Latest Headlines

Latest Headlines

Cook Medical recalling 17,000+ catheters and pressure monitoring sets due to tip separation

Cook Medical is recalling 17,827 single-lumen central venous catheters and pressure monitoring sets and trays because of concerns about catheter tip fracture and/or separation. The FDA posted the Bloomington, IN's company's recall on its website, an action it takes from time to time to publicize recalls that are critical to patient safety.

FDA hits Dräger Medical with another Class I ventilator recall

Telford, PA's Dräger Medical warned customers that the alarm on more than 400 of its ventilators may inadvertently go off and cause the device to stop functioning. Dräger said that personal injury was not reported in any of those situations.

FDA signs off on 2 of 5 companies producing duodenoscope cleaners

The FDA has now signed off on two out of the 5 manufacturers making automated endoscope reprocessors that are labeled for use with duodenoscopes: Cantel's Medivators and its Advantage Plus and DSD Edge as well as Steris and its System 1E Liquid Chemical Sterilant Processing System.

UPDATED: St. Jude recalling some defibrillator leads due to damaged insulation

Last year St. Jude Medical agreed to pay $14.25 million to settle 950 pending legal claims related to its riata defibrillator leads. So news of a Class 1 recall of 447 Optisure defibrillator leads due to a manufacturing defect that may have introduced damage to the wires' insulation is rather unsettling.

FDA alerts public of risks posed by Stryker's recalled drainage set

The FDA warned of the possibility of Stryker's Fuhrman Pleural/Pneumopericardial Drainage Set breaking in the membrane that surrounds the lung, a potentially fatal complication.

Manufacturer recalls three ventilator models because they may shut down unexpectedly

eVent Medical is recalling the LS, 5i and 7i Inspiration ventilators because of a faulty switch on the ventilator's power board may fail, causing the device to shut down without sounding an alarm, according to the FDA's latest safety alert.

Troubled Insulet recalling additional 18 lots of wearable insulin pump due to needle failure

Insulet's bad year continued, as the company revealed a voluntary recall of 18 lots of the wearable OmniPod pump for insulin delivery, including 15 lots distributed in the U.S.

UPDATED: Novartis' Alcon recalling more intraocular lenses in Japan due to reports of postoperative inflammation

Novartis' Alcon expanded the recall of its intraocular lenses in Japan, pushing the number of affected units to 89,042, due to a continued increase in reports of postoperative inflammation among patients who received the AcrySof IQ Toric lens.

FDA warns of 9 deaths due to coatings on minimally invasive intravascular medical devices

The U.S. Food and Drug Administration has issued a safety communication regarding a wide array of intravascular implanted devices and delivery tools that have coatings designed to reduce friction and improve maneuverability.

Quest Medical launches recall for open heart surgery drug delivery devices

Quest Medical has recalled delivery sets for its perfusion device for open heart surgeries after the company discovered issues with seals for the product that could lead to patient blood loss.