The FDA has posted 11 enforcement recalls of ventricular (assist) bypass devices since 2025, including 3 Class I (most serious) recalls. Most recent report: Jun 24, 2026.
Due to 11 volt Backup Battery failures.
Due to 11 volt Backup Battery failures.
Due to 11 volt Backup Battery failures.
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
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 Wren…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Ventricular (Assist) Bypass”). Informational only — verify against the FDA before acting.