TEMNORecalls & reported problems across all models
Merit Medical Systems, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one TEMNO model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 6 models of TEMNO by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2021 and Sep 24, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
TEMNO recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2022Class IIOpen, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1600-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported TEMNO problems
Device problems
- Difficult to Advance1
- Difficult to Remove1
- Failure to Align1
- Fracture1
- Insufficient Device Problem Information1
- Material Separation1
- Mechanical Problem1
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Pneumothorax2
TEMNO models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TEMNO® 10884450444464Biopsy needle1 recall0 reports
- TEMNO® 10884450443177GUIDE, NEEDLE, SURGICAL1 report
- TEMNO® 10884450443191GUIDE, NEEDLE, SURGICAL1 report
- TEMNO® 10884450444112Biopsy needle1 report
- TEMNO® 10884450444174Biopsy needle1 report
- TEMNO® 10884450444181Biopsy needle1 report
Recent TEMNO adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Insufficient Device Problem Information
Patient problems: Pneumothorax
MAUDE report 50892023 ↗MalfunctionJan 20, 2026Difficult to Advance
THE ACCOUNT ALLEGES THAT THE NEEDLE WILL NOT PASS THROUGH TO COAXIAL. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24119214 ↗MalfunctionDec 10, 2025Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking
CUSTOMER ALLEGED WHEN REMOVING THE INNER NEEDLE OF THE INTRODUCER, IT FELT STIFFER THAN USUAL BUT IT COULD BE REMOVED. WHEN ATTEMPTING TO INSERT THE BIOPSY NEEDLE INTO THE COAXIAL INTRODUCER, RESISTANCE WAS ENCOUNTERED APPROXIMATELY 2-3 CM AFTER THE NEEDLE TIP ENTERED INTO THE COAXIAL INTRODUCER. AFTER REPLACING BOTH THE INTRODUCER AND THE BIOPSY NEEDLE WITH NEW ONES, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772085 ↗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 ↗InjuryFeb 3, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS SUCCESSFULLY REMOVED VIS VASCULAR SNARE DEVICE. NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11274002 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page