TEMNO ACT1811Recalls & reported problems
Carefusion 2200, Inc · TEMNO NEEDLE BIOPSY 18GX11CM ADJUSTABLE COAXIAL · Class 1
- 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 10885403088551), received between Apr 7, 2021 and Apr 7, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2021Fracture; Fracture
THE ACCOUNT ALLEGES THAT DURING A BIOPSY PROCEDURE, UPON ACTIVATING THE DEVICE THE DEVICE SPLIT INTO TWO PIECES. NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 11631528 ↗
Other GUIDE, NEEDLE, SURGICAL devices
- GHIATAS® 47920Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL20 reports
- DuaLok™ LW0107Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL11 reports
- GHIATAS® 47720Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL7 reports
- GHIATAS® 477201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL7 reports
- PERL Localization Device R2020Focal Therapeutics, Inc. · Guide, Needle, Surgical7 reports
- GHIATAS® 475201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL6 reports
- GHIATAS® 479201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
- DuaLok™ LW0077Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.