Recall Z-0842-2024 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp.
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartM
| Date | Feb 2, 2024 (initiated Jan 3, 2024) |
| Status | Open, Classified |
| Reason | Due to software and controller systems that results in unexpected pump start or pump stop. |
| Root cause | Software design |
| Action | On 01/03/2024, the firm sent an Urgent Medical Device Correction Letter via hand delivery to U.S. customers informing them that Abbott has received complaints for the HeartMate Touch Communication System application (App) version 1.0.32 due to unintentional start/stop of the HeartMate 3 Left Ventricle Assist Device (LVAD). -Customer should be able to identify the software version of the HeartMate Touch App by tapping "Menu" and "About" on the left-hand panel on the HeartMate Touch screen. -When the "STOP PUMP" sequence needs to be performed, follow the instructions in the Instructions For |
| Quantity | 1,560 systems as of 12/8/2023 |
| Distribution | Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.