FloSteady 0350800001Recalls & reported problems
Stryker Corporation · Arthroscopy Pump, Model 150 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327057522), received between May 24, 2018 and Nov 30, 2022 — classified as 3 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Pressure Problem7
- Increase in Pressure5
- Pumping Problem4
- Adverse Event Without Identified Device or Use Problem3
- Electrical Shorting1
- Fluid/Blood Leak1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient3
- Edema2
- Extravasation1
- Insufficient Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2022Electrical Shorting; Electrical Shorting
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15890528 ↗MalfunctionFeb 18, 2022Increase in Pressure; Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THERE WAS OVERPRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13562647 ↗InjuryNov 1, 2021Pressure Problem; Adverse Event Without Identified Device or Use Problem; Pressure Problem
IT WAS REPORTED THAT THERE WAS EXTRAVASATION.
Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions
MAUDE report 12733757 ↗MalfunctionJul 7, 2021Increase in Pressure; Pumping Problem; Pumping Problem
IT WAS REPORTED THAT THE PRESSURE WAS HIGHER THAN INTENDED. THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12132291 ↗MalfunctionJul 7, 2021Increase in Pressure; Pumping Problem; Pumping Problem
IT WAS REPORTED THAT THE PRESSURE WAS HIGHER THAN INTENDED. THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12132248 ↗MalfunctionJul 7, 2021Increase in Pressure; Pumping Problem; Pumping Problem
IT WAS REPORTED THAT THE PRESSURE WAS HIGHER THAN INTENDED. THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12132247 ↗MalfunctionJul 7, 2021Increase in Pressure; Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE PRESSURE WAS HIGHER THAN INTENDED. THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12132240 ↗MalfunctionMar 31, 2021Pressure Problem; Pumping Problem; Pumping Problem
IT WAS REPORTED THAT THERE WAS OVERPRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11597571 ↗InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Pressure Problem; Pressure Problem
InjurySep 30, 2019Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak
MalfunctionJul 23, 2018Smoking
IT WAS REPORTED THAT THE DEVICE BEGAN SMOKING DURING THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7712833 ↗MalfunctionMay 24, 2018Pressure Problem
IT WAS REPORTED THAT OVER-PRESSURE WAS EXPERIENCED WITH THE PUMP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7543099 ↗MalfunctionMay 24, 2018Pressure Problem
IT WAS REPORTED THAT OVER-PRESSURE WAS EXPERIENCED WITH THE PUMP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7543098 ↗
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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