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 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.
Sanofi is recalling all of its epinephrine injector devices from the U.S. and Canada, a potentially costly setback for the company as it competes for market share with rival drugmaker Mylan.
The FDA notified the public of a Class 1 recall of SynCardia Systems' Total Artificial Heart, saying a specific part of the device known as the Freedom Driver that operates and monitors the heart could fail.
ConforMIS had one of the most staggeringly successful med tech IPOs this summer. Its July IPO raised more than $155 million at a $15 share price. The custom 3-D printed orthopedic implant company saw its share price climb as high as almost $27--but all that ground has been lost on this week's news of a voluntary recall by the company.
Insulet said its long-troubled Billerica, MA, manufacturing plant is back on track on an earnings call earlier this month--just before the FDA offered details on the OmniPod recalls that were caused by inadequate standards compliance. In July, the company issued a voluntary recall of more than 400,000 OmniPod Insulin Management Systems, which are wearable insulin pumps.
The FDA recently deemed corrective actions to three devices as Class 1, reserved for situations in which "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
CareFusion is recalling 7,418 units of its Alaris Syringe infusion pump, a corrective action that the FDA just deemed Class 1. This marks CareFusion's ninth Class 1 recall of an Alaris device since 2010, according to the database.
Northwest Farm Food Cooperative has issued a voluntarily recall of frozen raw cat food that may be contaminated with salmonella, which can affect the animals consuming the product and poses a risk to humans handling the product.
Medtronic disclosed difficulties with almost 2,000 units of its latest model insulin pump, the MiniMed 640G, which had been distributed in 10 European countries, according to a recall notice just made by the FDA. This model had its European launch in January and is slated for a PMA submission later this year.