Another defective medical device was recalled by the United States Food and Drug Administration which has announced a Class 1 recall of Ad-Tech Macro Micro Subdural Electrodes. The recalled microelectrodes were recalled amid concerns that the microelectrodes are defective and can cause brain injuries. The electrodes are manufactured by Ad-Tech Medical Instrument Corporation.
The recalled devices are intended for temporary use on epileptic patients to record, monitor and stimulate electrical signals on the surface of the brain. The electrodes can cause abrasions to the brain and broken pieces can remain in the brain tissue when the electrode is removed. These injuries could result in hemorrhaging, seizures or even death.
The FDA has received notification of one serious injury that may be linked to the use of the recalled device. On December 18, 2012, the manufacturer of the electrodes sent an “Urgent Medical Device Recall” letter to its customers.
The recalled electrodes were manufactured between June 2006 and March 2012 and were distributed from June 8, 2006 to March 14, 2012.
Class I recalls are the most serious classification of recalls initiated by the FDA. Products subject to Class I recalls have the potential to cause serious health problems or death.
For more information, visit the website of the Ohio defective medical device attorneys at Clark, Perdue & List.
“Ad-Tech Macro Micro subdural Electrodes” FDA Medwatch, March 7, 2013