CrossFlow 0450000200Recalls & reported problems
Stryker Corporation · Outflow 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327055214), received between Jun 23, 2023 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Expiration Date Error” (1 report).
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
- Expiration Date Error1
- Increase in Pressure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Increase in Pressure
Patient problems: Swelling/ Edema
MAUDE report 50953977 ↗MalfunctionJun 23, 2023Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17192923 ↗
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- 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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