Jamshidi DJ4011XRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885403087141), received between Jan 4, 2021 and Apr 1, 2026 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A METAL FRAGMENT WAS NOTED ON THE SPECIMEN UPON TRANSFER TO SPECIMEN CONTAINER POST REMOVAL FROM THE PATIENT. THERE WAS NO DEFECT NOTED ON THE JAMSHIDI BONE MARROW NEEDLE. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE FAILURE DID NOT CAUSE A TISSUE MISDIAGNOSIS, AND THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE METAL WAS REMOVED FROM THE SPECIMEN, AND THE HEALTH CARE PROVIDE ENSURED THERE WAS NO FOREIGN MATTER LEFT IN THE PATIENT. IT WAS CONFIRMED BY THE CUSTOMER THAT THE PATIENT WAS NOT INJURED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758832 ↗
• MalfunctionFeb 4, 2026Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT JAMSHIDI BONE MARROW ITEM WAS FOUND TO BE DEFECTIVE WHEN ATTEMPTING TO USE IT IN THE CENTRAL PROCESSING ROOM. THIS COMPLAINT IS ABOUT TISSUE SAMPLING FAILURE BEFORE USE. DURING THE FOLLOWUP RESPONSE, IT WAS FURTHER REPORTED THAT THE AFFECTED PRODUCT WAS NOT USED, AS THE DEFECT WAS NOTICED PRIOR USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259552 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT ON (B)(6) 2025, WHEN THE JAMSHIDI WAS INSERTED, NEEDLE THERE WAS SOME LEAKAGE SO NOT ABLE TO ASPIRATE. NO PATIENT HARM WAS REPORTED. THE CLINICIAN USED ANOTHER JAMSHEDI NEEDLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622653 ↗
• InjuryJun 19, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE PATIENT WAS HAVING A BONE MARROW BIOPSY AND THE NEEDLE BROKE OFF INSIDE THE PATIENT'S BONE IN HIS HIP. UNABLE TO REMOVE. ORTHOPEDIC CONSULT MADE. VERBATIM: PATIENT WAS HAVING A BONE MARROW BIOPSY AND THE NEEDLE BROKE OFF INSIDE THE PATIENT'S BONE IN HIS HIP. UNABLE TO REMOVE. ORTHOPEDIC CONSULT MADE. DESCRIBE PATIENT / (HCP) / USER IMPACT: ACTUAL / POTENTIAL ADVERSE OUTCOME/MODERATE INJURY REQUIRING MEDICAL TREATMENT. PROVIDED LOT NUMBER 0001547644 BELONGS TO MATERIAL NUMBER DJ4011X. ASKA 06/05/2024. CUSTOMER RESPONSE RECEIVED ON 06-JUN-2024. 1. WHAT WAS THE IMPACT TO THE PATIENT? 2. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? 3. HOW WAS ITEM PIECE RETRIEVED FROM PATIENT/PROCEDURE? 4. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? 1. THE PATIENT (A CHILD), FAMILY AND PHYSICIAN EXPERIENCED GREAT DISTRESS WITH A NEEDLE BREAKING OFF IN THE PATIENT¿S BACK. THE FAMILY WAS VERY UPSET AND THE PHYSICIAN WAS HORRIFIED THAT THIS HAD HAPPENED TO A PATIENT. 2. THE PATIENT HAD TO UNDERGO AND XRAY AND CT THAT DAY. THE BONE MARROW SAMPLE WAS NOT OBTAINED SO WILL HAVE T

