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TEMNO Evolution® 10884450443405Recalls & reported problems

Merit Medical Systems, Inc. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450443405), received between Nov 18, 2020 and May 4, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Output Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Output Problem1

Patient problems

  • Foreign Body In Patient1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 4, 2022Output Problem

    AN ELDERLY MALE IN THE CT SCAN DIAGNOSTIC IMAGING FOR PERCUTANEOUS LYMPH NODE BIOPSY. NO PATIENT INVOLVEMENT AS DEVICE WAS NOT INTRODUCED INTO PATIENT. DEVICE-RELATED ONLY, THIS PATIENT WAS NOT AFFECTED AS THE DEVICE WAS TESTED FIRST TO BE SURE THE LID/CAP OF THE INTRODUCER WOULD BE ABLE TO BE REMOVED FROM THE INTRODUCER AS RECENTLY THERE HAVE "BEEN A FEW" INSTANCES WHEREBY THE INTRODUCER IS DEPLOYED, AND WHEN READY TO ADD THE BIOPSY NEEDLE INTO THE INTRODUCER THE CAP WOULD NOT RELEASE AND THEN THE PROCEDURE WOULD HAVE TO BE REDONE (FIRST INTRODUCER WITHDRAWN, ANOTHER KIT OPENED AND THEN THE NEW INTRODUCER UTILIZED). OUR WORK AROUND/TEMPORARY PROCESS IS TO BE SURE THE LID IS NOT ADHERED TO THE INTRODUCER. IN THIS PARTICULAR CASE, NO DELAY IN PROCESS BUT A SECOND BIOPSY DEVICE WAS REQUIRED AND IN THE PAST EACH CASE APPARENTLY UTILIZED MORE THAN ONE DUE TO THIS NOW-REVEALED ISSUE. WE DO NOT HAVE AN ACCURATE COUNT OF PREVIOUS ISSUES BUT MOVING FORWARD THE TEAM WILL NOT ONLY MAKE NOTE BUT ALSO SECURE THE DEVICE INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14280116 ↗
  • InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE ACCOUNT ALLEGES THAT DURING A CT BONE BIOPSY THE NEEDLE BROKE APART WITHIN THE PATIENT IN THREE SEPARATE PIECES. PART OF THE NEEDLE IS STILL LODGED WITHIN THE PATIENTS BONE. [IFU STATES NOT INTENDED FOR USE IN BONE].

    Patient problems: Foreign Body In Patient

    MAUDE report 10863885 ↗

Other Biopsy needle devices

All Biopsy needle devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.