WANDERCRAFT SAS recalls Atalante X

Potential for exoskeleton to lose lateral balance and cause patient to fall.

Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.

An URGENT SAFETY NOTICE dated 4/3/25 was mailed to consignees. The letter notifies consignees that WANDERCRAFT will be reinforcing their training program for the Atalante X and providing additional instructions by 5/1/25. Until the additional instructions can be provided, users are being instructed to only have certified Atalante X operators maintain the stability of the exoskeleton at all times by keeping at least one hand on the handles throughout the session. Consignees are to share the recall notification with users at their facility and retained for awareness.

• FDA enforcement recordOfficial FDA database entry for Z-1739-2025
• FDA 510(k) clearance · K221859The device's official FDA premarket clearance record
• FDA device classification · PHLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 890.3480The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find WANDERCRAFT SASSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.