Jamshidi TJM4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403044588), received between Nov 2, 2021 and Oct 15, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Contamination” (4 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 23, 2021Open, Classified

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

   Z-2247-2021 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Contamination; Contamination

  IT WAS REPORTED THAT ON 22-SEP-2025 EIGHT JAMSHIDI NEEDLES WERE IDENTIFIED CONTAINING SOME SORT OF FOREIGN PARTICLES. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290436 ↗
• MalfunctionFeb 5, 2025Contamination; Contamination

  CUSTOMER RETURNS 10 UN OF MATERIAL TJM4011 - 0001560431 DUE TO QUALITY PROBLEMS IN THE PRODUCT (PRESENCE OF FOREIGN BODY IN 1 UN). (PRESENCE OF FOREIGN BODY IN 1 ONE). ATTACHED EVIDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312736 ↗
• MalfunctionJan 30, 2025Contamination; Contamination

  1 EV WITH 10 PCS OF LOT: 0001560431 (1 PC WITH PRESENCE OF FOREIGN BODY; SMALL PLASTIC PARTICLES) IS REJECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274328 ↗
• MalfunctionMar 25, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED NEEDLE BENT. VERBATIM: NEEDLE TIP CRUMBLING AND LOSING SAMPLES. PER EMAIL: WE HAVE RECENTLY HAD TO CHANGE BONE MARROW BIOPSY NEEDLES FROM THE ORIGINAL JAMSHIDI TO THE T-HANDLE JAMSHIDI AND HAVE ENCOUNTERED SOME ISSUES WITH THE TIPS CRUMPLING/ LOOSING SAMPLES. WHILE THIS IS CERTAINLY CONCERNING, THE PURPOSE OF THIS EMAIL TODAY IS TO INQUIRE IF THERE ARE TECHNIQUE CHANGES AND ALTERNATIONS NEEDED BETWEEN THE TWO NEEDLES. IT SEEMS THAT THE T-HANDLE JAMSHIDI REQUIRE LESS FORCE, BUT ARE THERE OTHER APPROACHES THAT CAN REDUCE THIS TIP DEFORMATION? 10MAR2022: CUSTOMER SAID 4 OCCURRENCES HAPPENED ON (B)(6), EMAILED THE INCIDENTS ON MARCH 4 TO BD CUSTOMER SERVICE, CLARIFIED THAT NEEDLE BENT NOT CRUMBLED. IS WAITING ON REPORTS CONCERNING PATIENT IMPACT TO ANSWER SPECIFIC QUESTIONS, SAID THAT IT WILL MORE THAN LIKELY BE WITHIN THE WEEK. PER EMAIL 10MAR2022 : JUST TO CLARIFY, IS THIS EMAIL IN RESPONSE TO A PRODUCT COMPLAINT FILED TOWARDS THE END OF (B)(6)? OR IS THIS EMAIL IN RESPONSE TO THE TECHNIQUE EMAIL SENT EARLIER THIS MONTH? WE HAVE HAD MULTIPLE QUALITY ISSUES WITH THESE T HANDLE JAMSHIDIS AND AM UNSURE WHICH INSTANCE YOU ARE REFERRING TO. AS FOR SOME GENERAL INFORMATION,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904678 ↗
• MalfunctionMar 4, 2022Contamination; Contamination

  WHERE DURING THE CONTROL A BLUE PLASTIC DEBRIS WAS NOTICED. HE OBSERVED THE PRESENCE OF "BLUE" COLORED PARTICLES (INSIDE THE INDIVIDUAL PACKAGING) WHICH WOULD APPEAR TO BE "DEBRIS" OF BLUE PLASTIC FROM THE DEVICE. THE MANUFACTURER IS REQUIRED TO JUSTIFY THE PRESENCE AND HARMLESSNESS OF THESE "DEBRIS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13670643 ↗
• InjuryNov 2, 2021Break; Break

  AFTER THE BIOPSY, THE NEEDLE WAS BROKEN IN THE PATIENT'S BODY WHILE REMOVING THE NEEDLE - WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? BONE MARROW BIOPSY ASPIRATION. - HOW WAS ITEM PIECE RETRIEVED FROM PATIENT/PROCEDURE? THE SURGEON CONDUCTED ANOTHER SURGERY TO RETRIEVE THE BROKEN PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12740192 ↗