CrossFlow 0450000115Recalls & reported problems
Stryker Corporation · Day-Use Inflow Cassette Tubing, Do not use if package is damaged · Class 2
All models of CrossFlow (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327261028), received between Feb 17, 2026 and Sep 30, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Increase in Pressure” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Increase in Pressure3
Patient problems
- Swelling/ Edema5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Increase in Pressure
Patient problems: Swelling/ Edema
MAUDE report 50953377 ↗MalfunctionJul 28, 2026
Patient problems: Swelling/ Edema
MAUDE report 50058142 ↗MalfunctionJul 28, 2026
Patient problems: Swelling/ Edema
MAUDE report 50058136 ↗MalfunctionMar 25, 2026Increase in Pressure
IT WAS REPORTED THAT THE PUMP SET UP AND PRIMING WERE ALL DONE CORRECTLY. WITH THE PUMP SET AT 40MM WE STARTED THE CASE. THE PATIENT'S KNEE STARTED TO BLOW UP ALMOST IMMEDIATELY. WE STOPPED AND GOT A DIFFERENT PUMP AND SWITCHED THE TUBING CARTRIDGE TO THE SECOND PUMP. SAME THING WAS HAPPENING. NOW I JUST DROPPED THE PUMP PRESSURE TO 15MM AND COMPLETED THE CASE WITH NO FURTHER ISSUES. THE EXTRA SWELLING DISSIPATED OVER THE NEXT FEW DAYS POST-OP WITH NO REMAINING PATIENT ISSUES.
Patient problems: Swelling/ Edema
MAUDE report 24691773 ↗InjuryFeb 17, 2026Increase in Pressure
IT WAS REPORTED THAT DURING THE PROCEDURE, THE BLUE CASSETTE MALFUNCTIONED, RESULTING IN VARIABLE WATER PRESSURE IN THE SHOULDER (SOMETIMES TOO HIGH, SOMETIMES TOO LOW). CONSEQUENCES WERE A LONGER PROCEDURE FOR THE PATIENT AND FOR THE PRACTITIONERS. ALSO, HYPERPRESSURE IN THE PATIENT'S SHOULDER LEADING TO POST-OPERATIVE PROBLEMS.
Patient problems: Swelling/ Edema
MAUDE report 24373132 ↗
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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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