Invacare initiates recall

Friday, October 18, 2013

ELYRIA, Ohio – Invacare has a big ask for HME providers.

On Oct. 2, Invacare sent providers a packet of information on a widespread recall of certain joysticks and driver controls on power wheelchairs manufactured between Oct. 1, 2006, and March 21, 2013. The ask: Using the provided serial numbers, identify customers who received wheelchairs with these products, remove them and swap them out for new ones.

“We know a lot is being asked of our provider customers,” said Lara Mahoney, director of investor relations and corporate communications. “But if there’s an issue related to patient safety, we have to recall the product. We take that very seriously.”

Invacare is recalling SPJ+ Joysticks and MK6i Driver Controls (excluding all ASL, Sip-n-Puff and Switch control systems) due to a defect that may result in the wheelchair slowing down relative to the commanded speed and not recovering, causing it to drive at a reduced speed; or the wheelchair slowing down relative to the commanded speed and then recovering, causing it to accelerate unintentionally, according to a Aug. 20 notice posted to the company’s website.

While the defect occurs in only “a fraction of a percentage” of the products, it has led to four confirmed minor injuries, including bruising, and pinched fingers and hands, Mahoney said.

“In our analysis of complaint data—this is a wide range of data over time—there started to be something we saw as a trend that we needed to address,” she said.

To help make the recall as easy as possible, Invacare has made available a template letter that providers can use to notify patients and a support hotline (877-413-6008). It also plans to credit the accounts of providers that replace products related to the recall.

“They will tell us, ‘We need X number of joysticks,’ and we will send them repair kits,” she said. “When they send us the old joysticks, we will credit their account for the work they did.”

Invacare announced on Aug. 6 that it was considering repairing or replacing “an anomaly” in one of the components in all potentially affected power wheelchairs. The estimated cost: $3.8 million.

Initially, when Invacare identified the anomaly and reported it to the U.S. Food and Drug Administration (FDA), it proposed repairing or replacing the components for only affected wheelchairs.