SmartDrive® MX2+Recalls & reported problems

Summary

The FDA's MAUDE database contains 858 adverse event reports that list this exact device (DI 00861896000310), received between Sep 28, 2021 and Aug 12, 2026 — classified as 23 injuries, 835 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (848 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 25 most recent of 858 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224543 ↗
• MalfunctionJun 22, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  THE END-USER REPORTS WHEN POWERING ON THE SMARTDRIVE DEVICE, CLAIMS THE DEVICE WILL IMMEDIATELY ENGAGE THE MOTOR WITHOUT ANY PHYSICAL COMMANDS BEING GIVEN FROM THE WEARABLE CONTROLLER. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578512 ↗
• MalfunctionJun 1, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  REPORTS HAVING ONGOING ISSUES WITH THE SMARTDRIVE CLAIMING THE WIRELESS CONTROL METHODS USED ON THE DEVICE WERE NOT WORKING CORRECTLY TO WHERE THEY WOULD ENGAGE A DRIVE COMMAND BY THEMSELVES OR LOSE DRIVE WITHOUT COMMAND. CLAIMS ON ONE OCCASION THE DEVICE WOULDN'T STOP WHEN GIVEN A TAPPING MOTION AND THEY TRIED TO STOP BY PUTTING FEET ON GROUND WHERE THEY INJURED THEIR TOE. NO MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: Abrasion

  MAUDE report 25348133 ↗
• MalfunctionMay 26, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING AS THE END-USER WAS USING THE SMARTDRIVE DEVICE WITH A SWITCH CONTROL BUTTON W/MONO JACK AND BUDDY BUTTON, REPORTED THAT THE DEVICE HAD BEEN SWITCHED OFF, BUT THE END-USER'S WHEELCHAIR REPORTEDLY TOOK OFF AND COULDN'T BE STOPPED. THE END-USER HAD TO CRASH INTO A BIN IN ORDER TO STOP IT. IT WAS FURTHER REPORTED THAT THE CLIENT FELL FROM THE WHEELCHAIR WHERE THEY REPORTEDLY SUSTAINED AN UNSPECIFIED INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

  Patient problems: Insufficient Information

  MAUDE report 25285057 ↗
• MalfunctionMay 20, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  REPORT OF SWITCH CONTROL W/MONO JACK AND BUDDY BUTTON HAVING BEEN PRESSED TO STOP, THEN UNEXPECTEDLY ENGAGED THE SMARTDRIVE MOTOR TO WHERE THE END-USER REPORTEDLY COULD NOT STOP WITH A PRESS OF THE CONTROLLER BUTTONS. NO INJURY WAS REPORTED TO HAVE OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233950 ↗
• MalfunctionMay 14, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING WHILE USING THE SMARTDRIVE WITH A SWITCH CONTROL W/MONO JACK AND A BUDDY BUTTON, THEIR PARTNER REPORTEDLY TOUCHED THE CONNECTION PLUG WHERE THE BUDDY BUTTON PLUGS IN AND THIS REPORTEDLY CAUSED THE SMARTDRIVE DEVICE TO ENGAGE A DRIVE COMMAND. REPORTS CLAIM IT CAUGHT THE END-USER OFF GUARD WHERE THEY LOST POSITIONING AND FELL FROM THE WHEELCHAIR. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174567 ↗
• MalfunctionMay 13, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING WHILE USING THE SMARTDRIVE WITH A SWITCH CONTROL W/MONO JACK AND A BUDDY BUTTON WHILE IN MOMENTARY SWITCH MODE, ON A COUPLE OF OCCASIONS WHEN RELEASING THE BUDDY BUTTON, CLAIMS THE DEVICE HAD CONTINUED TO DRIVE, FORCING THE USER TO PRESS THE BUTTON A SECOND TIME IN ORDER TO STOP. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165017 ↗
• MalfunctionApr 22, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  REPORTS WHILE SITTING AT A TABLE IN A RESTAURANT, THE SMARTDRIVE UNIT REPORTEDLY ENGAGED A DRIVE COMMAND WITHOUT PHYSICAL MANIPULATION OF THE CONTROLLER AND CLAIMS BEING UNABLE TO STOP THE MOTOR BY PRESSING THE SWITCH CONTROL BUTTON, REQUIRING A FRIEND TO TURN THE SMARTDRIVE OFF. NO INJURIES OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953012 ↗
• MalfunctionApr 22, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING WHILE THE END-USER WAS USING THE SMARTDRIVE MX2+ DEVICE VIA A SPEED CONTROL DIAL, WHILE DIAL IS IN A STAND-BY/NEUTRAL POSITION, THE DIAL WILL ENGAGE A DRIVE COMMAND WITHOUT PHYSICAL MANIPULATION. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953011 ↗
• MalfunctionApr 20, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  REPORTS WHILE DRIVING THEIR MANUAL WHEELCHAIR WHILE UNDER POWER WITH A SMARTDRIVE DEVICE WITH SWITCH CONTROL BUTTONS. REPORTS WHEN PRESSING THE SWITCH CONTROL TO STOP, CLAIMS THE DEVICE STARTED TO SLOW DOWN BUT THEN SPED UP AND CONTINUED UNDER POWER. THIS REPORTEDLY CAUSED THE END-USER TO PANIC AND TURN THE WHEELCHAIR WHERE THEY IMPACTED A WALL. NO SERIOUS INJURIES WERE RECEIVED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 24932295 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  REPORTS WHILE DRIVING DOWN A SIDEWALK WHILE UNDER POWER WITH THE SMARTDRIVE DEVICE, AT ONE POINT THE MANUAL WHEELCHAIR HIT DIP IN THE SIDEWALK CAUSING THE WHEELCHAIR TO STOP FORWARD MOMENTUM. REPORTS INDICATE WHEN THIS OCCURRED, THE SMARTDRIVE DEVICE CONTINUED TO DRIVE FORWARD AND ROLL UNDERNEATH THE WHEELCHAIR WHICH CAUSED THE END-USER TO LOSE POSITIONING AND FALL TO THE GROUND WHERE THEY RECEIVED A SERIOUS INJURY.

