Thermogard™ Vest, L/XLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00849111076135), received between Aug 13, 2024 and Mar 25, 2026 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT #1: DURING THE USE OF STX SURFACE PADS WITH BLANKETROL FOR POST-CARDIAC ARREST THERAPY TO COOL A PATIENT TO 36°C, THE NURSE OBSERVED SKIN BREAKDOWN ON THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT DEVELOPED BLISTERING TO THE POINT OF BLEEDING, WITH INDENTATIONS MIRRORING A HONEYCOMB SHAPE. ACCORDING TO THE CUSTOMER, THE PADS WERE NOT APPLIED TOO TIGHTLY, AND THE NURSING STAFF WAS DOING SKIN CHECKS EVERY 2 HOURS. THE CUSTOMER ALSO STATED THAT THE PRODUCT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH APPROPRIATE CORE TEMPERATURE MONITORING AND PROPER EQUIPMENT FUNCTION THROUGHOUT THERAPY.

  Patient problems: Skin Tears

  MAUDE report 24695390 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT #3: DURING THE USE OF STX SURFACE PADS WITH BLANKETROL FOR POST-CARDIAC ARREST THERAPY TO COOL A PATIENT TO 36°C, THE NURSE OBSERVED SKIN BREAKDOWN ON THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT DEVELOPED BRUISE-LIKE CHANGES ON THE BACK WITHOUT NOTABLE INVOLVEMENT OR SCARRING. ACCORDING TO THE CUSTOMER, THE PADS WERE NOT APPLIED TOO TIGHTLY, AND THE NURSING STAFF WAS DOING SKIN CHECKS EVERY 2 HOURS. THE CUSTOMER ALSO STATED THAT THE PRODUCT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH APPROPRIATE CORE TEMPERATURE MONITORING AND PROPER EQUIPMENT FUNCTION THROUGHOUT THERAPY.

  Patient problems: Skin Tears

  MAUDE report 24695389 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT # 3: DURING THE USE OF STX SURFACE PADS WITH BLANKET ROL FOR POST-CARDIAC ARREST THERAPY TO COOL A PATIENT TO 36°C, THE NURSE OBSERVED SKIN BREAKDOWN ON THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT DEVELOPED BRUISE-LIKE CHANGES ON THE BACK WITHOUT NOTABLE INVOLVEMENT OR SCARRING. ACCORDING TO THE CUSTOMER, THE PADS WERE NOT APPLIED TOO TIGHTLY, AND THE NURSING STAFF WAS DOING SKIN CHECKS EVERY 2 HOURS. THE CUSTOMER ALSO STATED THAT THE PRODUCT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH APPROPRIATE CORE TEMPERATURE MONITORING AND PROPER EQUIPMENT FUNCTION THROUGHOUT THERAPY.

  Patient problems: Skin Tears

  MAUDE report 24695388 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT #1: DURING THE USE OF STX SURFACE PADS WITH BLANKETROL FOR POST-CARDIAC ARREST THERAPY TO COOL A PATIENT TO 36°C, THE NURSE OBSERVED SKIN BREAKDOWN ON THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT DEVELOPED BLISTERING TO THE POINT OF BLEEDING, WITH INDENTATIONS MIRRORING A HONEYCOMB SHAPE. ACCORDING TO THE CUSTOMER, THE PADS WERE NOT APPLIED TOO TIGHTLY, AND THE NURSING STAFF WAS DOING SKIN CHECKS EVERY 2 HOURS. THE CUSTOMER ALSO STATED THAT THE PRODUCT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH APPROPRIATE CORE TEMPERATURE MONITORING AND PROPER EQUIPMENT FUNCTION THROUGHOUT THERAPY.

  Patient problems: Skin Tears

  MAUDE report 24695387 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT #2: DURING THE USE OF STX SURFACE PADS WITH BLANKETROL FOR POST-CARDIAC ARREST THERAPY TO COOL A PATIENT TO 36°C, THE NURSE OBSERVED SKIN BREAKDOWN ON THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT DEVELOPED BRUISE-LIKE CHANGES ON THE BACK WITHOUT NOTABLE INVOLVEMENT OR SCARRING. ACCORDING TO THE CUSTOMER, THE PADS WERE NOT APPLIED TOO TIGHTLY, AND THE NURSING STAFF WAS DOING SKIN CHECKS EVERY 2 HOURS. THE CUSTOMER ALSO STATED THAT THE PRODUCT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH APPROPRIATE CORE TEMPERATURE MONITORING AND PROPER EQUIPMENT FUNCTION THROUGHOUT THERAPY.

  Patient problems: Skin Tears

  MAUDE report 24694825 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT #2: DURING THE USE OF STX SURFACE PADS WITH BLANKETROL FOR POST-CARDIAC ARREST THERAPY TO COOL A PATIENT TO 36°C, THE NURSE OBSERVED SKIN BREAKDOWN ON THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT DEVELOPED BRUISE-LIKE CHANGES ON THE BACK WITHOUT NOTABLE INVOLVEMENT OR SCARRING. ACCORDING TO THE CUSTOMER, THE PADS WERE NOT APPLIED TOO TIGHTLY, AND THE NURSING STAFF WAS DOING SKIN CHECKS EVERY 2 HOURS. THE CUSTOMER ALSO STATED THAT THE PRODUCT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH APPROPRIATE CORE TEMPERATURE MONITORING AND PROPER EQUIPMENT FUNCTION THROUGHOUT THERAPY.

  Patient problems: Skin Tears

  MAUDE report 24694813 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT EXPERIENCED A SKIN INJURY WHILE UNDERGOING TREATMENT USING THE BLANKETROL III CONSOLE WITH THE STX SURFACE COOLING PAD (LOT# UNKNOWN) FOR TEMPERATURE MAINTENANCE. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19969843 ↗