Jamshidi EJC4011Recalls & reported problems
Bard Peripheral Vascular, Inc. · JAMSHIDI EVOLVE BONE MARROW BIOPSY/ASPIRATION NEEDLE 11GX4 · Class 2
All models of Jamshidi (5)
Data updated Oct 16, 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 10885403464065), received between Nov 10, 2025 and Nov 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole1
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.
MalfunctionNov 10, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE OPENING AND THE COLLECTION SYRINGE DID NOT BUILD UP NEGATIVE PRESSURE, SO THAT NO LIQUID BONE MARROW COULD BE OBTAINED. THE INCIDENT OCCURRED DURING USE. THREE NEEDLES FROM TWO DIFFERENT BOXES FROM THIS BATCH FOR THE BONE MARROW PUNCTURES AND NO NEGATIVE PRESSURE COULD BE BUILT UP VIA THE OPENING AND THE EXTRACTION SYRINGE, SO THAT NO LIQUID BONE MARROW COULD BE OBTAINED. ALTERNATIVE PUNCTURE NEEDLES FROM ANOTHER COMPANY WERE AVAILABLE AND WERE SUCCESSFULLY USED FOR THE PROCEDURE. THERE WAS NO PATIENT HARM WAS REPORTED. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED, AND THERE WERE NO DELAYS IN DIAGNOSTICS, TREATMENT, OR PROCEDURES. DURING THE INVESTIGATION, THE SAMPLE ANALYSIS OBSERVED A HOLE IN THE WELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513039 ↗
Other INSTRUMENT, BIOPSY devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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