IsoTour 2872 (REF 2872-000-011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327424607), received between Jun 2, 2021 and Jun 9, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A DEEP TISSUE INJURY WHILE USING THE ISOTOUR SURFACE. FURTHER INVESTIGATION IDENTIFIED THAT THE ISOTOUR SURFACE HAD NOT MALFUNCTIONED AND HAD NOT CONTRIBUTED TO THE ALLEGED INJURY IN ANY WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11970293 ↗
• MalfunctionJun 8, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. THE USER FACILITY STATED THAT ALL TURNING AND INJURY PREVENTION PROTOCOLS WERE FOLLOWED; HOWEVER, DUE TO THE PATIENT'S SKIN CONDITION AND BRADEN SCORES THEY WERE AT RISK FOR DEVELOPING A PRESSURE INJURY BEFORE BEING PLACED ON THE ISOTOUR SURFACE. THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CONTRIBUTE TO PRESSURE INJURIES, SUCH AS NUTRITION, SKIN CONDITION, MOISTURE AND PRESSURE INJURY TREATMENT PROTOCOL. GIVEN THAT ALL FACTORS THAT ARE WITHIN STRYKER¿S CONTROL WERE EVALUATED AND FOUND TO BE OPERATING AS INTENDED, IT WAS DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE ISOTOUR SURFACE THAT WOULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE ALLEGED PRESSURE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11962223 ↗
• MalfunctionJun 8, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. THE USER FACILITY STATED THAT ALL TURNING AND INJURY PREVENTION PROTOCOLS WERE FOLLOWED; HOWEVER, DUE TO THE PATIENT'S SKIN CONDITION AND BRADEN SCORES THEY WERE AT RISK FOR DEVELOPING A PRESSURE INJURY BEFORE BEING PLACED ON THE ISOTOUR SURFACE. THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CONTRIBUTE TO PRESSURE INJURIES, SUCH AS NUTRITION, SKIN CONDITION, MOISTURE AND PRESSURE INJURY TREATMENT PROTOCOL. GIVEN THAT ALL FACTORS THAT ARE WITHIN STRYKER¿S CONTROL WERE EVALUATED AND FOUND TO BE OPERATING AS INTENDED, IT WAS DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE ISOTOUR SURFACE THAT WOULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE ALLEGED PRESSURE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11961934 ↗
• MalfunctionJun 8, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. THE USER FACILITY STATED THAT ALL TURNING AND INJURY PREVENTION PROTOCOLS WERE FOLLOWED; HOWEVER, DUE TO THE PATIENT'S SKIN CONDITION AND BRADEN SCORES THEY WERE AT RISK FOR DEVELOPING A PRESSURE INJURY BEFORE BEING PLACED ON THE ISOTOUR SURFACE. THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CONTRIBUTE TO PRESSURE INJURIES, SUCH AS NUTRITION, SKIN CONDITION, MOISTURE AND PRESSURE INJURY TREATMENT PROTOCOL. GIVEN THAT ALL FACTORS THAT ARE WITHIN STRYKER¿S CONTROL WERE EVALUATED AND FOUND TO BE OPERATING AS INTENDED, IT WAS DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE ISOTOUR SURFACE THAT WOULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE ALLEGED PRESSURE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11961932 ↗
• MalfunctionJun 8, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. THE USER FACILITY STATED THAT ALL TURNING AND INJURY PREVENTION PROTOCOLS WERE FOLLOWED; HOWEVER, DUE TO THE PATIENT'S SKIN CONDITION AND BRADEN SCORES THEY WERE AT RISK FOR DEVELOPING A PRESSURE INJURY BEFORE BEING PLACED ON THE ISOTOUR SURFACE. THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CONTRIBUTE TO PRESSURE INJURIES, SUCH AS NUTRITION, SKIN CONDITION, MOISTURE AND PRESSURE INJURY TREATMENT PROTOCOL. GIVEN THAT ALL FACTORS THAT ARE WITHIN STRYKER¿S CONTROL WERE EVALUATED AND FOUND TO BE OPERATING AS INTENDED, IT WAS DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE ISOTOUR SURFACE THAT WOULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE ALLEGED PRESSURE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11961913 ↗
• MalfunctionJun 8, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. THE USER FACILITY STATED THAT ALL TURNING AND INJURY PREVENTION PROTOCOLS WERE FOLLOWED; HOWEVER, DUE TO THE PATIENT'S SKIN CONDITION AND BRADEN SCORES THEY WERE AT RISK FOR DEVELOPING A PRESSURE INJURY BEFORE BEING PLACED ON THE ISOTOUR SURFACE. THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CONTRIBUTE TO PRESSURE INJURIES, SUCH AS NUTRITION, SKIN CONDITION, MOISTURE AND PRESSURE INJURY TREATMENT PROTOCOL. GIVEN THAT ALL FACTORS THAT ARE WITHIN STRYKER¿S CONTROL WERE EVALUATED AND FOUND TO BE OPERATING AS INTENDED, IT WAS DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE ISOTOUR SURFACE THAT WOULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE ALLEGED PRESSURE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11961876 ↗
• MalfunctionJun 8, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. THE USER FACILITY STATED THAT ALL TURNING AND INJURY PREVENTION PROTOCOLS WERE FOLLOWED; HOWEVER, DUE TO COVID-19 AS WELL AS THE PATIENT'S BRADEN SCORES THEY WERE AT RISK FOR DEVELOPING A PRESSURE INJURY BEFORE BEING PLACED ON THE ISOTOUR SURFACE. THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CONTRIBUTE TO PRESSURE INJURIES, SUCH AS NUTRITION, SKIN CONDITION, MOISTURE AND PRESSURE INJURY TREATMENT PROTOCOL. GIVEN THAT ALL FACTORS THAT ARE WITHIN STRYKER¿S CONTROL WERE EVALUATED AND FOUND TO BE OPERATING AS INTENDED, IT WAS DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE ISOTOUR SURFACE THAT WOULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE ALLEGED PRESSURE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11958587 ↗
• MalfunctionJun 8, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. THE USER FACILITY STATED THAT ALL TURNING AND INJURY PREVENTION PROTOCOLS WERE FOLLOWED; HOWEVER, DUE TO COVID-19 AS WELL AS THE PATIENT'S BRADEN SCORES THEY WERE AT RISK FOR DEVELOPING A PRESSURE INJURY BEFORE BEING PLACED ON THE ISOTOUR SURFACE. THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CONTRIBUTE TO PRESSURE INJURIES, SUCH AS NUTRITION, SKIN CONDITION, MOISTURE AND PRESSURE INJURY TREATMENT PROTOCOL. GIVEN THAT ALL FACTORS THAT ARE WITHIN STRYKER¿S CONTROL WERE EVALUATED AND FOUND TO BE OPERATING AS INTENDED, IT WAS DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE ISOTOUR SURFACE THAT WOULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE ALLEGED PRESSURE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11958583 ↗
• MalfunctionJun 2, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. ADDITIONAL INFORMATION REGARDING THE PRESSURE INJURY HAS BEEN REQUESTED FROM THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11922981 ↗