  Patient problems: Foreign Body In Patient

  MAUDE report 19567503 ↗
• MalfunctionSep 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, THE USER SUSPECTS NEEDLE CRACK DURING USE. IT WAS OBSERVED AIR LEAKAGE. [15 SEPT 2023] - RECEIVED AN EMAIL REPLIES FROM COMPLAINANT FOR INFORMATION REQUESTED. ANSWERS ADDED IN FOLLOW UP TAB. REFER EMAIL ATTACHED. [(B)(6)] - WAS THE NEEDLE CRACK CAUSE OF THE AIR LEAKAGE? (SOLAR-MED 14/9) YES - DID THE REPORTED ISSUE OCCUR BEFORE, DURING, OR AFTER USE? (SOLAR-MED 14/9) DURING USE. - WHAT WAS THE IMPACT TO THE PATIENT? (SOLAR-MED 14/9) NO IMPACT TO THE PATIENT, ABORT THE OPERATION ON TIME. - IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? (SOLAR-MED 14/9) DEFECT SAMPLE IS AVAILABLE. - WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? (SOLAR-MED 14/9) NO - WHERE IS THE LEAKAGE COMING FROM? (SOLAR-MED 14/9) NECK OR COLLAR AREA OF THE BONE MARROW NEEDLE. - WERE THERE AIR BUBBLES ASSOCIATED WITH THE LEAKAGE? (SOLAR-MED 14/9) YES - WAS THERE AN EXPOSURE TO BLOOD OR MEDICINES? (SOLAR-MED 14/9) NO - IF EXPOSURE TO BLOOD OR MEDICINES WHAT WAS THE ROUTE OF EXPOSURE? WHO WAS EXPOSED, THE HEALTHCARE PROVIDER OR THE PATIENT? (SOLAR-MED 14/9) N/A - WAS THE PRODUCT INOPERABLE PRIOR TO USE (SOLAR-MED 14/9) NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787860 ↗
• MalfunctionSep 6, 2023Contamination; Contamination

  DR. WAS ABOUT TO PERFORM A BONE ASPIRATION BIOPSY PROCEDURE INTO HIS PATIENT. HE OPENED THE PACKAGING AND NOTICED A RED PARTICLE INSIDE THE ADAPTER. HE REQUESTED FOR A NEW NEEDLE TO START AND FINISH THE SAID PROCEDURE. (PRODUCT IS AVAILABLE FOR RETURN.) 29-AUG-2023-DING. WAS THERE ANY PATIENT INVOLVEMENT? AS PER GLOBAL REPORTING FORM, NO PATIENT INVOLVEMENT. WHAT WAS THE IMPACT TO THE PATIENT? AS PER GLOBAL REPORTING FORM, NO PATIENT INVOLVEMENT. HOW WAS THE ISSUE RESOLVED? - REQUESTED FOR A NEW NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691393 ↗
• MalfunctionFeb 15, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A SMALL PIECE OF SHREDDED METAL WITHIN THE SHEATH. VERBATIM: NEEDLE BONE MARROW 11GX4IN 10EA/CA. A SMALL PIECE OF SHREDDED METAL WAS FOUND WITHIN THE SHEATH. COMPLAINT NOTICED: PRIOR TO USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: . PATIENT INJURY: NO. HAS HEALTH CANADA BEEN INFORMED? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379152 ↗
• InjuryDec 2, 2022Break; Break

  TODAY I GOT A BREAKAGE COMPLAINT FROM THE HEMATO-PATHO DEPARTMENT OF PGIMER FOR 2 PCS DJ4011X ORIGINAL JAMSHIDI. KINDLY FIND THE ATTACHED PIC OF THE NEEDLE AND LOT NUMBER AND KINDLY SHARE THE RECENT COMPLAINT FORM TO FILL FULL INFORMATION AND SUBMISSION. DJ4011X WES BROKEN DURING 2 BONE MARROW BIOPSY CASES, ONE BROKEN INSIDE AND REMOVED THROUGH SURGERY AND ONE WITHOUT SURGERY. WAS THE NEEDLE BROKEN DURING USE OR IDENTIFIED BEFORE USE. - ITS BROKEN DURING USE WHAT WAS THE IMPACT ON THE PATIENT? - THE NEEDLE BROKE INSIDE AND THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THE NEEDLE. IS THERE A SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? - YES. WAS THERE ANY MEDICAL INTERVENTION REQUIRED? - YES, UNDERGONE SURGERY TO REMOVE THE NEEDLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15906220 ↗
• MalfunctionMay 25, 2022Packaging Problem; Packaging Problem

  THIS IS A REPORT ABOUT A HOLE ON THE PACKAGE. ACCORDING TO THE CUSTOMER'S REPORT, A HOLE ON THE STERILIZED PACKAGE WAS FOUND AND THIS AFFECTED PRODUCT CAN THUS NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501367 ↗
• MalfunctionMay 18, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED ABOUT DUST-LIKE FM ADHERING TO THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431822 ↗
• InjuryDec 13, 2021Break; Break

