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Cuffix

BIOVO TECHNOLOGIES LTD · Model 01 · UDI-DI 07290017345017

BSK Prescription

510(k) clearances

423

Adverse events (9 deaths)

Recalls

Facilities

Description

The Cuffix is intended to measure and regulate, through passive control, intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.

Recalls

Date	Firm	Reason
2026-05-22	Hamilton Medical AG	Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by
2023-08-22	Covidien	Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several
2017-06-20	Hamilton Medical, Inc.	Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
2013-08-27	H & H Associates	Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.

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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.