CrossFlow 0450000000Recalls & reported problems
Stryker Corporation · Integrated Arthroscopy Pump · Class 2
Quick summary
This Stryker CrossFlow integrated arthroscopy pump supplies fluid during joint surgery. Its 99 adverse event reports include no deaths, 38 injuries and 61 malfunctions. The reports mostly describe joint pressure rising above the set level, fluid leaking into surrounding tissue, and swelling after shoulder arthroscopy, with some surgeries delayed by error messages. Reports in the last 12 months number 18, up from 7 in the year before. No recalls name this device.
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
- 106
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 07613327058048), received between May 25, 2018 and Sep 30, 2026 — classified as 38 injuries, 68 malfunctions.
The most frequently reported specific device problem is “Increase in Pressure” (45 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
- Increase in Pressure45
- Adverse Event Without Identified Device or Use Problem17
- Pressure Problem15
- Failure to Deliver7
- Pumping Problem6
- Electrical Shorting4
- Improper Flow or Infusion4
- Inaccurate Flow Rate4
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- Swelling/ Edema29
- Extravasation26
- No Known Impact Or Consequence To Patient17
- Insufficient Information5
- No Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Burn(s)1
Recent adverse event reports
The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Increase in Pressure
Patient problems: Swelling/ Edema
MAUDE report 50953384 ↗MalfunctionSep 29, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940049 ↗MalfunctionSep 17, 2026Increase in Pressure
Patient problems: Swelling/ Edema
MAUDE report 50810406 ↗MalfunctionSep 17, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810272 ↗MalfunctionSep 15, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782305 ↗MalfunctionAug 31, 2026Increase in Pressure
It was reported that the pressure in the joint is higher than the pressure set on the pump. The shoulder joints are swelling.
Patient problems: Swelling/ Edema
MAUDE report 50524112 ↗MalfunctionAug 18, 2026Smoking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310942 ↗MalfunctionAug 14, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261813 ↗MalfunctionAug 14, 2026Increase in Pressure
Patient problems: Swelling/ Edema
MAUDE report 50245601 ↗MalfunctionAug 11, 2026Insufficient Device Problem Information
It was reported that there was an error message on the crossflow. The surgery was postponed and had to wake the patient up.
Patient problems: Insufficient Information
MAUDE report 50202652 ↗InjuryJul 28, 2026Increase in Pressure
It was reported that at the end of the shoulder arthroscopy procedure, the patient was flipped supine on the OPERATING ROOM table, and noticeable fluid swelling was observed on the patient's operative side neck and through his entire chest. It was then decided to transfer the patient to the ICU until the airway swelling went down and could be safely extubated. The patient unable to be discharged as originally scheduled as they needed to be reintubated and sent to the ICU.
Patient problems: Swelling/ Edema
MAUDE report 50063461 ↗MalfunctionJul 27, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50002228 ↗MalfunctionJul 27, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50002227 ↗MalfunctionMay 21, 2026Failure to Deliver
IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY THERE WAS NO PRESSURE BUILD-UP WITH THE DEFAULT SETTINGS ON THE CROSSFLOW PUMP AND A DAILY CASSETTE IN INFLOW-OUTFLOW MODE. THE TUBING SYSTEMS WERE REPLACED. INITIALLY SET TO THE SAME BATCH, BUT NO CHANGE IN THE SITUATION. ONLY BY INCREASING THE PRESSURE (70 MMHG+) AND THE FLOW (HIGH) COULD THE PROCEDURE BE CONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25248003 ↗MalfunctionMay 21, 2026Failure to Deliver
IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY THERE WAS NO PRESSURE BUILD-UP WITH THE DEFAULT SETTINGS ON THE CROSSFLOW PUMP AND A DAILY CASSETTE IN INFLOW-OUTFLOW MODE. THE TUBING SYSTEMS WERE REPLACED. INITIALLY SET TO THE SAME BATCH, BUT NO CHANGE IN THE SITUATION. ONLY BY INCREASING THE PRESSURE (70 MMHG+) AND THE FLOW (HIGH) COULD THE PROCEDURE BE CONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25248002 ↗MalfunctionFeb 26, 2026Increase in Pressure
IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY, THERE WAS INCREASED INTRAOPERATIVE SWELLING OF THE SHOULDER WITHOUT ANY CHANGES TO THE BASIC SETTINGS OF THE CROSSFLOW PUMP. TWO HOURS AFTER THE SURGICAL PROCEDURE, THE SWELLING HAD SIGNIFICANTLY SUBSIDED, AND THE PATIENT NO LONGER EXPERIENCED ANY FURTHER COMPLAINTS. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Swelling/ Edema
MAUDE report 24459139 ↗MalfunctionFeb 12, 2026Increase in Pressure
IT WAS REPORTED THAT THE CROSSFLOW DOES NOT CALIBRATE THE PRESSURE CORRECTLY. THE FILLING PROCESS IS SKIPPED IMMEDIATELY. IF YOU THEN REMOVE THE CARTRIDGE AND START THE PROCESS AGAIN FROM THE BEGINNING, IT WORKS, BUT THE PRESSURE IS MUCH TOO HIGH. SOMETIMES THE FILLING PROCESS WORKS, BUT AS SOON AS IT IS COMPLETE, NO WATER RUNS, SO YOU HAVE TO START THE PROCESS AGAIN FROM THE BEGINNING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24328259 ↗InjuryJan 13, 2026Increase in Pressure
IT WAS REPORTED THAT THE PUMP WAS SET VERY LOW STARTING AT 35 AND THEN BUMPING IT DOWN TO 15 BUT PUMP SEEMED TO BE PUMPING VERY HARD EVEN WITH LOWERING PRESSURE. AFTER THE CASE THE PATIENT EXPERIENCED A LOT OF SWELLING AND HAD TO BE ADMITTED UNTIL THEY RECOVERED. PATIENT HAD TO STAY THE NIGHT TO MONITOR THE SWELLING.
Patient problems: Swelling/ Edema
MAUDE report 24059219 ↗MalfunctionJan 12, 2026Increase in Pressure
IT WAS REPORTED THAT THE PRESSURE OF THE PUMP DOES NOT MATCH THE PRESSURE IN THE JOINT. AT A PRESSURE OF 15, THE WATER SQUIRTS OUT OF THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24046181 ↗MalfunctionDec 30, 2025Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THERE WERE PRIMING ISSUES WHERE THEY CLICKED THE PRIME BUTTON AND NO WATER CAME OUT. THEN WHEN IT DID WORK, IN THE MIDDLE OF THE CASE, THE FLUID JUST STOPPED COMING OUT OF THE INFLOW INTO THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927641 ↗InjuryDec 23, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE PRESSURE OF THE IRRIGATION FLUID WAS PRESUMABLY TOO HIGH. THE PRESSURE (PUMP SETTING) WAS REDUCED SEVERAL TIMES DURING THE PROCEDURE AND WAS ULTIMATELY SET TO 15 MMHG. THERE WAS SEVERE FLUID INFILTRATION OF THE LEG FROM THE KNEE DOWN ACROSS THE ENTIRE LOWER LEG. AFTER THE PROCEDURE, NO FOOT PULSES WERE PALPABLE AND COULD NOT BE DETECTED WITH DOPPLER EITHER. THERE WAS PROLONGED ANESTHESIA DURATION OF APPROXIMATELY 20 MINUTES. A CT ANGIOGRAPHY WAS SUBSEQUENTLY PERFORMED. AFTER 3 WEEKS, NO PERMANENT DAMAGE WAS DETECTABLE. THERE WAS NO OTHER MEDICAL TREATMENTS AND THE PATIENT IS FINE NOW AND HAS NO LONG-TERM SIDE EFFECTS.
Patient problems: Extravasation; Swelling/ Edema
MAUDE report 23885297 ↗MalfunctionDec 23, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT DESPITE SET PRESSURE BEING MET, THE FLOW CONTINUES CAUSING SWELLING IN THE JOINT.
Patient problems: Swelling/ Edema
MAUDE report 23883510 ↗MalfunctionDec 18, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT THE DEVICE CAUSED SWELLING IN THE PATIENT'S SHOULDER.
Patient problems: Swelling/ Edema
MAUDE report 23842565 ↗MalfunctionDec 9, 2025Failure to Deliver; Improper Flow or Infusion; Failure to Deliver; Improper Flow or Infusion
IT WAS REPORTED THAT THE CROSSFLOW STOPPED FLOWING MID CASE. IT DID IT AGAIN AFTER RESTARTING AND REPRIMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23762481 ↗MalfunctionNov 26, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT WHILE USING THE CROSSFLOW, THE SHOULDER PRESSURE WAS TOO HIGH. THE PRESSURE WAS SET TO 35 THEN 25 BUT THE SHOULDER EXPANDED LARGER THAN IT SHOULD HAVE.
Patient problems: Swelling/ Edema
MAUDE report 23660691 ↗
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.