BREG POLAR CARE CUBERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00672736017647), received between Mar 7, 2018 and Feb 3, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BREG RECEIVED MEDWATCH REPORT ALLEGING THE FOLLOWING, "POLAR CUBE WAS DISCONNECTED IN THE PATIENT'S ROOM AND THE COOLING PAD WAS WORN BY THE PATIENT UNDERNEATH THE BULKY DRESSING (STATUS POST TOTAL KNEE ARTHROPLASTY). THE ENDS OF THE TUBES ARE SUPPOSED TO SEAL WHEN DISCONNECTED. WHILE PATIENT WAS PARTICIPATING IN PHYSICAL THERAPY, A SMALL AMOUNT OF WATER HAD DRIPPED UNNOTICED ON THE STEPS. PATIENT SLIPPED ON THE WATER WHILE DESCENDING THE STAIRS CAUSING THE LEG TO FLEX FULLY AND INTERNALLY ROTATE. 5-6 DRIPS OF WATER WERE NOTED ON THE TOP STEPS WHILE PATIENT WAS SITTING AND RESTING ON THE STEPS. PATIENT REQUIRED SURGERY LATER TO REPAIR A TORN QUAD TENDON".

  Patient problems: Muscle/Tendon Damage

  MAUDE report 16294436 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem

  THROUGH LEGAL NOTICE BREG, INC. RECEIVED A REPORT OF AN ALLEGED INCIDENT INVOLVING A POLAR CARE CUBE. THE COURT DOCUMENT ALLEGES THAT IN 2018, THE PLAINTIFF SUFFERED "FOCAL NECROSIS, MUSCLE WASTING, AND COMPLEX REGIONAL PAIN SYNDROME, WHICH IS A FORM OF HYPER-SENSITIVE NERVE DAMAGE THAT IS IRREVERSIBLE, DISABLING, AND EXTREMELY PAINFUL".

  Patient problems: Disability; Hypersensitivity/Allergic reaction; Necrosis; Nerve Damage; No Code Available; Pain

  MAUDE report 9727684 ↗
• MalfunctionApr 10, 2019Fluid/Blood Leak

  OUR HOSPITAL HAS NOTICED A TREND IN ICE/WATER CONTAINERS LEAKING DURING POST-SURGICAL ORTHOPEDIC SURGERY. NO HARM TO ANY PATIENTS BUT OVER THE PAST MONTH OR SO WE'VE SEE APPROXIMATELY 9 ICE COOLERS AND/ OR THEIR CONNECTED PADS LEAKING. WE HAVE BEEN SENDING THE ICE BOXES AND PADS BACK TO THE MANUFACTURER FOR REPLACEMENTS AND WE CAME TO UNDERSTAND THE CONSISTENT NEED TO REPLACE SO MANY WE FELT IT TIME TO LOOK AT THE ISSUE. MOST ICE COOLER BOXES AND THE RELATED CONNECTING PADS ARE NOT FULLY IDENTIFIED AS FAR AS LOT NUMBERS; HOWEVER, WE FELT WE NEEDED TO MOVE FORWARD WITH AT LEAST 1 LOT NUMBER OF A KNOWN-DEVICE. AGAIN, NO PATIENT HARM BUT JUST ASPECT OF THE DEVICES CONSISTENTLY LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8499835 ↗
• InjuryMar 7, 2018Improper or Incorrect Procedure or Method

  REPORTED INCIDENT OF A BURN ON FOREARM OF PATIENT RESULTING FROM DIRECT CONTACT FROM POLAR CARE WRAP. THE FOLLOWING WAS COMMUNICATED BY EMAIL: "... THE STAFF KNOWS THAT THERE NEEDS TO BE A BARRIER BETWEEN THE WRAP AND THE SKIN, BUT APPARENTLY SOMEONE EITHER DID NOT MAKE SURE THAT THERE WAS A BARRIER, OR DID NOT EDUCATE THE PATIENT ABOUT THIS." UNKNOWN WHETHER PATIENT REQUIRED MEDICAL OR SURGICAL INTERVENTION. NO IMPAIRMENT OR PERMANENT DAMAGE SUSTAINED.

  Patient problems: Burn(s)

  MAUDE report 7321360 ↗