Teleflex (NYSE:TFX) subsidiary Arrow initiated a voluntary field safety corrective action for some intra-aortic balloon pump devices.
According to a safety notice issued in Europe, the devices have a potential issue around short battery run times. The devices can be powered by either an AC power source or battery power. As of Oct. 11, 2022, Teleflex received no reports of patient injuries or deaths related to the issue.
Affected devices include the Arrow AutoCAT 2 and Arrow AC3 Optimus pumps.
The affected pumps have an expected duration after a full charge of 90 minutes. However, some users reported short battery run times that included loss of power during use.
Additionally, the device design includes alarms. Those alert users of 20, 10 and 5 minutes of battery life remaining. In the past two years, Teleflex received one complaint of the unit shutting off without the alarms going off. It received 13 complaints reporting missing alarms where users reported the time remaining as inaccurate based on how quickly the battery depleted.
Immediate health consequences of battery failure include the cessation of intra-aortic balloon counter-pulsation. This could create a potentially life-threatening reduction in cardiac output. If left untreated, it could result in death.
Users should ensure they plug their pump into an AC outlet whenever possible during use. When not in use, users should keep batteries at full charge. Additionally, ensuring a fully charged and readily available backup pump remains on hand could mitigate the issues.
Teleflex recommends that qualified service personnel perform a battery test at least every 12 months. If a user identifies an issue with the battery load, they should immediately quarantine the device and contact Teleflex.
The news of the safety notice in Europe comes two years after Teleflex had a Class I level recall in the U.S. involving Arrow AutoCAT 2 and AC3 Optimus intra-aortic balloon pumps. The recall involved a possible breakdown of motor connector wires.