LifeBand® Load-distributing Band Model 200 (REF 8700-001013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10849111002988), received between Mar 13, 2025 and Mar 5, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Material Twisted/Bent

  THE CUSTOMER REPORTED THAT DURING A DEMO, THEY PLACED A TORSO MANIKIN ON THE AUTOPULSE NXT PLATFORM (B)(6). THE PLATFORM AND NXT BAND (LOT # UNKNOWN) KEPT PROVIDING COMPRESSIONS; HOWEVER, THE BAND TWISTED ON ITS OWN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527305 ↗
• MalfunctionApr 2, 2025Retraction Problem; Use of Device Problem; Material Twisted/Bent; Retraction Problem; Use of Device Problem; Material Twisted/Bent

  DURING PATIENT RESUSCITATION WITH THE AUTOPULSE NXT PLATFORM, THE CREW OBSERVED A PROBLEM WITH AN NXT BAND (LOT #200888) THAT TWISTS INTERNALLY WITHIN THE DEVICE EVEN WHEN CORRECTLY ALIGNED ON THE PATIENT. THE FAILURE OCCURRED APPROXIMATELY 4 TO 5 MINUTES INTO OPERATION. A NOTICEABLE CHANGE IN THE SOUND OF THE AUTOPULSE MOTOR WAS NOTED, INDICATING THAT THE DEVICE WAS STRUGGLING AND BECOMING BOGGED DOWN. SHORTLY AFTER, IT STOPPED COMPRESSING. UPON ATTEMPTING A RESET, ONE SIDE OF THE BAND WAS DIFFICULT TO RETRACT, REVEALING THAT IT HAD BECOME BUNDLED WITHIN THE DEVICE. ADDITIONALLY, THE OUTER SLEEVE OF THE BAND APPEARED TO BE PULLED INTO ITSELF. AFTER RESETTING, THE BAND QUICKLY BECAME TANGLED AGAIN DUE TO THE CREASES AND FOLDS THAT HAD FORMED. ACCORDING TO THE CUSTOMER, THE PATIENT WAS OF AVERAGE SIZE. THE CREW REVERTED TO MANUAL CPR. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755098 ↗
• MalfunctionApr 2, 2025Retraction Problem; Use of Device Problem; Material Twisted/Bent; Retraction Problem; Use of Device Problem; Material Twisted/Bent

  DURING PATIENT RESUSCITATION WITH THE AUTOPULSE NXT PLATFORM, THE CREW OBSERVED A PROBLEM WITH AN NXT BAND (LOT #200888) THAT TWISTS INTERNALLY WITHIN THE DEVICE EVEN WHEN CORRECTLY ALIGNED ON THE PATIENT. THE FAILURE OCCURRED IMMEDIATELY UPON DEPLOYMENT. A NOTICEABLE CHANGE IN THE SOUND OF THE AUTOPULSE MOTOR WAS NOTED, INDICATING THAT THE DEVICE WAS STRUGGLING AND BECOMING BOGGED DOWN. UPON ATTEMPTING A RESET, ONE SIDE OF THE BAND WAS DIFFICULT TO RETRACT, REVEALING THAT IT HAD BECOME BUNDLED WITHIN THE DEVICE. ADDITIONALLY, THE OUTER SLEEVE OF THE BAND APPEARED TO BE PULLED INTO ITSELF. AFTER RESETTING, THE BAND QUICKLY BECAME TANGLED AGAIN DUE TO THE CREASES AND FOLDS THAT HAD FORMED. ACCORDING TO THE CUSTOMER, THE PATIENT WAS LARGER AND WELL WITHIN THE PARAMETERS OF THE AUTOPULSE. THE CREW REVERTED TO MANUAL CPR. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755073 ↗
• MalfunctionApr 1, 2025Retraction Problem; Use of Device Problem; Material Twisted/Bent; Retraction Problem; Use of Device Problem; Material Twisted/Bent

  DURING PATIENT RESUSCITATION WITH THE AUTOPULSE NXT PLATFORM, THE CREW OBSERVED A PROBLEM WITH AN NXT BAND (LOT #200888) THAT TWISTS INTERNALLY WITHIN THE DEVICE EVEN WHEN CORRECTLY ALIGNED ON THE PATIENT. THE FAILURE OCCURRED APPROXIMATELY 4 TO 5 MINUTES INTO OPERATION. A NOTICEABLE CHANGE IN THE SOUND OF THE AUTOPULSE MOTOR WAS NOTED, INDICATING THAT THE DEVICE WAS STRUGGLING AND BECOMING BOGGED DOWN. SHORTLY AFTER, IT STOPPED COMPRESSING. UPON ATTEMPTING A RESET, ONE SIDE OF THE BAND WAS DIFFICULT TO RETRACT, REVEALING THAT IT HAD BECOME BUNDLED WITHIN THE DEVICE. ADDITIONALLY, THE OUTER SLEEVE OF THE BAND APPEARED TO BE PULLED INTO ITSELF. AFTER RESETTING, THE BAND QUICKLY BECAME TANGLED AGAIN DUE TO THE CREASES AND FOLDS THAT HAD FORMED. ACCORDING TO THE CUSTOMER, THE PATIENT WAS OF AVERAGE SIZE. THE CREW REVERTED TO MANUAL CPR. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748818 ↗
• MalfunctionMar 13, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT WHILE INSERTING THE NXT BAND PINS INTO THE AUTOPULSE NXT PLATFORM SLOT, IT FELT LIKE THE PINS WENT IN FURTHER THAN THEY SHOULD HAVE. THE CUSTOMER MENTIONED THAT THE PINS ON TWO NXT BANDS (LOT #UNKNOWN) WERE SLIGHTLY OFFSET COMPARED TO THOSE ON THE FUNCTIONING NXT BANDS. ADDITIONALLY, THE CUSTOMER NOTED THAT THE BANDS MAY HAVE BEEN INSERTED INCORRECTLY. THE CUSTOMER HAD NOT EXPERIENCED SIMILAR ISSUES WITH THE OTHER NXT BANDS, AS THOSE PINS APPEARED EVEN AND NOT OFFSET. THE REPORTED PROBLEM OCCURRED DURING THE TRAINING SESSION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599076 ↗
• MalfunctionMar 13, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT WHILE INSERTING THE NXT BAND PINS INTO THE AUTOPULSE NXT PLATFORM SLOT, IT FELT LIKE THE PINS WENT IN FURTHER THAN THEY SHOULD HAVE. THE CUSTOMER MENTIONED THAT THE PINS ON TWO NXT BANDS WERE SLIGHTLY OFFSET COMPARED TO THOSE ON THE FUNCTIONING NXT BANDS. ADDITIONALLY, THE CUSTOMER NOTED THAT THE BANDS MAY HAVE BEEN INSERTED INCORRECTLY. THE CUSTOMER HAD NOT EXPERIENCED SIMILAR ISSUES WITH THE OTHER NXT BANDS, AS THOSE PINS APPEARED EVEN AND NOT OFFSET. THE REPORTED PROBLEM OCCURRED DURING THE TRAINING SESSION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599075 ↗