FDA recall Z-0308-2022

Thoratec Corp. · Class II · device

Product

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.

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, DENMARK, FRANCE, GERMANY, IRELAND, ISRAEL, ITALY, KUWAIT, LITHUANIA, NETHERLANDS, NEW ZEALAND, POLAND, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, UNITED KINGDOM.

Key facts

Status
Ongoing
Initiation date
2021-10-22
Report date
2021-12-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pleasanton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0308-2022