CrossFlowRecalls & reported problems across all models
Stryker Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 118
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls
- 0
We found 6 models of CrossFlow by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 118 adverse event reports in the FDA's MAUDE database, received between May 25, 2018 and Sep 30, 2026 — classified as 39 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Increase in Pressure” (50 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CrossFlow problems
Device problems
- Increase in Pressure50
- Adverse Event Without Identified Device or Use Problem17
- Pressure Problem15
- Failure to Deliver8
- Pumping Problem6
- Electrical Shorting4
- Improper Flow or Infusion4
- Inaccurate Flow Rate4
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- Swelling/ Edema36
- Extravasation26
- No Known Impact Or Consequence To Patient18
- Insufficient Information5
- No Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Burn(s)1
CrossFlow models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CrossFlow 0450000000ARTHROSCOPE106 reports
- CrossFlow 0450000115ARTHROSCOPE5 reports
- CrossFlow 0450000100ARTHROSCOPE3 reports
- CrossFlow 0450000200ARTHROSCOPE2 reports
- CrossFlow 0450000300ARTHROSCOPE1 report
- CrossFlow 0450000125ARTHROSCOPE1 report
Recent CrossFlow adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Increase in Pressure
Patient problems: Swelling/ Edema
MAUDE report 50953977 ↗MalfunctionSep 30, 2026Increase in Pressure
Patient problems: Swelling/ Edema
MAUDE report 50953384 ↗MalfunctionSep 30, 2026Increase in Pressure
Patient problems: Swelling/ Edema
MAUDE report 50953383 ↗MalfunctionSep 30, 2026Increase in Pressure
Patient problems: Swelling/ Edema
MAUDE report 50953377 ↗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 28, 2026
Patient problems: Swelling/ Edema
MAUDE report 50058142 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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