WAS SET ASIDE FOR AN INVESTIGATION. THERE IS NO PATIENT HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952302 ↗
• MalfunctionJun 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT MEDICAL TECHNOLOGIES RECEIVED A REPORT FROM THE USER FACILITY THAT AN INFANT CUREWRAP LEAK STARTED AS A SLOW DRIP AND BECAME A CONSISTENT SPRAY WHEN CLAMPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028775 ↗
• MalfunctionMay 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT THE INFANT CUREWRAP WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823271 ↗
• MalfunctionNov 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT'S DISTRIBUTOR RELAYED A REPORT FROM THE USER FACILITY THAT THE CURE WRAP LEAKED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10805965 ↗
• MalfunctionMay 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT AN INFANT CUREWRAP WAS LEAKING AT THE PLASTIC CONNECTION SIDE OF THE BLANKET.

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

  MAUDE report 10047512 ↗

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