The Recall Desk
HighFDA (Devices)·Z-1130-2022·Announced 2022-06-01

Invacare TDX SP2 Power Wheelchairs May Lose Power Due to Battery Harness Disconnection

Invacare TDX SP2 power wheelchairs may experience battery harness disconnection during shipment or use, resulting in loss of power. Approximately 133 affected devices have been distributed in the U.S. and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II FDA medical device recall for a documented mechanical defect that eliminates wheelchair functionality and creates risk of harm. However, no injuries or deaths have been reported in the source text, which per the rubric limits the score to 3 (High).

Plain-English summary

Invacare Corporation is recalling the TDX SP2 power wheelchair models TDXSP2, TDXSP2-MCG, and TDXSP2V. Approximately 133 units have been distributed nationwide across the United States and Canada.

The battery wiring harness on these wheelchairs may become disconnected during factory shipment or during normal use—particularly when traversing large obstacles or following jolts or impacts to the wheelchair. Disconnection of the harness results in complete loss of power to the wheelchair.

Users of affected wheelchairs should discontinue use and contact Invacare Corporation for inspection and repair of the battery harness.

The recalled product

Product
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Manufacturer
Invacare Corporation
Hazard
  • battery-disconnection
  • power-loss

Distribution

Distributed nationwide across the United States.