  DURING PROCEDURE NEEDLE GOT STUCKED INSIDE AND TOPMOST PART OF THE NEEDLE GOT BROKEN AND STUCKED INSIDE ONLY. HOW WAS ITEM PIECE RETRIEVED FROM PATIENT/PROCEDURE? IT WAS STILL INSIDE(BROKEN PART) OF THE PATIENT. WHAT WAS THE IMPACT TO THE PATIENT? WAS THE PATIENT INJURED? YES, PATIENT IS STILL INJURED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12984001 ↗
• MalfunctionSep 20, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS A REPORT ABOUT MISSING LEGALLY REQUIRED LABEL ON PACKAGE. IN RESPONSE TO THE OCCURRENCE REPORTED IN (B)(4), THE DISTRIBUTOR CHECKED THE PRODUCTS IN THE SHELF CARTON IN STOCK AND FOUND THAT THERE WAS NO LEGALLY REQUIRED LABEL ON THE PACKAGE OF ALL THE REMAINING EIGHT PRODUCTS. THE LEGALLY REQUIRED LABEL HAS BEEN AFFIXED TO THE SHELF CARTON. BDJ IS LEGALLY REQUIRED AS AN MAH TO AFFIX THE LABEL NOT ON THE PACKAGE BUT ON THE SHELF CARTON. PER FOLLOW-UP EMAIL: BDJ RECEIVED 8 UNOPENED PRODUCTS AND CONFIRMED THAT THE JAPANESE LABELS WERE NOT AFFIXED TO THE INDIVIDUAL PACKAGE. PLEASE REFER TO ATTACHED PHOTO. THE ACTUAL SAMPLE WON'T BE SENT BECAUSE IT IS A DEFECT DUE TO DOMESTIC WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500748 ↗
• MalfunctionSep 20, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS A REPORT ABOUT MISSING LEGALLY REQUIRED LABEL ON PACKAGE. THE CUSTOMER REPORTED THAT THERE WAS NO LEGALLY REQUIRED LABEL ON ONE PACKAGE, WHICH WAS DELIVERED FROM THE PRODUCTS BEING IN STOCK AT THE DISTRIBUTION¿S SIDE. THE LEGALLY REQUIRED LABEL HAS BEEN AFFIXED TO THE SHELF CARTON. BDJ IS LEGALLY REQUIRED AS AN MAH TO AFFIX THE LABEL NOT ON THE PACKAGE BUT ON THE SHELF CARTON. PER EMAIL, THE CUSTOMER REPORTED A LABEL USUALLY ADHERED TO INDIVIDUAL PACKAGE IS MISSING. TOUGH THE LABEL IS NOT LEGALLY REQUIRED AND LEGALLY REQUIRED LABEL NEEDS TO BE ADHERED TO SHELF CARTON. THE CUSTOMER REPORTED THE LABEL WAS ADHERED TO SHELF CARTON CORRECTLY. THEREFORE THE ISSUE IS ABOUT A LABEL ADHERED TO INDIVIDUAL PACKAGE IN JAPAN WAS MISSING. ON 10/14/2021 PER EMAIL : BDJ RECEIVED 1 UNOPENED PRODUCT AND CONFIRMED THAT THE JAPANESE LABEL IS NOT AFFIXED TO THE INDIVIDUAL PACKAGE. PLEASE REFER TO ATTACHED PHOTO. THE ACTUAL SAMPLE WON'T BE SENT BECAUSE IT IS A DEFECT DUE TO DOMESTIC WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500510 ↗
• InjurySep 16, 2021Break; Break

