Isolibrium 2971Recalls & reported problems
Stryker Corporation · Class 2
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327278392), received between May 7, 2018 and Oct 27, 2020 — classified as 9 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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
Device problems
- Insufficient Device Problem Information7
- Adverse Event Without Identified Device or Use Problem1
- Device Operates Differently Than Expected1
- Device Slipped1
- Patient-Device Incompatibility1
Patient problems
- Pressure Sore/Ulcer6
- Injury3
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2020Device Slipped; Device Slipped
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE DRIFTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10741484 ↗InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem
IT IS REPORTED THAT A NURSING ASSISTANT WAS INJURED WHILE BOOSTING A HEAVY PATIENT ON AN ISOLIBRIUM SURFACE. THE SEVERITY OF THE ALLEGED INJURY IS NOT KNOWN.
Patient problems: Injury
MAUDE report 8691918 ↗MalfunctionMay 14, 2018Device Operates Differently Than Expected
IT WAS REPORTED THAT DURING AN INSERVICE AT THE ACCOUNT THAT A CPR BACK BOARD WAS PULLED FROM A CODE CART AND IT WAS IDENTIFIED THAT THE BACKBOARD COULD BE DIFFICULT TO SLIDE UNDER THE MATTRESS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7510499 ↗InjuryMay 10, 2018Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT DEVELOPED A STAGE 3 PRESSURE INJURY WHILE ON THE MATTRESS. THE NURSE MANAGER REPORTED THE INJURY WAS TREATED USING VENELEX.
Patient problems: Pressure Sore/Ulcer
MAUDE report 7503572 ↗InjuryMay 10, 2018Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT DEVELOPED A STAGE 3 PRESSURE INJURY WHILE ON THE MATTRESS. THE NURSE MANAGER REPORTED THE INJURY WAS TREATED USING VENELEX.
Patient problems: Pressure Sore/Ulcer
MAUDE report 7503479 ↗InjuryMay 10, 2018Patient-Device Incompatibility
IT WAS REPORTED THE PATIENT DEVELOPED A STAGE 3 PRESSURE INJURY WHILE ON THE MATTRESS. THE NURSE MANAGER REPORTED THE INJURY WAS TREATED USING VENELEX..
Patient problems: Injury
MAUDE report 7503477 ↗InjuryMay 10, 2018Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT DEVELOPED A STAGE 2 PRESSURE INJURY WHILE ON THE MATTRESS. THE NURSE MANAGER REPORTED THE INJURY WAS TREATED USING VENELEX.
Patient problems: Pressure Sore/Ulcer
MAUDE report 7503470 ↗InjuryMay 10, 2018Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT DEVELOPED A STAGE 2 PRESSURE INJURY WHILE ON THE MATTRESS. THE NURSE MANAGER REPORTED THE INJURY WAS TREATED USING VENELEX
Patient problems: Pressure Sore/Ulcer
MAUDE report 7503468 ↗InjuryMay 10, 2018Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT DEVELOPED A STAGE 1 PRESSURE INJURY WHILE ON THE MATTRESS. THE NURSE MANAGER REPORTED THE INJURY WAS TREATED USING VENELEX.
Patient problems: Pressure Sore/Ulcer
MAUDE report 7503466 ↗InjuryMay 10, 2018Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT DEVELOPED A STAGE 3 PRESSURE INJURY WHILE ON THE MATTRESS. THE NURSE MANAGER REPORTED THE INJURY WAS TREATED USING VENELEX..
Patient problems: Pressure Sore/Ulcer
MAUDE report 7503465 ↗InjuryMay 7, 2018Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT DEVELOPED A DEEP TISSUE INJURY WHILE ON THE SURFACE.
Patient problems: Injury
MAUDE report 7492186 ↗
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- Isolibrium 2972Stryker Corporation · BED, PATIENT ROTATION, POWERED1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.