JamshidiRecalls & reported problems across all models

We found 5 models of Jamshidi by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2021 and Jul 20, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Jamshidi recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 23, 2021Open, Classified

   Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

   Z-2248-2021 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Jamshidi problems

Jamshidi models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Jamshidi EJM4011

  INSTRUMENT, BIOPSY
  1 recall9 reports
• Jamshidi EJC4008

  INSTRUMENT, BIOPSY
  1 report
• Jamshidi EJC4011

  INSTRUMENT, BIOPSY
  1 report
• Jamshidi EJM3513

  INSTRUMENT, BIOPSY
  1 report
• Jamshidi EJM6011

  INSTRUMENT, BIOPSY
  1 report

Recent Jamshidi adverse event reports

The 13 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876584 ↗
• MalfunctionMay 8, 2026Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A JAMSHIDI BONE MARROW BIOPSY PROCEDURE, AFTER EJECTING THE CORE FROM THE CANNULA, THE PHYSICIAN NOTICED THAT A SMALL PIECE OF METAL CAME OUT BEHIND IT. NO PATIENT HARM WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT A METAL FRAGMENT MEASURING LESS THAN 1 CM WITH A ROUNDED SHAPE WAS OBSERVED. THERE WAS NO REPORTED IMPACT TO THE PATIENT, HEALTHCARE PROVIDER, USER, OR OTHERS, AND NO MEDICAL INTERVENTION, DIAGNOSTICS, PROCEDURES, OR TREATMENT DELAYS WERE REQUIRED. THE JAMSHIDI NEEDLE WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), AND NO DIFFICULTY OR RESISTANCE WAS NOTED DURING USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131149 ↗
• MalfunctionFeb 20, 2026Nonstandard Device

  IT WAS REPORTED THAT ON (B)(6), 2025. THE JAMSHIDI NEEDLE INNER STYLET DISENGAGED FROM THE HANDLE CAUSING IT TO GET STUCK AND THEY HAD TO USE A FORCEPS TO REMOVE THE INNER STYLET RESULTING IN PROLONGED PROCEDURE, SPECIMEN NOT COLLECTED APPROPRIATELY. A NEW NEEDLE HAD TO BE USED. BASED ON FOLLOW UP RESPONSE RECEIVED ON 30-JAN-2026 IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED DURING ADVANCING THE DEVICE INSIDE THE PATIENT DURING THE BONE MARROW BIOPSY PROCEDURE, AS A RESULT ONLY PARTIAL SPECIMEN WAS COLLECTED. THE PARTIAL SAMPLE WAS SENT FOR ANALYSIS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24407815 ↗
• MalfunctionJan 21, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT WHEN CONNECTING A LUER LOCK SYRINGE TO THE TOP OF SUCTION PORT, IT DID NOT CREATE A SEAL. DIFFERENT TYPES OF SYRINGES WERE USED, REINSERTION OF NEW JAMSHIDI NEEDLE CAUSING A LONGER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131573 ↗
• MalfunctionNov 12, 2025Contamination; Contamination

  IT WAS REPORTED THAT ON 16-OCTOBER-2025, THE JAMSHIDI NEEDLE HAD A PACKAGE ISSUE AS THERE WAS BLUE COLOR SHOWING INSIDE THE PACKAGE. THE ISSUE WAS REPORTED TO BE DETECTED DURING INSTALLATION; HOWEVER, IT WAS ALSO REPORTED THAT THE AFFECTED PRODUCT WAS NOT USED ON A PATIENT. FURTHERMORE, THERE WAS NO IMPACT TO THE PATIENT REPORTED. BASED ON FOLLOW UP RESPONSE, IT WAS FURTHER CONFIRMED THAT THERE WAS NO PATIENT HARM AND THAT THE ISSUE WAS IDENTIFIED WHEN THE PACKAGED WAS BEING OPENED. THE DOCTOR RETURNED TO THE PURCHASE DEPARTMENT PRIOR TO BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533003 ↗
• 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 ↗
• MalfunctionJul 14, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING THE BONE MARROW BIOPSY PROCEDURE DURING USE OF THE JAMSHIDI NEEDLE, SOME THIN LAYER PEELED AWAY FROM THE NEEDLE AFTER THE NEEDLE WAS REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT TWO CORE SAMPLES WERE OBTAINED WITH THE SAME NEEDLE, BUT ONE CORE SAMPLE WAS FRAGMENTED. DESPITE THESE ISSUES THE CORE SAMPLES WERE COLLECTED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493968 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A BONE MARROW BIOPSY PROCEDURE, THE WHITE CAP/HANDLE PART OF THE CRADLE CAME OFF. IT WAS FURTHER REPORTED THAT FORCEPS WERE USED TO REMOVE THE DEVICE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAD AN INCIDENT DURING A BONE MARROW PROCEDURE WITH ITEM# EJM4011. WHEN THE PHYSICIAN ASSISTANT WAS COLLECTING THE BIOPSY, THE WHITE CAP/HANDLE PART OF THE CRADLE CAME OFF. THEY WERE ABLE TO USE FORCEPS TO GRIP THE PART AND REMOVE FROM THE PATIENT. LOT NUMBER: 0001578725. DATE OF MANUFACTURER: 2024-07-18.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859105 ↗
• 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 ↗
• MalfunctionApr 12, 2022Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER REPORTED THAT TWO OF 10 PACKAGES WERE OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083944 ↗
• MalfunctionFeb 3, 2022Packaging Problem; Packaging Problem

  THIS IS A REPORT ABOUT AN OPEN PACKAGE. ACCORDING TO THE CUSTOMER'S REPORT, THE PACKAGE WAS FOUND TO BE OPEN BEFORE USE, AND THIS PRODUCT WAS THUS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446347 ↗
• MalfunctionNov 12, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES. VERBATIM: IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES DESCRIBE THE EVENT OR PROBLEM: IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES. MANUFACTURER RESPONSE FOR BONE MARROW BIOPSY NEEDLE, (BRAND NOT PROVIDED) (PER SITE REPORTER) : NONE YET. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : BONE MARROW BIOPSY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804133 ↗
• InjuryNov 12, 2021Break; Break

  IT WAS REPORTED THAT DURING A BONE MARROW BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT A METAL STRAW PIECE FROM THE DEVICE PUNCTURED THE FINGER OF THE HCP AND AS A RESULT STARTED BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT WAS NOT INJURED AND THE HCP WAS NOTED TO BE IN A STABLE CONDITION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12804026 ↗

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