  IT WAS REPORTED THAT WHEN NEEDLE WAS REMOVED FROM PATIENT, IT WAS BROKEN IN THE MIDDLE AND SURGEON HAD TO REMOVE IT. THERE IS A NEW CASE REPORTED FROM FACILITY REPRESENTATIVE THAT THE DEVICE WAS BROKEN APART AT THE MIDDLE. PLEASE FIND THE INFORMATION BELOW FOR YOUR REFERENCE: WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? OBTAINING BONE MARROW BIOPSY FROM PATIENT'S PELVIS. DID ANY PART THE INSTRUMENT FALL INTO THE PATIENT¿S BODY, AND IF SO HOW WAS IT RETRIEVED? YES, THE CANNULA WAS FOUND BROKEN AT THE MIDDLE AND ABOUT 5CM OF IT WAS LEFT IN THE PATIENT'S BODY WHEN THE DR RETRIEVED THE CANNULA FROM THE PATIENT. AN SURGERY WAS PERFORMED NEXT DAY TO RETRIEVE THE BROKEN PART OF CANNULA FROM PATIENT SUCCESSFULLY. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT¿S BODY, SUCH AS AN X-RAY? NO. WHAT WAS THE PATIENT¿S OUTCOME? THE PATIENT STAYED IN THE WARD AFTER THE SURGERY TO RETRIEVE THE BROKEN CANNULA. PATIENT¿S CONDITION WAS STABLE. WAS THE PROCEDURE COMPLETED AS PLANNED? NO, THE DR STOPPED THE BONE MARROW BIOPSY PROCEDURE IMMEDIATELY AFTER NOTICING THE CANNULA WAS BROKEN. DO YOU HAVE PHOTOS OF THE REPORTED ISSUE ON THE INSTRUMENT? YES. PLEASE SEE

  Patient problems: Foreign Body In Patient

  MAUDE report 12481521 ↗
• MalfunctionJul 29, 2021Contamination; Contamination

  IT WAS REPORTED THAT INS QUALITY CONTROL DEPARTMENT FOUND A DEFECT AT THE TIP OF THE NEEDLE. (B)(6) 2021 08:22 PM (GMT-3:00) ADDED BY (B)(6) (PID-(B)(6)): NON-CONFORMITIES MENTIONED IN FILE ((B)(4)): PRESENCE OF UNEVEN EDGES/BURR ON THE CANNULA BEVEL. NON-UNIFORM EDGE IN STYLET. PRESENCE OF FOREIGN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249994 ↗
• InjuryApr 29, 2021Material Fragmentation; Material Fragmentation

  AN OSTEOMEDULLARY BIOPSY WAS PERFORMED ON (B)(6) 2021 AT 1PM IN AN INTENSIVE CARE PATIENT. WHEN THE TROCAR WAS MOBILIZED TO BREAK THE BIOPSY CORE, 2-3 CM OF TROCAR BROKE IN THE RIGHT POSTERIOR ILIAC SPINE. IMPOSSIBLE TO RECOVER THE MATERIAL. AFTER GETTING AN ADVICE, LEAVE THE MATERIAL IN PLACE. CONSEQUENCES: NOTED 3 WHICH CORRESPONDS TO WITH TRANSIENT DAMAGE (PHYSICAL OR MENTAL) TO THE PATIENT (REGRESSED BEFORE DISCHARGE AND WITHOUT THE INITIALLY PLANNED HOSPITALIZATION BEING PROLONGED BY MORE THAN 48 HOURS). CLINICAL CONSEQUENCES OBSERVED : IMPOSSIBLE TO RECOVER THE MATERIAL. CONSERVATIVE MEASURES AND ACTIONS TAKEN: AFTER ORTHO ADVICE, LEAVE THE MATERIAL IN PLACE. UNFORTUNATELY, THE MATERIAL COULD NOT BE REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11748246 ↗
• InjuryJan 4, 2021Break; Break

  IT WAS REPORTED VIA EMAIL: THAT A SMALL PORTION HAD FRACTURED IN THE VERTEBRAL BODY OF SI AND COULD NOT BE RETRIEVED. IT WAS REPORTED VIA EMAIL: A JAMSHIDI BONE MARROW BIOSPY /ASPIRATION NEEDLE WAS THEN UTILIZED AT THE LEFT SI PEDICLE VERTEBRAL BODY. THE PATIENT HAD VERY HARD BONE. IN TRYING TO REPOSITION THE JAMSHIDI INSTRUMENT, A SMALL PORTION HAD FRACTURED IN THE VERTEBRAL BODY OF SI AND COULD NOT BE RETRIEVED AND WAS LEFT IN THE VERTEBRAL BODY ON THE LEFT SIDE AT SI. THE BROKEN PIECE MEASURED ROUGHLY 2.5 CM. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: 14-SI NON INVASIVE PERCUTANEOUS PEDICLE SCREW INSTRUMENTED FUSION UTILIZING SPINEOLOGY PALISADE. L4-S1 ARTHRODESIS. L5 LAMINECTOMY.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 11114653 ↗