Prime Series 1115 (REF 1115-000-000XE)Recalls & reported problems
Stryker Corporation · Class 2
All models of Prime Series (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Prime Series 1115 wheeled stretcher is used to move patients in hospitals. Its 59 reports mostly describe mechanical trouble: parts jamming, fluid or blood leaking out, electrical and grounding problems, exposed sharp metal edges, and the stretcher or its IV pole slipping or falling. One injury is reported and no deaths. No recalls name this device. Reports dropped from 14 in the earlier 12 months to 2 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 07613327278255), received between Oct 26, 2018 and Jan 26, 2026 — classified as 1 injury, 58 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (16 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 Jam16
- Fluid/Blood Leak10
- Electrical /Electronic Property Problem9
- Device Slipped6
- Grounding Malfunction6
- Device Fell4
- Sharp Edges4
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Patient Involvement9
- Reaction1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Device Fell
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1-DECEMBER 31, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED IV POLE FALLS FROM UPRIGHT POSITION IN AN UNINTENDED DIRECTION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24181464 ↗MalfunctionJan 26, 2026Device Slipped
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24180195 ↗MalfunctionOct 27, 2025Sharp Edges; Sharp Edges
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP EDGES EXPOSED (METAL). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393631 ↗MalfunctionOct 27, 2025Grounding Malfunction; Grounding Malfunction
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED GROUND PATH COMPROMISED. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393623 ↗MalfunctionOct 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT NOW SUMMARIZES 0 MALFUNCTION EVENTS(S), INSTEAD OF 1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393061 ↗MalfunctionApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKS ONTO FLOOR. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21912132 ↗MalfunctionApr 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES 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 21911787 ↗MalfunctionApr 25, 2025Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21911529 ↗MalfunctionJan 30, 2025Grounding Malfunction; Grounding Malfunction
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED A COMPROMISED GROUND PATH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21273437 ↗MalfunctionJan 30, 2025Device Slipped; Device Slipped
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED THE MATTRESS SLIDING OFF THE LITTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21273425 ↗MalfunctionJan 27, 2025Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241350 ↗MalfunctionJan 27, 2025Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES WHICH WERE DIFFICULT TO ENGAGE OR DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241349 ↗MalfunctionJan 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENT(S), 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 21241348 ↗MalfunctionJan 24, 2025Device Slipped; Device Slipped
IT WAS REPORTED THAT WHILE LIFTING / LOADING A PATIENT ONTO A STRETCHER, THE MATTRESS ALLEGEDLY MOVED/SLID OFF THE STRETCHER, THE PATIENT WAS NOT INJURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21233314 ↗MalfunctionJan 24, 2025Device Slipped; Device Slipped
IT WAS REPORTED THAT WHILE LIFTING / LOADING A PATIENT ONTO A STRETCHER, THE MATTRESS ALLEGEDLY MOVED/SLID OFF THE STRETCHER, THE PATIENT WAS NOT INJURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21233313 ↗MalfunctionJan 24, 2025Device Slipped; Device Slipped
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21233312 ↗MalfunctionOct 25, 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 20537308 ↗MalfunctionOct 25, 2024Electrical /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 20534677 ↗MalfunctionOct 25, 2024Mechanical 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 20534179 ↗MalfunctionJul 26, 2024Grounding Malfunction; Grounding Malfunction
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED GROUND PATH COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19837235 ↗MalfunctionJul 25, 2024Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE, BRAKES CANNOT BE ENGAGED OR STEER DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19831831 ↗MalfunctionJul 25, 2024Fluid/Blood Leak; Grounding Malfunction; Fluid/Blood Leak; Grounding Malfunction
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKS ONTO FLOOR AND GROUND PATH COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19831760 ↗MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19831755 ↗MalfunctionJul 25, 2024Mechanical Problem; Mechanical Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED REDUCED/INADEQUATE BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19831716 ↗MalfunctionJun 26, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE POWER CORD HAD ACCESSIBLE AC CURRENT. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19619535 ↗
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.
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