Guardian GS-2.5-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00860001236453), received between Mar 15, 2024 and Jul 21, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Malposition of Device” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Nov 1, 2023Class IIOpen, Classified

   A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

   Z-1967-2025 · Root cause: Software design · Recall details · FDA record ↗

2. Aug 10, 2023Class IIOpen, Classified

   A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

   Z-1968-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Use of Device Problem; Use of Device Problem

  PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) MAR. ON (B)(6) 2025 A STAGE 3 PRESSURE INJURY WAS OBSERVED ON THE BUTTOCKS BY THE FACILITY. THERE WAS NO INDICATION OF INJURY PROGRESSION OR WHAT, IF ANY, ADDITIONAL TREATMENT WAS REQUIRED FOR THE PRESSURE INJURY. REVIEW OF THE GUARDIAN SYSTEM CONTROLLER DATA NOTED THERE WERE USER FACING EVENTS RELATED TO POTENTIAL LEAKAGE OF AIR WITHIN THE SYSTEM IN THE DAYS LEADING UP TO THE INJURY DISCOVERY. THESE ALERTS PROMPT THE USER TO ADDRESS THE ISSUE, INCLUDING CHANGING OUT OF THE SURFACE IF NECESSARY. DATA FROM THE SYSTEM INDICATED THAT SOME OF THESE LEAK ALERT EVENTS WENT UNADDRESSED FOR EXCESS PERIODS OF TIME (> 3.5 HOURS AND > 10.5 HOURS). IN ADDITION, SOME LEAK ALERT EVENTS WERE CLEARED BY THE USER WITHOUT CHANGING OF THE SURFACE. IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE, AN UPDATE TO THIS REPORT WILL BE FILED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22554460 ↗
• InjuryMar 3, 2025Failure to Run on Battery; Failure to Run on Battery

  PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025 A DTI WAS OBSERVED ON THE ISCHIUM BY THE FACILITY. THERE WAS NO INDICATION OF INJURY PROGRESSION OR WHAT, IF ANY, ADDITIONAL TREATMENT WAS REQUIRED FOR THE PRESSURE INJURY. REVIEW OF THE GUARDIAN SYSTEM CONTROLLER DATA SHOWED INCIDENCES OF TERMINAL BATTERY SHUTDOWNS OF THE CONTROLLER, RESULTING IN TIMES WHERE THE GUARDIAN SYSTEM WAS NOT RUNNING. THE TERMINAL BATTERY EVENTS OCCURRED IF THE CONTROLLER WAS UNPLUGGED FROM AC POWER, AND WHEN THIS OCCURRED THE TERMINAL BATTERY SOFTWARE WARNINGS/ALERTS, PROMPTING ACTION TO THE USER, WERE OPERATING PROPERLY. WHEN CONNECTED TO AC POWER, THE CONTROLLER OPERATED CONTINUALLY WITHOUT ISSUE. THE ASSOCIATED CONTROLLER WAS EVENTUALLY RETURNED TO TURNCARE FOR SERVICE AT WHICH TIME THE POWER SUPPLY WAS REPLACED. IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE, AN UPDATE TO THIS REPORT WILL BE FILED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21503732 ↗
• InjuryJan 3, 2025Use of Device Problem; Use of Device Problem

  PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024, A STAGE 3 PRESSURE INJURY WAS OBSERVED ON THE SACRUM BY THE FACILITY. THERE WAS NO INDICATION OF INJURY PROGRESSION OR WHAT, IF ANY, ADDITIONAL TREATMENT WAS REQUIRED FOR THE PRESSURE INJURY. REVIEW OF THE GUARDIAN SYSTEM CONTROLLER DATA NOTED "LEAK ALERT" EVENTS PRIOR TO THE INJURY EVENT OCCURRENCE, RESULTING IN THE CONTROLLER PROMPTING THE HEALTHCARE PROFESSIONAL TO TAKE ACTION TO REPLACE THE SURFACE. THE "LEAK ALERT" EVENTS WERE MANUALLY CLEARED BY THE USER WITHOUT REPLACEMENT OF THE SURFACE DURING THE TIME PERIOD LEADING UP TO THE PRESSURE INJURY DISCOVERY. IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE AN UPDATE TO THIS REPORT WILL BE FILED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21070385 ↗
• InjuryAug 30, 2024Inflation Problem; Inflation Problem

  PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024 A STAGE 3 PRESSURE INJURY WAS OBSERVED ON THE BUTTOCKS BY THE FACILITY. THERE WAS NO INDICATION OF INJURY PROGRESSION OR WHAT, IF ANY, ADDITIONAL TREATMENT WAS REQUIRED FOR THE PRESSURE INJURY. REVIEW OF THE GUARDIAN SYSTEM CONTROLLER DATA NOTED "LEAK ALERT" EVENTS PRIOR TO THE INJURY EVENT OCCURRENCE, RESULTING IN THE CONTROLLER PROMPTING THE HEALTHCARE PROFESSIONAL TO TAKE ACTION. REPLACEMENT OF THE BED SURFACE WAS DELAYED BY THE HEALTHCARE PROFESSIONAL BASED ON THEIR JUDGMENT OF PATIENT CONDITIONS AND TREATMENT OPTIONS. IT WAS REPORTED THE PATIENT HAD AN ACUTE RESPIRATORY ILLNESS, EXPERIENCED PAIN AND OXYGEN DESATURATION WITH MOVEMENT, AND WAS REFUSING STANDARD PATIENT TURN PRACTICES. THE ASSOCIATED CONTROLLER WAS EVENTUALLY RETURNED TO TURNCARE FOR SERVICE AT WHICH TIME A MANIFOLD VALVE WAS REPLACED. IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE, AN UPDATE TO THIS REPORT WILL BE FILED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20113693 ↗
• InjuryJun 11, 2024Use of Device Problem; Use of Device Problem

  PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024 AN EVOLVING DTI WOUND WAS OBSERVED ON THE COCCYX THAT OPENED TO A STAGE 3 PRESSURE INJURY. THE WOUND WAS CLASSIFIED AS A PSI 03 INJURY BY THE CUSTOMER. THE CUSTOMER REPORTED USE OF TOPICAL APPLICATION AND DRESSING TO TREAT THE WOUND. IT WAS NOTED THE INJURY DID NOT PROGRESS FROM ITS INITIAL DISCOVERY. REPORTED DETAILS FROM THE CUSTOMER: "DISCHARGED 58 YR OLD 31 DAYS ADMITTED WITH AN ICH AND RT CRANIOTOMY. NEEDING A TACH AND PEG TUBE PLACEMENT. NEEDING SEVERAL STAYS IN ICU (B)(6) AND BACK ON (B)(6). PATIENT WITH MORBID OBESITY. 279 LBS FLACCID ON HIS LF SIDE. WOUND CONSULT PLACED (B)(6) BY NURSE AND SEEN (B)(6). WOUND ON COCCYX WITH EVOLVING DTI THAT OPENED INTO A STAGE 3. NUTRITION CONSULTED (B)(6). ALL INTERVENTIONS IN PLACE. ON TURNCARE, SPRY PILLOWS, WITH A FOLEY UNTIL DAY OF DISCHARGE, AND OUT OF BED TO CHAIR. TURNED AND REPOSITIONED AS OFTEN AS SAFELY POSSIBLE DUE TO DESATTING WHEN REPOSITIONING." REVIEW OF THE GUARDIAN SYSTEM DATA NOTED THE CONTROLLER USED FOR THIS PATIENT HAD A TERMINAL BATTERY SHUTDOWN OF GREATER THAN 20 HOURS, STARTING THE DAY PRIOR TO INJURY IDENTIFICATION AND PATIENT WAS RE-ENROLLED ON T

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19510673 ↗
• InjuryMay 22, 2024Obstruction of Flow; Obstruction of Flow

  PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON 05-APR-2024 A STAGE 3 PRESSURE INJURY WAS OBSERVED ON THE NATAL CLEFT. IT WAS NOTED THE INJURY PROGRESSED FROM A MASD TO A STAGE 3 PRESSURE INJURY. NO FURTHER DETAILS WERE REPORTED REGARDING THE REASON FOR PATIENT HOSPITAL ADMISSION, OR WITH REGARDS TO OUTCOMES FROM THE STAGE 3 INJURY OBSERVED. REVIEW OF THE GUARDIAN SYSTEM DATA NOTED MULTIPLE PINCH ALERT "AIRFLOW BLOCKED" EVENTS, ACCOUNTING FOR A TOTAL OF 14.68 HOURS OF GAPS IN THERAPY (27% OF TOTAL GAPS IN THERAPY) FROM ADMISSION TO INJURY DISCOVERY. IT WAS ALSO NOTED THE PINCH ALERTS WERE CLEARED MULTIPLE TIMES BY THE USER WITHOUT RESOLUTION. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19373609 ↗
• InjuryApr 25, 2024Malposition of Device; Malposition of Device

  PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024 A DTI WAS OBSERVED. IT WAS NOTED THE PATIENT WAS CONTRACTED WITH MINIMAL MOVEMENT BY SELF IN AND OUT OF A CHAIR WITH SLING. NO FURTHER DETAILS WERE REPORTED REGARDING THE REASON FOR PATIENT HOSPITAL ADMISSION, OR WITH REGARDS TO OUTCOMES FROM THE DTI OBSERVED. THE HOSPITAL CONTACT INDICATED THEY DID NOT BELIEVE THE GUARDIAN SYSTEM CAUSED OR CONTRIBUTED TO THE INJURY EVENT. REVIEW OF THE GUARDIAN SYSTEM DATA NOTED EVENTS OF NO INTERACTION WITH THE GUARDIAN SYSTEM FOR AT LEAST 48 HOURS, WHICH MEANS THERAPY WASN'T PAUSED FOR PATIENT CARE/TURNING & POSITIONING. NUMEROUS LOGGED EVENTS OF "NO PATIENT DETECTED" AND "SUSPECTED PATIENT MISPOSITION" WERE ALSO NOTED. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19181350 ↗
• InjuryApr 16, 2024Malposition of Device; Malposition of Device

  PATIENT WAS ADMITTED TO THE HOSPITAL WITH PANCYTOPENIA ON (B)(6) 2024. PATIENT WAS INITIALLY DIAGNOSED WITH A DTI ON 09-MAR-2024, WHICH EVOLVED TO A STAGE 3 INJURY ASSESSED ON 15-MAR-2024. THE REPORTED ESCALATION TO STAGE 3 OCCURRED 4 DAYS AFTER THE PATIENT WAS NO LONGER ENROLLED ON THE GUARDIAN SYSTEM. INITIAL REPORT FROM THE HOSPITAL CONTACT INDICATED "SKIN INDENTATIONS FROM THE TURNCARE MAT WERE PALPABLE UPON ROLLING THE PATIENT". THE INITIAL BELIEF FROM THE HOSPITAL WAS THE INDENTATIONS WERE FROM THE TUBING OF THE ENHANCER. ADDITIONAL FOLLOW UP FROM THE HOSPITAL WOUND CARE RN COULD NOT BE CERTAIN WHETHER THE WOUND WAS CAUSED BY THE TURNCARE DEVICE. BASED ON A REVIEW OF INJURY PHOTOS, TURNCARE MEDICAL PERSONNEL DO NOT BELIEVE THE WOUND WAS CAUSED BY THE ENHANCER TUBING SINCE THE NATURE OF THE WOUND IS NOT CONSISTENT WITH WHAT WOULD BE EXPECTED FROM ONE CAUSED BY IMPRESSION FROM THE ENHANCER TUBING. WHEN USED ACCORDING TO TURNCARE STANDARD EDUCATION AND BEST PRACTICE, THE TUBING DOES NOT COME IN CONTACT WITH THE PATIENT'S SKIN. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19115706 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED ON (B)(6) 2022. A DTPI WAS OBSERVED IN THE SACRUM/NATAL CLEFT AREA ON (B)(6) 2022. NO FURTHER INFORMATION ON TREATMENT OF THE DTPI WAS PROVIDED. EVALUATION OF GUARDIAN DATA NOTED SEVERAL GAPS IN THERAPY, INCLUDING A TOTAL OF 19 HOURS 5 MINS DUE TO ENHANCER DISCONNECT. THIS INCLUDED 4 EPISODES, TOTALING 8HRS 22 MINS BETWEEN (B)(6) 2022. IT WAS ALSO NOTED THE INCORRECT PATIENT WEIGHT RANGE WAS SELECTED (SELECTED RANGE WAS 126-136KG). THERE WERE NO INDICATIONS OF DEVICE MALFUNCTION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19018710 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED ON (B)(6) 2022. PATIENT WAS DISCHARGED OFF THE GUARDIAN SYSTEM ON (B)(6) 2022 AND NOT RE-ENROLLED FOR THE DURATION OF THEIR STAY. ON (B)(6) 2022, A STAGE 2 PRESSURE INJURY WAS OBSERVED TO THE SACRAL REGION, WHICH PROGRESSED TO A STAGE 3 INJURY AS OF (B)(6) 2022. NO FURTHER INFORMATION ON TREATMENT OF THE PRESSURE INJURY WAS PROVIDED. IT IS NOTED THE PRESSURE INJURY WAS OBSERVED TWO DAYS AFTER THE PATIENT WAS DISCHARGED OFF THE GUARDIAN SYSTEM WITHOUT RE-ENROLLMENT. EVALUATION OF GUARDIAN DATA NOTED SEVERAL GAPS IN THERAPY, INCLUDING SEVERAL GAPS DUE TO PATIENT DISCHARGES FROM THE SYSTEM (GREATER THAN 92 TOTAL HOURS). THERE WERE NO INDICATIONS OF DEVICE MALFUNCTION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19018709 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED ON (B)(6) 2022. TWO PRESSURE INJURIES WERE OBSERVED ON THE PATIENT. A SACRUM DTI EVOLVED TO A STAGE 3 INJURY ON (B)(6) 2022. A SACRUM UNSTAGEABLE WITH DTPI DEBRIDED ON (B)(6) 2022 TO A STAGE 4. EVALUATION OF GUARDIAN DATA NOTED NO INDICATIONS OF DEVICE MALFUNCTION OR SIGNIFICANT GAPS IN THERAPY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19018693 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED ON (B)(6) 2023. THE PATIENT WEIGHT RANGE SELECTION FOR THE GUARDIAN DEVICE WAS 81-91KG. ON (B)(6) 2023, A DTI WAS IDENTIFIED ON THE PATIENT. THERE WAS NO FURTHER INDICATION OF INJURY PROGRESSION OR WHAT TREATMENT, IF ANY, WAS REQUIRED TO TREAT THE DTI. EVALUATION OF GUARDIAN DATA LEADING UP TO THE DTI DISCOVERY WAS PERFORMED. A TOTAL DELAY OF 19.5 HOURS IN TIME TO INITIATE THERAPY WAS NOTED, AND POTENTIALLY 12.3 HOURS OF GAPS IN THERAPY WAS ALSO NOTED. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS INCIDENT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19018692 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED ON (B)(6) 2023. PATIENT'S STAGE 2 ON NATAL CLEFT PROGRESSED TO UNSTAGEABLE ON (B)(6) 2023. EVALUATION OF GUARDIAN DATA WAS COMPILED FOR DATES PRIOR TO HAPI DISCOVERY. A TOTAL GAP IN THERAPY OF 143.5 HOURS WAS REVIEWED, WHICH INCLUDED: 12.5 HOURS OF DISCONNECTED ENHANCER, 92 HOUR DELAY IN THERAPY WHEN TRANSFERRING BETWEEN UNITS, 34.5 HOURS OF NO PATIENT DETECTED/MISPOSITIONED ENHANCER, AND 4.5 HOURS OF THE PAUSE FEATURE RUNNING FOR THE FULL 30 MINUTES. THERE WERE ALSO 14.5 TOTAL DAYS UTILIZING THE DEVICE WITH AN INCORRECT WEIGHT SELECTION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19018688 ↗
• InjuryMar 27, 2024Malposition of Device; Malposition of Device

