TEMNO® 10884450443177Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450443177), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Align1
- Mechanical Problem1
- Mechanics Altered1
Patient problems
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Mechanical Problem; Failure to Align; Mechanics Altered; Mechanical Problem; Failure to Align; Mechanics Altered
THE ACCOUNT ALLEGES THAT THE FIT BETWEEN THE INNER AND OUTER NEEDLES WAS INSUFFICIENT, AIR WAS ABLE TO ENTER THE PLEURAL CAVITY. THIS RESULTED IN THE PATIENT DEVELOPING A PNEUMOTHORAX.
Patient problems: Pneumothorax
MAUDE report 22909968 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.