Prime Series 1105 (REF 1105-000-000XE)Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327278224), received between Apr 26, 2019 and Apr 23, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (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. 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
- Mechanical Jam3
- Fluid/Blood Leak2
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19162865 ↗MalfunctionOct 24, 2023Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17998834 ↗MalfunctionJan 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16210094 ↗MalfunctionJul 27, 2021Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES CANNOT BE ENGAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12234514 ↗MalfunctionJul 22, 2020Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE BRAKES WERE DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10308959 ↗MalfunctionApr 26, 2019Device Slipped; Device Slipped
THIS REPORT SUMMARIZES <NOE> 6 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE MATTRESS SLIPPED OFF THE LITTER. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WERE NO CONSEQUENCES OR IMPACTS TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8555198 ↗
Other STRETCHER, WHEELED devices
- Power-PRO 6506Stryker Corporation · STRETCHER, WHEELED5 deaths472 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page