NA 0225426000WRecalls & reported problems
Stryker Corporation · CBC II · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327051278), received between Jan 12, 2017 and Jan 12, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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 18, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2017Infusion or Flow Problem; Infusion or Flow Problem
THE USER FACILITY REPORTED THAT THE DEVICE'S VACUUM STOPPED WORKING DURING A PROCEDURE. APPROXIMATELY 100ML OF BLOOD WAS COLLECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6245065 ↗
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- NA ATL2001Medtronic, Inc. · APPARATUS, AUTOTRANSFUSION1 death79 reports
- autoLog IQ™ ATLGIQMedtronic, Inc. · APPARATUS, AUTOTRANSFUSION58 reports
- OCEAN 2050-000Atrium Medical Corporation · Apparatus, Autotransfusion1 recall2 reports
- NA BTC93Medtronic, Inc. · APPARATUS, AUTOTRANSFUSION1 recall2 reports
- NA BTC98Medtronic, Inc. · APPARATUS, AUTOTRANSFUSION1 recall0 reports
- HAEMONETICS CELL SAVER ELITE SYSTEM CSE-P-125Haemonetics Corporation · Apparatus, Autotransfusion47 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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