ResMed CPAP masks recall is Class I

The AirTouch N20, one of the devices affected by the corrective action. [Image from ResMed]The FDA announced that ResMed’s voluntary recall of millions of CPAP mask magnets is now Class I, the agency’s most serious level.

Last month, ResMed (NYSE: RMD) +   warned CPAP users about potential magnetic interference when magnets go near certain implants and medical devices in the body.

People using CPAP masks with magnets only need to return them if they’re contraindicated. ResMed instead instructed people using the masks to keep the magnets at least 6 in. away from implants or medical devices that could be affected — and to check with physicians and device makers about whether magnetic fields could negatively affect an implant.

ResMed also has an updated webpage with information about the potential problems.

More about the ResMed CPAP masks recall

In its announcement yesterday of the Class I des…

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ResMed is cutting its workforce as it seeks to refocus

ResMed (NYSE: RMD) + announced that it is reducing its workforce by about 5% as part of a restructuring it plans to complete in the present quarter.

The San Diego–based maker of CPAPs and other respiratory devices listed a headcount of 8,160 in its most recent annual report, which means roughly 400 workers could be affected.

“Decisions like this that impact people are never easy. However, we know that we are doing the right thing, and we’re doing the right thing to accelerate our growth and to refocus on our long-term mission,” CEO Mick Farrell said during the company’s earnings call yesterday evening.

ResMed has seen its revenue spike amid the massive recall at competitor Philips, but the growth may be slowing. Revenue was up 16% year-over-year to $1.1 billion in the first quarter that ended Sept. 30, 2023. It was up 23% in the previous quarter.

“We have stopped some project…

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ResMed shares near 52-week low after disappointing results

ResMed (NYSE: RMD) + shares are down on fourth-quarter sales and profits that missed Wall Street’s expectations.

The device manufacturer’s stock was trading around $183.58 per share near noon, approaching the 52-week low of $181.50.

The stock hasn’t closed below $188 since April 2021, when competitor Philips initiated a recall of millions of continuous positive airway pressure (CPAP) devices.  ResMed has had the CPAP device market to itself since then.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — is relatively unchanged today.

The San Deigo–based sleep respiratory technology maker posted profits of $228.7 million. That amounts to $1.56 per share on sales of $1.12 billion for the quarter ended June 30, 2023.

ResMed profits decreased 18% compared to the prior-year quarter but posted sales growth of 23%.

Adjusted to e…

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How Philips’ significant respiratory devices recall unfolded

There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s how the Philips Respironics recall got to this point.

Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could potentially degrade and get into the airways.

Fast forward a year and a half, and Philips is still effectively out of the respiratory devices market as it works to repair the devices. FDA presently has 90,000 reports of problems — including 260 mentioning deaths.

Philips CEO Roy Jakobs has said the Dutch medtech giant is deeply sorry about the recall.

Meanwhile, competitor ResMed has struggled amid supply chain challenges to fill the resulting CPAP shortage. ResMed CEO Mick Farrell said this week that patients in some parts of the world have to wait up to 12 weeks to receive a CPAP after a sleep apnea diag…

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