  Patient problems: Bone Fracture(s); Multiple Fractures

  MAUDE report 24900537 ↗
• MalfunctionMar 31, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  END-USER CLAIMS WHILE USING THEIR MANUAL WHEELCHAIR, EQUIPPED WITH A SMARTDRIVE AND SWITCH CONTROLS WITH MONO JACK AND BUDDY BUTTON, WHEN ATTEMPTING TO DISENGAGE THE DRIVE MOTOR BY PRESSING THE BUDDY BUTTON, CLAIMS THE MOTOR FAILED TO DISENGAGE FORCING THE END-USER TO MANEUVER THE WHEELCHAIR INTO A TREE. NO SERIOUS INJURIES WERE RECEIVED AS A RESULT.

  Patient problems: Limb Pain

  MAUDE report 24747527 ↗
• InjuryMar 17, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  END-USER CLAIMS WHILE USING THEIR MANUAL WHEELCHAIR, EQUIPPED WITH A SMARTDRIVE AND SPEED CONTROL DIAL, THE SMARTDRIVE UNIT REPORTEDLY ACCELERATED WITHOUT NOTICE CAUSING THE END-USER TO LOSE CONTROL OF THE WHEELCHAIR WHERE IT FLIPPED ON TO ITS SIDE. THIS REPORTEDLY RESULTED IN AN INJURY TO THE END-USER.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 24616779 ↗
• MalfunctionMar 9, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  PERMOBIL AB RECEIVED REPORT CLAIMING AS THE END-USER WAS UNDER POWER WITH A SMARTDRIVE DEVICE USING SWITCH CONTROLS. IT WAS REPORTED WHEN PRESSING THE SWITCH CONTROL TO DISENGAGE THE DRIVE MOTOR, THE DEVICE REPORTEDLY FAILED TO STOP. THIS REPORTEDLY CAUSED THE END-USER TO FALL OUT OF THEIR MANUAL WHEELCHAIR RESULTING IN MINOR INJURIES. NO MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: Abrasion; Bruise/Contusion

  MAUDE report 24548097 ↗
• MalfunctionMar 9, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING AS THE END-USER WAS UNDER POWER WITH A SMARTDRIVE DEVICE USING SWITCH CONTROLS. IT WAS REPORTED WHEN PRESSING THE SWITCH CONTROL TO DISENGAGE THE DRIVE MOTOR, THE DEVICE REPORTEDLY FAILED TO STOP AFTER MULTIPLE PRESSES WHICH REPORTEDLY FORCED THE END-USER TO IMPACT A WALL. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545853 ↗
• MalfunctionFeb 26, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING THE END-USER HAVING CONNECTION ISSUE WITH THE GALAXY 5 WATCH CAUSING A LOSS OF CONTROL WITH THE SMARTDRIVE UNIT WHERE THEY DID NOT HAVE THE ABILITY TO STOP VIA TAPPING GESTURES. NO INJURIES WERE REPORTED TO HAVE BEEN RECEIVED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462428 ↗
• MalfunctionFeb 26, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  REPORTS WHILE SITTING IN A CLASSROOM AT SCHOOL, THE SMARTDRIVE DEVICE REPORTEDLY ENGAGED A DRIVE COMMAND WITHOUT ANY PHYSICAL MANIPULATION OF THE SWITCH CONTROL BUTTONS. THIS REPORTEDLY FORCED THE WHEELCHAIR INTO A DESK WHERE THE END-USER SUSTAINED SOME BRUISING TO THEIR CHEST. NO MEDICAL INTERVENTION WAS SOUGHT AS A RESULT.

