Z-0308-2022Class II

Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

Name: Z-0308-2022 Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Creator: Thoratec Corp.
Published: 2021-10-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-10-22 / Open, Classified / root cause: software

FDA source

Thoratec Corp. began a recall of Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU) on 2021-10-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0308-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-22
Posted: 2021-11-26
Recalling firm: Abbott Medical
Product: Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0308-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0308-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-08	2021-11-26

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)