Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Reported: December 8, 2021 Initiated: October 22, 2021 #Z-0308-2022
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.
Details
- Recalling Firm
- Thoratec Corp.
- Units Affected
- 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, 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.
- Location
- Pleasanton, CA
Frequently Asked Questions
What product was recalled? ▼
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU). Recalled by Thoratec Corp.. Units affected: 988.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 8, 2021. Severity: Moderate. Recall number: Z-0308-2022.
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