Bone Marrow Harvest Needle BMHN1104VXRecalls & reported problems
Argon Medical Devices, Inc. · Bone Marrow Harvest Needle 11ga x 4in · 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 00886333007660), received between Oct 1, 2020 and Oct 1, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 1, 2020Material Deformation
PHYSICIAN STATEMENT: AFTER THE INITIAL INSERTION OF THE HARVEST NEEDLE INTO THE PATIENT (HARD BONE), THE STYLET WAS REMOVED, AND ASPIRATION WAS SUCCESSFUL. THE STYLET WAS REINSERTED, AND THE NEEDLE WAS ADVANCED WITH SECOND ASPIRATION. THE PROCESS WAS REPEATED AGAIN. AFTER THE THIRD ASPIRATE, THE STYLET WAS AGAIN REINSERTED, AND NEEDLE ENTIRELY REMOVED. PRIOR TO REINSERTION FOR THE SECOND PUNCTURE OF THE PROCEDURE, THE PHYSICIAN NOTICED THE SHORTENED SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10611441 ↗
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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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