  PATIENT WAS INITIALLY DIAGNOSED WITH AN UNSTAGEABLE PRESSURE INJURY ON (B)(6) 2024. THE LAST ASSESSMENT ON (B)(6) 2024 CLASSIFIED THE INJURY AS A STAGE 3. THE LOCATION OF THE INJURY IS ON THE NATAL CLEFT. THE REPORTING FACILITY INDICATED THEY USED A TOPICAL APPLICATION AND DRESSING TO TREAT THE PRESSURE INJURY. THE REPORTING FACILITY INDICATED THEY DO NOT BELIEVE THE GUARDIAN DEVICE CAUSED OR CONTRIBUTED TO THE INJURY OBSERVED ON THE PATIENT. INVESTIGATION OF THE AVAILABLE INFORMATION FROM THE GUARDIAN SYSTEM NOTED 8 INCIDENCES WHERE THE USING FACILITY DID NOT UTILIZE THE PAUSE FEATURE OF THE DEVICE FOR 12 CONSECUTIVE HOURS, WHICH CAN LEAD TO ENHANCER MIGRATION. ON (B)(6) 2024 THERAPY WAS PAUSED AND THEN RESUMED WITH THE ENHANCER POTENTIALLY MISPOSITIONED. THIS IS BASED ON A REVIEW OF THE GUARDIAN SYSTEM EVENT LOG INFORMATION, NOTING "SUSPECTED PATIENT MISPOSITION" EVENTS. THE DEVICE CONTINUED TO LOG SEVERAL MISPOSITION EVENTS UNTIL THE PATIENT WAS DISCHARGED ON (B)(6) 2024, RESULTING IN 48 HOURS OF LESS THAN OPTIMAL THERAPY. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 18986318 ↗
• InjuryMar 15, 2024Gas/Air Leak; Gas/Air Leak

  PATIENT WAS DIAGNOSED WITH A STAGE 3 PRESSURE INJURY ON THE BUTTOCKS. THERE WAS NO INDICATION FROM THE USING FACILITY WHETHER FURTHER TREATMENT OR INTERVENTION WAS REQUIRED AS A RESULT. THERE WAS ALSO NO DOCUMENTATION OF THE INJURY GETTING WORSE, OR THAT ANY ADDITIONAL COMPLICATIONS OCCURRED AS A RESULT OF THE STAGE 3 PRESSURE INJURY. INVESTIGATION OF THE AVAILABLE INFORMATION NOTED A LEAK ALERT REGISTERED IN THE GUARDIAN DEVICE DURING USE BY THIS PATIENT, AND THE SYSTEM CONTINUED TO ALERT UNTIL THE PATIENT WAS TRANSFERRED DESPITE ATTEMPTS BY THE TURNCARE TEAM TO CONTACT THE BEDSIDE NURSE. THE GUARDIAN DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 18914923 ↗