Monoject 8881245164Recalls & reported problems
Cardinal Health, Inc. · Sternal-Iliac Aspiration Needle,I-Type · Class 1
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521020474), received between Nov 28, 2017 and Jan 2, 2018 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break3
Patient problems
- Foreign Body In Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2018Break; Break
THE CUSTOMER STATES THAT THE NEEDLE SEPARATED OR BROKE OFF WHERE IT ATTACHED TO THE HANDLE WHEN IT WAS BEING REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7158428 ↗InjuryNov 29, 2017Break; Break
THE CUSTOMER REPORTS THAT THE BONE MARROW NEEDLE BROKE DURING A PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 7069428 ↗InjuryNov 28, 2017Break; Break
THE CUSTOMER REPORTS THAT THE BONE MARROW ASPIRATE NEEDLE BROKE OFF IN THE PATIENT'S ILIAC CREST DURING A PROCEDURE. FORCEPS WERE USED TO PULL OUT THE BROKEN PIECE.
Patient problems: Foreign Body In Patient
MAUDE report 7064542 ↗
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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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