Recall Z-0308-2022 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp.
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
| Date | Oct 22, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | On 10/22/21, correction notices were provided via site visit, or email. Until the resolution is provided, the recalling firm is requesting that your facility retain or obtain the System Monitor II (Model Numbers 1286 and L1286) and ensure it is readily available for use in the event that the LVAS communication system is unable to function properly. The recalling firm is extending the support and servicing of System Monitors II until this issue is resolved and the resolution is fully implemented in the field. If your facility does not have a System Monitor II, the recalling firm will provide |
| Quantity | 988 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, IL, PA, AR, GA, WI, AZ, TN, TX, MA, NE, CA, VA, NC, OH, MI, DC, IN, NJ, CT, OK, MD, NY, ME, IA, SC, KY, LA, OR, NM, WA, SD, MO, NV, HI, AL, MS, UT, KS and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.