SmartDrive® MX2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00861896000303), received between Oct 24, 2017 and Jan 11, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Shut Off” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K151199); 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 11, 2021Unintended Movement; Insufficient Device Problem Information; Unintended Movement; Insufficient Device Problem Information

  THE CLIENT WAS OPERATING THE SMARTDRIVE WITH HIS CHAIR UP A RAMP AT A LOCAL GAS STATION. THE CLIENT STATED THAT THEY ATTEMPTED TO SHUT DOWN THE DEVICE ONCE AT THE TOP OF THE RAMP, BUT THE UNIT CONTINUED TO PROPEL THE CLIENT. THE SECONDARY ACTION WAS THE CLIENT CHAIR AND SMARTDRIVE UNIT PROPELLED OFF A CURB. THE CLIENT SUSTAINED AN INJURY THAT REQUIRED STITCHES.

  Patient problems: Head Injury; Skin Tears

  MAUDE report 11148093 ↗
• InjuryJan 4, 2019Failure to Shut Off

  AS DESCRIBED TO THE SALES REPRESENTATIVE BY THE USER'S REHAB COORDINATOR, USER WAS OPERATING SMARTDRIVE MODEL MX2 AND HE / SHE ALLEGEDLY COULD NOT GET THE DRIVING TO DEACTIVATE. UPON ATTEMPTING TO STOP THE UNIT MANUALLY, THE USER WAS THROWN FROM THE WHEELCHAIR. AS A CAUSE OF BEING EJECTED FROM THE WHEELCHAIR THE USER SUSTAINED A BROKEN LEG.

  Patient problems: Bone Fracture(s)

  MAUDE report 8220287 ↗
• InjuryOct 5, 2018Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem; Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem

  AS DESCRIBED TO THE TECHNICAL SUPPORT REPRESENTATIVE BY THE USER, USER WAS OPERATING SMARTDRIVE MODEL MX2+ AND, AFTER FAILING TO [1] RECOGNIZE THAT NO POWER ASSIST FROM THE DEVICE IS NEEDED WHEN GOING DOWN A DECLINE (TO WHICH IT SHOULD BE DEACTIVATED / TURNED OFF AS INSTRUCTED IN THE DEVICE LABELING), [2] MAINTAIN A SLOW SPEED WHEN GOING DOWN A TWO-TIERED RAMP REQUIRING A TURN AND [3] SUCCESSFULLY DEACTIVATE THE POWER ASSIST DRIVING / STOP THE WHEELCHAIR / NAVIGATING THE TURN ON THE RAMP BEFORE CONTINUING, HE / SHE ALLEGEDLY COULD NOT GET THE DRIVING TO DEACTIVATE. UPON COMING TO THE TURN IN THE RAMP THE USER INSTEAD CONTINUED FORWARD OFF THE END. AS A CAUSE OF THE APPROXIMATELY 4 FT. FALL WHICH HAD THE CONSEQUENCE OF THE USER'S KNEE IMPACTING INTO THE GROUND, THE USER SUSTAINED A BROKEN HIP IN MULTIPLE PLACES; NO DAMAGE WAS REPORTED TO BE DONE TO THE WHEELCHAIR.

  Patient problems: Hip Fracture

  MAUDE report 7940853 ↗
• InjuryApr 20, 2018Detachment Of Device Component; Installation-Related Problem; Detachment Of Device Component; Installation-Related Problem

  AS DESCRIBED TO THE QUALITY SYSTEM MANAGER BY SALES REPRESENTATIVE, USER WAS OPERATING SMARTDRIVE MODEL MX2+ AND, AFTER FAILING TO RECOGNIZE THE ATTACHMENT HARDWARE WAS NOT INSTALLED / INITIALLY SET-UP AS INTENDED AND INSTRUCTED IN THE DEVICE LABELING, ALLEGEDLY HAD THE SMARTDRIVE / DRIVE UNIT COME OFF OF THE WHEELCHAIR. UPON THE SMARTDRIVE / DRIVE UNIT NO LONGER BEING ATTACHED TO THE WHEELCHAIR, THE USER THEN VEERED INTO AN EMBANKMENT. AS A CAUSE OF IMPACTING THE EMBANKMENT THE USER SUSTAINED A DISLOCATED KNEE (WHICH "WENT RIGHT BACK IN") AND NECK SOFT TISSUE INJURY ("WHIPLASH TYPE"); NO DAMAGE WAS REPORTED TO BE DONE TO THE WHEELCHAIR.

  Patient problems: Joint Dislocation

  MAUDE report 7449278 ↗
• InjuryJan 12, 2018Improper or Incorrect Procedure or Method; Failure to Shut Off

  AS DESCRIBED TO TECHNICAL SUPPORT BY USER, USER WAS OPERATING SMARTDRIVE MODEL MX2 - SMARTDRIVE / DRIVE UNIT SERIAL (B)(4) WITH WHAT IS SUSPECTED TO BE WRISTBAND SERIAL (B)(4) AND, AFTER FAILING TO TURN POWER-ASSIST OFF PRIOR TO GOING DOWN A RAMP AS INSTRUCTED / CAUTIONED AGAINST IN THE INSTRUCTIONS FOR USE (IFU), IT WAS CLAIMED THAT THE MOTOR ACTIVATED. USER ALSO CLAIMED THAT HE/SHE COULD NOT GET THE MOTOR TO DEACTIVATE, AND CONSEQUENTLY RAN INTO A CONSTRUCTION BEAM. THE USER BROKE HIS / HER FEMUR FROM THE IMPACT OF RUNNING INTO THE CONSTRUCTION BEAM WHILE IN THE WHEELCHAIR.

  Patient problems: Fracture, Arm

  MAUDE report 7188213 ↗
• InjuryOct 24, 2017Component Falling; Unintended Collision

  AS DESCRIBED TO MAX MOBILITY MANAGEMENT BY COURT FILINGS THAT USER WAS OPERATING SMARTDRIVE MODEL MX2 - SERIAL NUMBER UNKNOWN (NOT INITIALLY PROVIDED) AND "WHETHER DUE TO THE AWKWARD FALL OF [THE USER] OR DUE TO THE COLLISION BETWEEN [THE USER] AND THE WHEELCHAIR AS A RESULT OF THE WHEELCHAIR RUNNING HIM OVER, [THE USER] SUFFERED INJURY AND WAS HOSPITALIZED. X-RAYS REVEALED THE [USER] SUFFERED BROKEN BONES, INCLUDING A BROKEN LEG."

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 6974575 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151199. One submission often covers many models, so check the product and lot details in each record.

• Z-2540-2025 · Aug 12, 2025 · Open, Classified
  Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
• Z-2538-2025 · Aug 12, 2025 · Open, Classified
  Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
• Z-2539-2025 · Aug 12, 2025 · Open, Classified
  Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
• Z-1117-2025 · Dec 20, 2024 · Open, Classified
  Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
• Z-1116-2025 · Dec 20, 2024 · Open, Classified
  Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
• Z-2005-2023 · May 10, 2023 · Open, Classified
  PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX
• Z-2004-2023 · May 10, 2023 · Open, Classified
  PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX