Medtronic Class I Recall of Kappa and Sigma Series Devices

C. Todd Alley — Mon, 22 Jun 2009 12:51:35 GMT

Medtronic, in conjunction with the FDA, has issued Class I recall – the most serious type of recall classification reserved for products whose continued use could lead to serious illness or death - of the following lines of pacemakers:

· Medtronic Kappa Series 600/700/900

· Medtronic Sigma Series 100/200/300

The recall has been issued because of a serious risk of operational failure. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. Pacemaker-dependent patients may experience serious injury or even death. Most of the pacemakers affected by this recall have been implanted in patients for five years or longer.

Alley, Clark & Greiwe has been involved with Medtronic litigation for years, and our attorneys have been directly involved with other Medtronic recalls (including Medtronic Sprint Fidelis Leads and Medtronic Implantable Cardioverter Defibrillators (ICD) devices). While it’s unfortunate that another model line has been recalled, it is not particularly surprising. Please contact our office and we will help you determine if a particular pacemaker is part of this recall.

Originally posted at InjuryBoard by C. Todd Alley

Recall of Digitek (Digoxin Tablets)

Brenda Fulmer — Thu, 08 May 2008 15:39:07 GMT

U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration along with Actavis Totowa (formerly Amide Pharmaceutical) recently announced the recall of Digitek (digoxin) tablets that are distributed in the United States by Mylan Pharmaceuticals (under a "Bertek" label) and UDL Laboratories. The recall was initiated due to manufacturing defects in the Digitek tablets that caused the pills to be double the appropriate thickness and, as a result, double the expected strength. Digitek (digoxin tablets) are powerful drugs used to treat heart rhythm abnormalities. Patient who receive an overdose of this medication could suffer life-threatening toxicity, especially in patients with pre-existing kidney disease or renal failure. Symptoms of Digitek toxicity include: nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia (abnormal heart rhythm). According to the FDA, there have been several reports of illnesses and injuries reported in connection with the defective manufacture of the Digitek tablets.

Originally posted at InjuryBoard by Brenda Fulmer

Tampa Bay Personal Injury Lawyer - recall

Medtronic Class I Recall of Kappa and Sigma Series Devices

Recall of Digitek (Digoxin Tablets)