NormaTec Normatec 3 / REJ6 / Leg SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810050281997), received between Jan 6, 2025 and Jul 25, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (6 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED CUSTOMER SERVICE VIA EMAIL AND REPORTED THAT WHILE CHARGING THE BASE UNIT (BATTERY PACK), IT CAUGHT FIRE. THE CUSTOMER AND DEVICE WERE IN SWITZERLAND AT THE TIME OF THE EVENT. THE CUSTOMER WAS NOT USING THE DEVICE WHEN THE EVENT OCCURED. THERE WERE NO INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610942 ↗
• MalfunctionJul 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED CUSTOMER SERVICE VIA EMAIL AND REPORTED THAT WHILE CHARGING THE BASE UNIT (BATTERY PACK), IT CAUGHT FIRE. THE CUSTOMER WAS NOT USING THE DEVICE WHEN THE EVENT OCCURED. THERE WERE NO INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609504 ↗
• MalfunctionJan 6, 2025Battery Problem; Battery Problem

  THE CUSTOMER CONTACTED CUSTOMER SERVICE VIA EMAIL AND REPORTED THAT WHILE CHARGING THE BASE UNIT (BATTERY PACK), IT CAUGHT FIRE. THE CUSTOMER FURTHER REPORTED THAT THE BOTTOM OF THE BASE UNIT "IS ENTIRELY BURNT OUT" AND HIS BED WAS DAMAGED. THE CUSTOMER WAS NOT USING THE DEVICE WHEN THE EVENT OCCURRED. THERE WERE NO INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE REPORTED DAMAGE WAS TO THE BATTERY PACK, WHICH HOUSES A LITHIUM-ION BATTERY SUPPLIED BY (B)(4)., A THIRD-PARTY SUPPLIER THAT HYPERICE NO LONGER USES FOR BATTERIES. NO DAMAGE TO THE DEVICE ITSELF WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078648 ↗
• MalfunctionJan 6, 2025Battery Problem; Battery Problem

  HYPERICE WAS NOTIFIED ABOUT A FIRE AT A PHYSICAL THERAPY CLINIC BY THE CLINIC'S INSURANCE CARRIER. THE DEVICE IS BEING EVALUATED AMONG MULTIPLE POTENTIAL CAUSES FOR THE FIRE. HYPERICE HAS REQUESTED ADDITIONAL INFORMATION FROM THE CLINIC AND ITS INSURER IN ORDER TO INVESTIGATE WHETHER A MALFUNCTION OCCURRED, BUT IT DOES NOT HAVE MORE DETAIL AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078642 ↗
• MalfunctionJan 6, 2025Battery Problem; Battery Problem

  THE CUSTOMER APPROACHED A NORMATEC FOUNDER AT AN EVENT AND REPORTED THAT WHILE CHARGING THE BASE UNIT (BATTERY PACK) A FAMILY MEMBER ALERTED THEM THAT THERE WAS SMOKE COMING FROM THE DEVICE. THE CUSTOMER WAS NOT USING THE DEVICE WHEN THE EVENT OCCURRED. THERE WERE NO INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE REPORTED DAMAGE WAS TO THE BATTERY PACK, WHICH HOUSES A LITHIUM-ION BATTERY SUPPLIED BY (B)(4)., A THIRD-PARTY SUPPLIER THAT HYPERICE NO LONGER USES FOR BATTERIES. NO DAMAGE TO THE DEVICE ITSELF WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078640 ↗
• MalfunctionJan 6, 2025Battery Problem; Battery Problem

  THE CUSTOMER CONTACTED THE GLOBAL PERFORMANCE TEAM THAT THEN PUT THE CUSTOMER THROUGH TO CUSTOMER SERVICE AND REPORTED THAT WHILE CHARGING THE BASE UNIT (BATTERY PACK) IN THE MIDDLE OF THE NIGHT, IT BURST INTO FLAMES. THE CUSTOMER WAS NOT USING THE DEVICE WHEN THE EVENT OCCURRED. THERE WERE NO INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE REPORTED DAMAGE WAS TO THE BATTERY PACK, WHICH HOUSES A LITHIUM-ION BATTERY SUPPLIED BY FUJAN SCUD POWER TECHNOLOGY CO., A THIRD-PARTY SUPPLIER THAT HYPERICE NO LONGER USES FOR BATTERIES. NO DAMAGE TO THE DEVICE ITSELF WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078639 ↗
• MalfunctionJan 6, 2025Battery Problem; Battery Problem

  THE CUSTOMER CONTACTED THE SALES REPRESENTATIVE THAT THEN PUT THE CUSTOMER THROUGH TO CUSTOMER SERVICE AND REPORTED THAT WHILE CHARGING THE BASE UNIT (BATTERY PACK), IT SPARKED AND CAUGHT FIRE. THE CUSTOMER WAS NOT USING THE DEVICE WHEN THE EVENT OCCURRED. THERE WERE NO INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE REPORTED DAMAGE WAS TO THE BATTERY PACK, WHICH HOUSES A LITHIUM-ION BATTERY SUPPLIED BY (B)(4), A THIRD-PARTY SUPPLIER THAT HYPERICE NO LONGER USES FOR BATTERIES. NO DAMAGE TO THE DEVICE ITSELF WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078628 ↗
• MalfunctionJan 6, 2025Battery Problem; Battery Problem

  THE CUSTOMER MADE A FACEBOOK POST AND CUSTOMER SERVICE REACHED OUT TO THE CUSTOMER WHO REPORTED THAT WHILE CHARGING THE BASE UNIT (BATTERY PACK) IN THE MIDDLE OF THE NIGHT, IT SPARKED AND CAUGHT FIRE. THE CUSTOMER FURTHER REPORTED THAT THIS CAUSED DAMAGE TO THE CARPET AND SIDE OF THE COUCH. THE CUSTOMER WAS NOT USING THE DEVICE WHEN THE EVENT OCCURRED. THERE WERE NO INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE REPORTED DAMAGE WAS TO THE BATTERY PACK, WHICH HOUSES A LITHIUM-ION BATTERY SUPPLIED BY FUJAN SCUD POWER TECHNOLOGY CO., A THIRD-PARTY SUPPLIER THAT HYPERICE NO LONGER USES FOR BATTERIES. NO DAMAGE TO THE DEVICE ITSELF WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078624 ↗