Monoject 8881247137Recalls & reported problems
Cardinal Health, Inc. · Bone Marrow Biopsy / Aspiration Needle,J-Type · Class 1
All models of Monoject (164)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521020511), received between Jun 13, 2017 and Jun 13, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2017Break; Break
THE CUSTOMER STATES WE HAVE HAD MULTIPLE SAFETY INCIDENTS OF MONOJECT (ASPIRATE) NEEDLES , WHERE THE METAL NEEDLES SEPARATED FROM PLASTIC HANDLES. THE METAL NEEDLES THEMSELVES REMAINED INTACT. DELAY IN CARE, EXTENDED ANESTHESIA TIME, AND SECONDARY PUNCTURE FOR BMA/BIOPSY AFTER SUCCESSFUL MANIPULATION AND REMOVAL OF METAL NEEDLE SHEATH AND INNER NEEDLE. NO PATIENT INJURY IN EITHER CASE. PROCEDURES WERE ABLE TO BE COMPLETED.
Patient problems: Foreign Body In Patient
MAUDE report 6637656 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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