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Venner™ PneuX P.Y.™ ETT MRI

VENNER MEDICAL (SINGAPORE) PTE. LTD. · Model 901160 · UDI-DI 08885009190752

BTR

510(k) clearances

19,094

Adverse events (256 deaths)

226

Recalls

132

Facilities

Description

The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended periods (not more than 30 days) of intensive or critical care, and for evacuation or drainage of secretion from the subglottic space. It is also safety in an MRI environment (indicated MRI) and compatible with Tracheal intubation during routine anaesthesia.

Recalls

Date	Firm	Reason
2025-02-13	Smiths Medical ASD, Inc.	Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulm
2024-02-26	MEDLINE INDUSTRIES, LP - Northfield	Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inf
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

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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.