The FDA has issued a Class I recall of the LifeStent Solo Vascular Stent manufactured by Bard Peripheral Vascular Inc.  Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.  The LifeStent Solo Vascular Stent is an implantable self-expanding stent and delivery system used to improve the inner open space of a blood vessel (luminal diameter) in the treatment of lesions caused by the abnormal narrowing in a blood vessel (symptomatic de-novo or restenotic lesions).  The recall is being issued because the stent's deployment mechanism may not perform properly when used.  Deployment issues range from failure to deploy, partial deployment, and difficult deployment.  These issues may cause serious adverse health consequences, including possible complications of bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death.

[1] FDA Medical Device Recall "Bard LifeStent Solo Vascular Stent - Failure to Deploy Stent" (September 30, 2013).

Nova Diabetes Care initiated a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max Plus glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall.

The company has recently determined that some of the blood glucose test strips contained within the indicated Nova Max Glucose Test Strip lots and Nova Max Plus glucose meter kits may report a false, abnormally high blood glucose result. A false abnormally high blood glucose result could, under certain conditions, result in an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.

[1] FDA Safety Information, "Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood Glucose Result" (July 29, 2013).

Following mounting evidence that their Riata leads were prone to premature erosion of the insulation around the electrical conductor wires, in 2011 St. Jude Medical recalled the implantable cardiac defibrillator (ICD) leads.   St. Jude stopped selling the Riata leads in late 2010, but more than 227,000 of the leads were distributed and thousands remain implanted in patients worldwide.  Insulation failure may cause some of the electrical conductors inside Riata leads to malfunction.  Malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shocks, which could result in serious adverse events, including death.  St. Jude has now introduced two newer lead products, the Riata ST Optim and Durata, that it claims are free of the problems that plagued the Riata model.  
[1] FDA Safety Communication: "Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc. (Sept. 24, 2013).

After reviewing updated safety and risk information, FDA changed the indications for use and labeling for Stryker’s Wingspan Stent System (“Wingspan”) by limiting approval to a very specific group of patients who are at serious risk of lifte-threatening stroke and have limited alternative treatment options.   The Wingspan should not be used for:

•  the treatment of stroke with an onset of symptoms within seven days or less, or
•  for treatment or for the treatment of transient ischemic attacks (TIAs).  
  

Wingspan is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Stenosis, or narrowing of the intracranial arteries, is a serious condition caused by a buildup of plaque within the arteries, and there are few treatment options available for managing this condition. Patients with intracranial stenosis are at serious risk of life-threatening strokes due to reduced blood flow to the brain from narrowed or blocked arteries. The Wingspan stent is intended to reopen narrowed arteries in certain patients to potentially prevent additional strokes. 
[1] FDA Safety Communication, "Narrowed Indications for Use for the Stryker Wingspan Stent System" (January 31, 2013).