FDA Medical Device Recalls (openFDA)
Thoratec Corp.: Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
- Recall number
- Z-0308-2022
- Recalling firm
- Thoratec Corp.
- Product
- Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
- Status
- Open, Classified
- Initiated
- 2021-10-22
- Posted
- not on file
- Terminated
- not on file
- 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 a loaner System Monitor II at no charge until a corrective action is provided to your facility. If your facility has not previously used a System Monitor II, the recalling firm will provide training and implementation support to your facility. A firm representative will work with you to schedule a time that is convenient for you and your staff. If you have any questions about this communication or the recommendations, please contact your local representative or Technical Support at 1-800-456-1477 (U.S.). Please share this notice with all those within your organization who might operate the affected device. We ask that you maintain a record of this notice to ensure effectiveness of the communication. Please complete and return the response form.
- 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, 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.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DSQ
- Firm FEI
- 2916596
- Firm city
- Pleasanton
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28