Jamshidi EJM6011Recalls & reported problems
Bard Peripheral Vascular, Inc. · JAMSHIDI EVOLVE BONE MARROW BIOPSY/ASPIRATION NEEDLE 11GX6 CRADLE · 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 10885403464171), received between Apr 13, 2023 and Apr 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling 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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Markings/Labelling Problem1
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.
MalfunctionApr 13, 2023Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available; Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available
MATERIAL NO: EJM6011. IT WAS REPORTED BY THE CUSTOMER THEY RECEIVED THREE BOXES OF PRODUCT BUT IT HAD THE WRONG SIZE DESCRIPTION ON THE LABEL. THE PRODUCT WAS LABELED FOR SIZE 11GX15CM BUT SHOULD HAVE BEEN FOR 11GX6CM. VERBATIM: THIS CUSTOMER RECEIVED 3 BOXES OF EJM6011 WHICH SHOULD BE AN 11G X 6CM. HOWEVER, THE PACKAGING SAYS EJM6011 BUT IT HAS DESCRIPTION LISTED AT 11GX15CM. PICTURES ATTACHED. CAN YOU PLEASE ASSIST WITH GETTING CREDIT BACK TO MY SAMPLE ACCOUNT? OMITTED ALREADY SENT THE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16731840 ↗
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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