ThermoSuit System TSP-50 Pump/ControllerRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851936007003), received between Feb 16, 2026 and Feb 16, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K061023); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Electrical /Electronic Property Problem

  CLINICIANS AT (B)(6) MEDICAL CENTER USED THE LIFE RECOVERY SYSTEMS THERMOSUIT SYSTEM TO COOL A PATIENT FOLLOWING CARDIAC ARREST IN ACCORDANCE WITH THEIR STANDARD CLINICAL PRACTICE. THE TSP-50 PUMP WAS ACTIVATED WITH THE THERMOSUIT BODY ENCLOSURE (TBE) APPLIED TO THE PATIENT. THE TOP SHEET WAS ATTACHED TO THE TBE OVER THE FRONT OF THE PATIENT, LEAVING THE FACE EXPOSED. THE TSP-50 RESERVOIR WAS FILLED WITH APPROXIMATELY 40 LITERS OF ICE WATER. A 400-SERIES THERMISTOR TEMPERATURE PROBE FROM THE DISPOSABLES KIT WAS INSERTED INTO THE PATIENT'S ESOPHAGUS AND CONNECTED TO THE TSP-50 FOR CONTINUOUS TEMPERATURE MONITORING. SHORTLY AFTER ACTIVATION OF THE WATER PUMPS, THE TSP-50 EXPERIENCED INTERMITTENT POWER LOSS AND STOPPED CIRCULATING WATER THROUGH THE ENCLOSURE, REPRESENTING A DEVICE MALFUNCTION AND INTERRUPTION OF COOLING THERAPY. THE ATTENDING PHYSICIAN CONTACTED LRS TECHNICAL SUPPORT. DURING THE CALL, TECHNICAL SUPPORT DISCUSSED ALTERNATIVE TEMPERATURE MONITORING CONFIGURATION USING THE 400-SERIES PROBE AND A NEARBY COMPATIBLE TEMPERATURE MONITOR. CLINICAL STAFF REMOVED THE TOP SHEET FROM THE ENCLOSURE AND MANUALLY TRANSFERRED WATER FROM THE RESERVOIR ONTO THE FRONT OF THE PATIENT USI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345778 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061023. One submission often covers many models, so check the product and lot details in each record.

• Z-0456-2012 · Oct 21, 2011 · Terminated
  ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800 FAx.: (973) 283-2910 Temperature reduction in patients wh