IsoTour 2874Recalls & reported problems
Stryker Corporation · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327471427), received between Apr 25, 2022 and Jul 25, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem3
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22608934 ↗MalfunctionJul 19, 2023Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17350153 ↗MalfunctionApr 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16815505 ↗MalfunctionApr 25, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED EXPOSED BARE WIRES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14193781 ↗
Other MATTRESS, FLOTATION THERAPY, NON-POWERED devices
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- DRIVEMEDICAL 6500-DE-2-FBDrive Devilbiss Healthcare · MATTRESS, FLOTATION THERAPY, NON-POWERED1 report
- PrevaMatt 253-3680Joerns Healthcare, LLC · Mattress, Flotation Therapy, Non-Powered1 report
- DRIVEMEDICAL SSP216DDA-ELRDrive Devilbiss Healthcare · MATTRESS, FLOTATION THERAPY, NON-POWERED1 report
- Drive 15970-4280Drive Devilbiss Healthcare · MATTRESS, FLOTATION THERAPY, NON-POWERED1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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