Atalante X ATA-002-EN USRecalls & reported problems
Wandercraft · The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Apr 3, 2025Class IIOpen, Classified
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Z-1739-2025 · Root cause: Use error · Recall details · FDA record ↗
Other Powered Exoskeleton devices
- ReWalk(TM) Personal 6.0 50-20-0004Lifeward Ltd · Powered Exoskeleton6 reports
- KEEOGO - CLINICIAN KIT 5062601B-Temia Inc · Powered Exoskeleton2 reports
- Indego Therapy 501-110-001Ekso Bionics, Inc. · Powered Exoskeleton2 reports
- ReWalk 7 Personal ExoskeletonLifeward Ltd · Powered Exoskeleton2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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