FDA Device recall Z-1570-2025
HeartMate Mobile Power Unit: REF: 107754, NA
- FDA Device
- Class I
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class I recall of HeartMate Mobile Power Unit: REF: 107754, NA by Thoratec, citing left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1570-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-03-13 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Thoratec |
| Distribution | US |
Product
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Reason
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
Identifiers
| code_info | UDI-DI: 05415067038234. MPUs distributed between April 2024 and February 2025. Serial Numbers: 20226263, 20226264, 2022…UDI-DI: 05415067038234. MPUs distributed between April 2024 and February 2025. Serial Numbers: 20226263, 20226264, 20226265, 20226266, 20226267, 20226268, 20226269, 20226270, 20226271, 20226272, 20226273, 20226274, 20226275, 20226276, 20226277, 20226278, 20226279, 20226280, 20226281, 20226282, 20226283, 20226284, 20226285, 20226286, 20226287, 20226288, 20226289, 20226290, 20226291, 20226292, 20240622, 20240623, 20240624, 20240625, 20240626, 20240627, 20240628, 20240629, 20240630, 20240631, 20240632, 20240633, 20240634, 20240635, 20240636, 20240637, 20240638, 20240639, 20240640, 20240641, 20240642, 20240643, 20240644, 20240645, 20240646, 20240647, 20240648, 20240649, 20240650, 20240651, 20240652, 20240653, 20240654, 20240655, 20240656, 20240657, 20240658, 20240659, 20240660, 20240661, 20240662, 20240663, 20240664, 20240665, 20240666, 20240667, 20240668, 20240669, 20240670, 20240671, 20240672, 20240673, 20240674, 20240675, 20240676, 20240677, 20240678, 20240679, 20240680, 20240681, 20240 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1570-2025%22
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