MEDEASY ML18080-K0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08054301667419), received between Mar 26, 2021 and Jun 17, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2021Detachment of Device or Device Component

  PATIENT WITH HISTORY OF STAGE IV FOLLICULAR LYMPHOMA WAS ADMITTED FOR AN ULTRASOUND BIOPSY OF LYMPH NODE. WHILE PHYSICIAN WAS DOING THE PROCEDURE, THE MEDAX SRL UNIPERSONALE MEDEASY SOFT TISSUE SEMI-AUTOMATIC BIOPSY NEEDLE CAME UNGLUED. ANOTHER BIOPSY NEEDLE WAS USED AND IT CAME UNGLUED AS WELL. BOTH BIOPSY NEEDLES HAD THE SAME LOT #. A THIRD BIOPSY NEEDLE WAS USED WITHOUT PROBLEMS. NO KNOWN HARM DONE TO PATIENT. THIS IS THE 6TH REPORT OF THIS BIOPSY NEEDLE COMING UNGLUED. PURCHASING DEPARTMENT IS AWARE AND HAS ALL LOT NUMBERS: 21-121, 21-75, 21-67, 21-64

  Patient problems: Insufficient Information

  MAUDE report 12016283 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component

  PATIENT WITH HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND INCREASING SHORTNESS OF BREATH WAS ADMITTED FOR A SOFT-TISSUE RIGHT BREAST BIOPSY. PRIOR TO INSERTING NEEDLE INTO PATIENT, THE MEDAX SRL UNIPERSONALE MEDEASY SOFT TISSUE SEMI-AUTOMATIC BIOPSY NEEDLE 18G X 80 MM (LOT # 06186-20, REF # ML18080-KO) CAME UNGLUED. THE DEFECTIVE NEEDLE WAS NEVER PLACED INTO THE PATIENT. ANOTHER OF THE SAME TYPE AND LOT # OF THAT NEEDLE WAS OPENED AND USED. THIS IS NOT THE FIRST EVENT FOR THIS PRODUCT, REPORTED SAME INCIDENT WITH THIS TYPE OF DEVICE IN THE RECENT PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964806 ↗
• MalfunctionApr 7, 2021Material Separation

  UPPER MIDDLE-AGED MALE WITH HISTORY OF LYMPHADENOPATHY. WHILE HAVING A LEFT NECK LYMPH NODE BIOPSY WITH ULTRASOUND, THE STYLET CAME UNGLUED. DEVICE REMOVED AND ANOTHER MEDAX USED, RE-INSERTED INTO THE SAME SITE. NO KNOWN HARM TO PATIENT. NOTE THIS IS THE 4TH DEVICE REPORTED WITH THIS LOT NUMBER. PLEASE REFER TO 3600840000-2021-8041 AND 8042.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628262 ↗
• MalfunctionMar 26, 2021Detachment of Device or Device Component

  MIDDLE AGED FEMALE WITH THYROID NODULE. PERFORMING A RADIO-LOGICAL ULTRASOUND GUIDED CORE BIOPSY. THE BIOPSY NEEDLE WORKING GUIDE CAME APART. 2 SETS USED WITH THE SAME LOT # AND CAME APART IN THE SAME FASHION. A THIRD DEVICE WAS USED WITHOUT PROBLEMS. NO KNOWN HARM TO PATIENT. PLEASE MAKE NOTE THAT 2 DEVICES THAT MALFUNCTIONED WITH THE SAME LOT NUMBER. THERE WAS ANOTHER INCIDENT THAT DID THE SAME THING THE WEEK BEFORE, BUT THE DEVICE WAS NOT SAVED.

  Patient problems: Insufficient Information

  MAUDE report 11574114 ↗
• MalfunctionMar 26, 2021Loose or Intermittent Connection

  AN UPPER-MIDDLE AGED FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE, FACTOR V LEYDEN MUTATION, AND HYPERTENSION, PRESENTED TO EMERGENCY DEPT WITH ABDOMINAL PAIN. HAVING AN ULTRASOUND BIOPSY OF ABDOMINAL CORE. AFTER INSERTING INTO THE PATIENT, THE BIOPSY NEEDLE WAS NOT FIRMLY ATTACHED TO THE PLASTIC BASE. DEVICE REMOVED AND A REPLACEMENT WAS USED. NO KNOWN HARM TO THE PATIENT. DEVICE WAS NOT SAVED.

  Patient problems: Insufficient Information

  MAUDE report 11574113 ↗