Jamshidi DIN1515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403087042), received between Jan 20, 2022 and May 13, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A BONE MARROW PROCEDURE WAS PERFORMED. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT PRESENTED WITH ARTHRALGIA, ODYNOPHAGIA, PRODUCTIVE COUGH, AND FEVER OF 38.2°C. THE PATIENT WAS DIAGNOSED WITH FEVER AND NEUTROPENIA (LOW WHITE BLOOD CELL COUNT), AND NEUROPATHIC PAIN RELATED TO THE USE OF VENCRISTINA (VENCRISTINE) CHEMOTHERAPY MEDICATION. THE PAIN WAS LOCATED IN THE LEFT LOWER EXTREMITY. FURTHER PHYSICAL EXAMINATION IDENTIFIED THE PAIN WAS ON MEDIAL PALPATION OF THE LEFT LEG. THE PATIENT BLOOD METRICS WERE TAKEN AND BASED ON THE RESULTS THE PATIENT WAS PRESCRIBED CEFEPIME TO TREAT THE FEVER AND NEUTROPENIA (LOW WHITE BLOOD CELL COUNT). IT WAS FURTHER REPORTED THAT AN INCREASE IN VOLUME AND REDNESS WAS OBSERVED, ACCOMPANIED BY A HIGH TEMPERATURE IN THE LEFT INNER THIGH; THEREFORE, INFECTIOUS CELLULITIS WAS DIAGNOSED AND CEPHALOTHIN WAS ALSO PRESCRIBED FOR TREATMENT WHICH WAS LATER SUSPENDED AND REPLACED WITH VANCOMYCIN DUE TO UNFAVORABLE TREATMENT EVOLUTION.

  Patient problems: Arthralgia; Cough; Dysphagia/ Odynophagia

  MAUDE report 22015452 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A BONE MARROW ASPIRATION PROCEDURE WAS PERFORMED. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT PRESENTED ERYTHEMA, PAIN, AND HEAT AT THE ASPIRATION PUNCTURE SITE. GIVEN THESE FINDINGS, TREATMENT WITH CEPHALOTHIN WAS INITIATED TO TREAT THE BACTERIAL INFECTION. IT WAS FURTHER REPORTED THAT ON (B)(6) 2025, THE LESION WAS POORLY EVOLVING, AND THE SIZE INCREASED TO APPROXIMATELY 4X3CM. IT WAS ALSO MENTIONED THAT GREATER ERYTHEMA, EDEMA, AND LOCALIZED INDURATION, BLACKISH COLORATION IN THE CENTER OF THE LESION, ACCOMPANIED BY AN INCREASED IN LOCAL TEMPERATURE, WITHOUT THE PRESENCE OF FLUID OR PUS (SEROPURULENT SECRETION) WAS OBSERVED. AN ULTRASOUND STUDY OF THE RIGHT ILIAC CREST AND GLUTEUS SHOWED INFLAMMATORY CHANGES IN THE PUNCTURE SITE, WITH NO EVIDENCE OF COLLECTIONS; THEREFORE, CEPHALOTHIN ANTIBIOTIC MEDICATION WAS SUSPENDED AFTER 10 DAYS OF USE AND THERAPY WITH VANCOMYCIN WAS STARTED TO CONTINUE BACTERIAL INFECTION TREATMENT. HOWEVER, A PURULENT ABSCESS (PUS) DEVELOPED WHICH WAS DRAINED AND CULTURED. ON (B)(6) 2025, THE TREATMENT WAS SUCCESSFUL WITH CLINICAL IMPROVEMENT OF THE WOUND, SO THE PATIENT WAS GIVING CEFEPIME FOR 10 DAYS AND 14 DAYS OF VAN

  Patient problems: Erythema; Local Reaction; Pain

  MAUDE report 22015451 ↗
• MalfunctionApr 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CIRCUMSTANCES OF OCCURRENCE/DESCRIPTION OF FACTS: WE DISCOVERED A SUSPICIOUS ELEMENT (CF. EYELASH OR SIMILAR) IN THE PACKAGING OF A BIOPSY DEVICE REFDIN1515X , LOT 0001505611 PER (B)(4).WE KEPT THE DEVICE. RESPONSE RECEIVED THE INCIDENT SEEMS CLEAR TO ME, HOWEVER. I DON'T KNOW WHAT MORE I CAN TELL YOU. THE CAREGIVER DETECTED BEFORE USING THE DEVICE THAT THERE WAS A SUSPICIOUS ELEMENT (AN EYELASH, OR EQUIVALENT...) IN THE PACKAGING. AS A RESULT, THE DEVICE WAS ISOLATED AND THEREFORE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19120480 ↗
• InjuryJan 20, 2022Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  THIS IS A REPORT ABOUT LEAKAGE WITH THE USE OF BONE MARROW NEEDLE (DIN1515X). THE CUSTOMER REPORTED AS FOLLOWS: AFTER VENIPUNCTURE, THE HCP CONNECTED THIS PRODUCT TO AN IV LINE AND STARTED INFUSION. THE HCP THEN SAW THE FLUID LEAKING FROM THE ROOT OF THE CANNULA. WHEN THE HCP USED ANOTHER NEW PRODUCT, THE SAME ISSUE OCCURRED. THEN, ANOTHER NEW PRODUCT WAS USED IN THE ABSENCE OF VENIPUNCTURE AS A TRIAL, AND THE SAME ISSUE RECURRED. LEAKED MEDICATION WAS SALINE. THE HPC USED THE ITEM TO THE PATIENT WHO IS CARDIOPULMONARY ARREST. WHEN SYRINGE IS CONNECTED, LEAKAGE BETWEEN LIGHT PURPLE AND BLUE HOUSING WAS FOUND. THEN THE HCP CHANGED TO PLACE CATHETER TO INITIATE INTRAVENOUS INFUSION INSTEAD OF INTRAOSSEOUS INFUSION. THE HCP HASN¿T PERFORMED ADDITIONAL PUNCTURE WITH USING DIX1515X. THE HCP STATED THAT THE PATIENT WAS CARDIOPULMONARY ARREST WHEN MEDICATION WAS INITIATED AND RESUSCITATION WAS NOT POSSIBLE. STRICTLY SPEAKING, IT CAN BE SAID THAT THE DELAY IN INFUSION DUE TO THIS DEFECT HAS A NON-ZERO EFFECT ON RESUSCITATION, BUT IT IS NOT CONSIDERED TO BE A DIRECT CAUSE. ACTUAL SAMPLE WAS ALREADY DISCARDED. THE HCP DEMONSTRATED WHAT THE HCP FOUND WITH USING THE ITEM FROM THE SAME BATCH AN

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306977 ↗