Latest Headlines

Latest Headlines

Dexcom proposes Class I recall fix, 'on track' with Verily for next-gen glucose monitors

Dexcom is working to refocus in the wake of a recent Class I recall for its speakers that applied across several models of its continuous glucose monitors (CGM). The company has submitted a filing for a replacement speaker and related manufacturing changes with the FDA, it said on an April 27 earnings call.

Medtronic recalls battery pack used for patient monitoring devices

Medtronic is voluntarily recalling a battery pack used in some of its patient monitors due to a manufacturing defect, adding another piece of bad news to its recent string of woes.

FDA deems Vascular Solutions recall of hemostasis valve Class I

More than 5,000 hemostasis valves have been recalled by Vascular Solutions under a recall that's been deemed Class I by the FDA. That classification means the recalled device is a serious health risk or potentially could cause death.

Boston Sci discloses Class I recall for coronary artery clot-removal catheter

Boston Scientific is recalling all models of its Fetch 2 Aspiration Catheter. The recall of the thrombectomy catheter is due to shaft breakage complaints--and has been classified as Class 1 by the FDA, indicating that use of the device could result in serious adverse health consequences or death.

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.