Recall Z-0308-2022— Thoratec Corp.
Class II · Ongoing
Class II FDA medical device recall by Thoratec Corp., initiated 2021-10-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU). Reason: 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..
- Recalling firm
- Thoratec Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-22
- Firm location
- Pleasanton, CA, United States
Product description
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.