ReWalk 7 Personal ExoskeletonRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860001744514), received between Aug 19, 2025 and Sep 28, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Insufficient Device Problem Information

  On (b)(6) 2026, during two ReWalk trial sessions, the patient underwent repeated unsuccessful sit-to-stand attempts, each followed by a controlled return to sitting.NO falls, uncontrolled movement, abnormal sound, or device malfunction were reported during the sessions. NO pain, bruising, skin abnormality, or other evidence of injury was reported during or immediately after the sessions. On (b)(6) 2026 - the patient reported bruising and swelling in the left leg. The Lifeward team advised patient to seek medical attention.On (b)(6) 2026 - the patient reported she was diagnosed with left tibia/fibula fracture requiring a cast for approximately 8 weeks. The exact location of the fracture was not reported. The incident is currently under investigation.

  Patient problems: Limb Fracture

  MAUDE report 50913496 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING DATA WAS REPORTED TO THE LIFEWARD CLINICAL TRAINING MANAGER BY A PHYSICAL THERAPIST AT THE USER'S TRAINING CLINIC: ON (B)(6) 2025: THE USER REPORTED A PINCHING SENSATION IN HER RIGHT HIP DURING USE OF THE DEVICE. LATER THAT SAME DAY, DURING A FOLLOW-UP SESSION, SHE REPORTED THAT THE PINCHING DID NOT RECUR. ON (B)(6) 2025: THE USER CANCELLED HER SESSION DUE TO SWELLING IN HER LEFT LEG. THE USER BELIEVES THIS MAY BE RELATED TO THE STENTS IN HER GROIN AND POSSIBLY THE CAUSE OF THE EARLIER PINCHING SENSATION. ON (B)(6) 2025: THE USER VISITED THE ER AND WAS DIAGNOSED WITH BLOOD CLOTS IN HER LEG. THE USER IS AWAITING CONSULTATION WITH HER PHYSICIAN TO DETERMINE THE NEXT STEPS IN TREATMENT. THE INCIDENT WAS RECORDED UNDER CUSTOMER COMPLAINT NUMBER: (B)(4).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22836808 ↗