Teleflex warns on some intra-aortic balloon pumps - Mass Device

Teleflex (NYSE:TFX) subsidiary Arrow initiated a voluntary tract information corrective enactment for immoderate intra-aortic balloon pump devices.

According to a information notice issued successful Europe, the devices person a imaginable contented astir abbreviated artillery tally times. The devices tin beryllium powered by either an AC powerfulness root oregon artillery power. As of Oct. 11, 2022, Teleflex received nary reports of diligent injuries oregon deaths related to the issue.

Affected devices see the Arrow AutoCAT 2 and Arrow AC3 Optimus pumps.

The affected pumps person an expected duration aft a afloat complaint of 90 minutes. However, immoderate users reported abbreviated artillery tally times that included nonaccomplishment of powerfulness during use.

Additionally, the instrumentality plan includes alarms. Those alert users of 20, 10 and 5 minutes of artillery beingness remaining. In the past 2 years, Teleflex received 1 ailment of the portion shutting disconnected without the alarms going off. It received 13 complaints reporting missing alarms wherever users reported the clip remaining arsenic inaccurate based connected however rapidly the artillery depleted.

Immediate wellness consequences of artillery nonaccomplishment see the cessation of intra-aortic balloon counter-pulsation. This could make a perchance life-threatening simplification successful cardiac output. If near untreated, it could effect successful death.

Users should guarantee they plug their pump into an AC outlet whenever imaginable during use. When not successful use, users should support batteries astatine afloat charge. Additionally, ensuring a afloat charged and readily disposable backup pump remains connected manus could mitigate the issues.

Teleflex recommends that qualified work unit execute a artillery trial astatine slightest each 12 months. If a idiosyncratic identifies an contented with the artillery load, they should instantly quarantine the instrumentality and interaction Teleflex.