ReWalk(TM) Personal 6.0 50-20-0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00861803000303), received between Mar 30, 2018 and Dec 23, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K160987); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT REPORTED HIP PAIN WHILE WALKING DURING A TRAINING SESSION ON (B)(6) 2024. AS A PRECAUTION, THE SESSION WAS STOPPED. DUE TO THE MINIMAL NATURE OF THE PAIN, THE PATIENT PARTICIPATED IN ANOTHER TRAINING SESSION ON (B)(6) 2024. PRIOR TO THE SESSION, THE PATIENT PERFORMED STRETCHING EXERCISES. DURING THE SESSION, THE PATIENT EXPERIENCED DISCOMFORT WHILE STANDING AND INCREASED PAIN WHEN ATTEMPTING TO TAKE A FEW STEPS. CONSEQUENTLY, THE SESSION WAS STOPPED, AND THE PATIENT EXITED THE DEVICE. ON (B)(6) 2024, A LIFEWARD REPRESENTATIVE RECEIVED A MESSAGE FROM THE PATIENT INDICATING THAT HE HAD BEEN DIAGNOSED WITH A RIGHT FEMORAL NECK FRACTURE. THIS INCIDENT WAS DOCUMENTED UNDER CUSTOMER COMPLAINT NUMBER: (B)(4).

  Patient problems: Hip Fracture

  MAUDE report 21000651 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT HAD BEEN USING A REWALK DEVICE FOR SEVERAL YEARS. ON (B)(6) 2024, THE PATIENT USED A NEWLY DELIVERED REWALK DEVICE FOR THE FIRST TIME FOR APPROXIMATELY 30 MINUTES. THE SETTINGS ON THE NEW DEVICE WERE THE SAME AS HIS PREVIOUS DEVICE. NO ISSUES WERE REPORTED DURING THE FITTING PROCESS AND THERE WERE NO REPORTS OF DEVICE MALFUNCTION BEFORE OR DURING USE. ON OCTOBER 19, 2024, LIFEWARD REPRESENTATIVE RECEIVED A MESSAGE FROM THE PATIENT, REPORTING THAT SEVERAL DAYS AFTER HIS SESSION WITH THE NEW REWALK DEVICE ON (B)(6) 2024, HE NOTICED HIS RIGHT FOOT'S TOES TURNING BLUE. HE ATTEMPTED SELF-CARE AT HOME WITHOUT IMPROVEMENT, AND AFTER 12 DAYS, SOUGHT MEDICAL ATTENTION, LEADING TO HIS HOSPITALIZATION. SUBSEQUENTLY, THE PATIENT REPORTED UNDERGOING AN AMPUTATION OF THE LATERAL PART OF HIS FOREFOOT. THE INCIDENT WAS RECORDED UNDER CUSTOMER COMPLAINT NUMBER: (B)(4).

  Patient problems: Insufficient Information; Unspecified Vascular Problem

  MAUDE report 20682019 ↗
• InjurySep 22, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS USING THE REWALK DEVICE FOR A TOTAL OF 7 TRAINING SESSIONS DURING AND (B)(6) 2024. ON(B)(6) 2024, THE PATIENT REPORTED TO THE REWALK CLINICAL TRAINING MANAGER THAT SHE WAS DIAGNOSED WITH A FRACTURE AT THE LEFT KNEE. THE INCIDENT WAS RECORDED UNDER CUSTOMER COMPLAINT NUMBER: (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 20275819 ↗
• MalfunctionApr 13, 2021Fire; Battery Problem; Fire; Battery Problem

  THE CUSTOMER HAS INFORMED REWALK CLINICAL TRAINER THAT THE WAISTPACK OF THE DEVICE (WHERE THE LI-ION BATTERY PACKS ARE LOCATED) CAUGHT FIRE WHILE IT WAS BEING CHARGED FOR APPROXIMATELY 6 HOURS AT HIS HOUSE. THE CUSTOMER WAS NOT USING THE SYSTEM WHEN THE INCIDENT OCCURRED (THE DEVICE INCLUDES A SAFETY MEASURE THAT PREVENTS POWERING ON THE DEVICE WHILE IT IS BEING CHARGED). THERE WERE NO INJURIES AS A RESULT OF THE INCIDENT AND THERE WAS MINOR DAMAGE CAUSED TO THE FLOOR WHERE THE DEVICE WAS STORED. THE DEVICE WAS MAINLY DAMAGED IN THE WAISTPACK AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655212 ↗
• InjuryMar 30, 2018Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  HE INCIDENT MAY HAVE HAPPENED DURING TRAINING. THE FRACTURES ARE ABOVE THE POSITION OF THE FRONT KNEE BRACKET (FKB) AND BELOW THE KNEE. ALSO, THERE IS A PRESSURE POINT IN THE HEIGHT OF THE SACROILIAC ON THE BACK.

  Patient problems: Bone Fracture(s)

  MAUDE report 7385479 ↗
• InjuryMar 30, 2018Crack; Nonstandard Device; Self-Activation or Keying; Unintended Movement

  UPON STANDING (THE COMPANY REPRESENTATIVE WHO WAS IN TOUCH WITH THE USER BELIEVES IT WAS THE SECOND SIT TO STAND DURING THE SESSION), THE LEFT HAND (LH) FRONT KNEE BRACKET (FKB) CRACKED AND THE DEVICE RETURNED TO SIT POSITION. THE USER WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH BROKEN LEG (RIGHT LEG).

  Patient problems: Bone Fracture(s)

  MAUDE report 7385462 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160987. One submission often covers many models, so check the product and lot details in each record.

• Z-1553-2021 · Feb 28, 2020 · Terminated
  ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord
• Z-0944-2018 · Aug 14, 2017 · Terminated
  ReWalk Personal 6.0. Catalog number: 50-20-0004.