Prime Series 1115EHT3Recalls & reported problems
Stryker Corporation · Class 2
All models of Prime Series (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327356090), received between Jan 25, 2019 and Apr 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Grounding Malfunction” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Grounding Malfunction1
- Mechanical Jam1
- No Audible Alarm1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2024No Audible Alarm; No Audible Alarm
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL CONDITION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19155802 ↗MalfunctionApr 26, 2019Grounding Malfunction; Grounding Malfunction
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE GROUND PRONG WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8554612 ↗MalfunctionJan 25, 2019Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE 5TH WHEEL WAS DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8279169 ↗
Other STRETCHER, WHEELED devices
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- Procedural stretcher P8000HHill-Rom de México, S. de R.L. de C.V. · STRETCHER, WHEELED361 reports
- Prime Series 1115Stryker Corporation · STRETCHER, WHEELED1 death251 reports
- Prime Series 1115Stryker Corporation · STRETCHER, WHEELED1 recall199 reports
- Power-PRO 2, High Configuration 650705550001Stryker Corporation · STRETCHER, WHEELED2 recalls2 deaths99 reports
- NA 1089Stryker Corporation · STRETCHER, WHEELED175 reports
- NA 5050Stryker Corporation · STRETCHER, WHEELED1 recall99 reports
- Power-PRO 2 650700000000Stryker Corporation · STRETCHER, WHEELED2 recalls1 death42 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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