Adjustable Coaxial TEMNO™ A.C.T. 10884450444037Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450444037), received between Dec 9, 2025 and Dec 9, 2025 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, A MERIT EMPLOYEE CONDUCTED A PMCF REVIEW FOR THE MERIT MEDICAL TEMNO ACT PRODUCT FAMILY. CUSTOMER REPORTED THAT FOLLOWING A LUNG BIOPSY PERFORMED WITH AN ADJUSTABLE COAXIAL TEMNO¿ (ACT) BIOPSY NEEDLE (18G × 15 CM) AND 17G COAXIAL INTRODUCER, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING MEDICAL MANAGEMENT. NO DEVICE MALFUNCTION WAS REPORTED.
Patient problems: Pneumothorax
MAUDE report 23758613 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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