America’s Unsafe Medical Products

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Draeger Medical Breathing and Anesthesia Sets
> Issue date: January 25, 2019
> Type of alert: Recall

The company is recalling 1,200 VentStar and ID breathing circuits and anesthesia sets sold in the United States to provide mechanical ventilation and critical breathing support to patients. The devices may have been incorrectly assembled, resulting in a short-circuit in the breathing hose. That may lead to irreversible patient harm, up to and including death. This is a Class I recall.

Torrent Pharmaceuticals Losartan Tablets
> Issue date: January 22, 2019
> Type of alert: Recall

Torrent is expanding a voluntary recall of two types of losartan tablets used to treat hypertension. Six lots of losartan potassium and hydrochlorothiazide tablets were found to have trace amounts of an unexpected carcinogen in tablets manufactured by Hetero Labs. The company has received no reports of adverse events related to this recall.

Treating Peripheral Arterial Disease
> Issue date: January 17, 2019
> Type of alert: Letter to health care providers

The FDA notified peripheral interventionists and vascular medicine physicians that a recent meta-analysis of randomized trials of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease suggests a “possible increased mortality rate after two years” compared to patients treated with non-coated balloons or bare-metal stents.

Medtronic Cranial Surgery Navigation System
> Issue date: January 8, 2019
> Type of alert: Recall

Medtronic’s Synergy cranial system and StealthStation S7 cranial software are being recalled following reports that incorrect information is being displayed during biopsy procedures. If the defect should occur, “the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient’s healthy tissue, brain or blood vessels.” The recall was initiated in September 2018 and has been designated a Class I recall, the FDA’s most serious category. Using these devices may cause injuries or death.

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