  Patient problems: Bruise/Contusion

  MAUDE report 24462427 ↗
• MalfunctionFeb 19, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING WITH THE SWITCH CONTROL WITH BUDDY BUTTON OPTION REPORTEDLY ACTIVATED THE SMART DRIVE WITHOUT ANY PHYSICAL MANIPULATION OF THE SWITCH. NO INJURIES WERE RECEIVED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395317 ↗
• MalfunctionFeb 19, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING WITH THE SWITCH CONTROL WITH BUDDY BUTTON OPTION REPORTEDLY ACTIVATED THE SMART DRIVE WITHOUT ANY PHYSICAL MANIPULATION OF THE SWITCH. NO INJURIES WERE RECEIVED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395316 ↗
• MalfunctionFeb 19, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING INCONSISTENT PERFORMANCE WITH THE SWITCH CONTROL WITH BUDDY BUTTON OPTION, CLAIMING ONCE ACTIVATED THE SMART DRIVE WOULD NOT SHUT OFF WITH A SECOND PRESS OF THE SWITCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387976 ↗
• MalfunctionFeb 16, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING WHILE THE END-USER WAS USING THE SMARTDRIVE MX2+ DEVICE VIA A SPEED CONTROL DIAL, WHEN ROTATING THE DIAL BACK TO THE STAND-BY/NEUTRAL POSITION TO STOP, THE MOTOR WOULD NOT DISENGAGE AND CONTINUED TO RUN. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345395 ↗
• InjuryFeb 16, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  REPORTS HAVING INSTANCES WHILE USING THE SMARTDRIVE DEVICE UNDER POWER, WHERE WHEN TAPPING THE APPLE WATCH TO DISENGAGE THE DRIVE MOTOR, THE UNIT CONTINUED TO DRIVE. THIS REPORTEDLY FORCED THE END-USER TO IMPACT A WALL WHERE THEY LOST POSITIONING AND FELL TO THE GROUND REQUIRING MEDICAL INTERVENTION.

  Patient problems: Concussion

  MAUDE report 24344770 ↗
• MalfunctionFeb 13, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  REPORTS WHILE IN A GROCERY STORE, THE SMARTDRIVE UNIT ENGAGED A DRIVE COMMAND WITHOUT ANY PHYSICAL MANIPULATION OF THE SWITCH CONTROL BUTTON, REPORTEDLY CAUSING THE END-USER TO IMPACT AN IMMOVEABLE OBJECT WITH THE WHEELCHAIR. NO SERIOUS INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: Bruise/Contusion

  MAUDE report 24332627 ↗
• InjuryFeb 2, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  REPORTS HAVING A FAILURE WHEN USING THE SC DIAL TO WHERE IT DID NOT DISENGAGE A DRIVE COMMAND WHEN THEY DEPRESSED THE DIAL FACE. REPORTS THIS FORCED THEM TO HIT A CURB CUT AND FALL OUT OF THE WHEELCHAIR WHERE THEY WERE INJURED REQUIRING MEDICAL INTERVENTION TO ADDRESS.

  Patient problems: Bone Fracture(s); Multiple Fractures

  MAUDE report 24233768 ↗
• MalfunctionJan 30, 2026Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  RECEIVED REPORT CLAIMING WHILE THE END-USER WAS USING THE SMARTDRIVE DEVICE VIA A BLUETOOTH WEARABLE (WATCH), THE DEVICE FAILED TO STOP WHEN GIVEN A TAPPING GESTURE. THIS REPORTEDLY FORCED THE END-USER TO MANEUVER INTO AN IMMOVABLE OBJECT TO STOP THE WHEELCHAIR. NO INJURIES WERE REPORTED TO HAVE BEEN SUSTAINED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221712 ↗

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