medical Class II Updated 2021-12-08

Thoratec Corp. recalls Abbott HeartMate Touch Communication System, REF: HMT1100 (U

Recalled Product

Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)


Hazard / Issue

If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All serial numbers.
View official government recall

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