Home › DISA MEDINOTEC (PTY) LTD › Trachealator

Trachealator

DISA MEDINOTEC (PTY) LTD · Model TRD1 · UDI-DI 06009698450009

KTI Prescription

510(k) clearances

977

Adverse events (8 deaths)

Recalls

Facilities

Description

The Trachealator Non-occlusive Airway Dilation Balloon is comprised of a single lumen, over-the wire, catheter with a clustered balloon system near the distal tip. The balloon cluster, when inflated, features a inter balloon space to avoid airway occlusion during deployment. The inflated balloon cluster generates a strong outward force for dilation of airway strictures. A guidewire is provided to facilitate the advancement of the Trachealator Non-occlusive Airway Dilation Balloon to the desired location.

Recalls

Date	Firm	Reason
2025-08-06	Olympus Corporation of the Americas	Potential for undetected, deformed a-traumatic tips.
2025-04-04	Integra LifeSciences Corp. (NeuroSciences)	Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
2023-05-16	Bryan Medical Inc	Devices were mislabeled.
2018-10-17	Richard Wolf GmbH	There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen.
2013-01-11	Acclarent, Inc.	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
2013-01-11	Acclarent, Inc.	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
2013-01-11	Acclarent, Inc.	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
2013-01-11	Acclarent, Inc.	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
2013-01-11	Acclarent, Inc.	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
2013-01-11	Acclarent, Inc.	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.