Audience: Risk Manager, Biomedical Engineering, Neurosurgery
ISSUE: FDA and Ad-Tech notified healthcare professionals of a Class 1 recall due to concern the microelectrodes are defective and may cause injury to the brain. These devices are intended for temporary (less than 30 days) use on patients with epilepsy for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. There is the potential for abrasion of brain tissue and for broken pieces to remain in the brain tissue when the physician removes the electrode. This may lead to hemorrhaging or a seizure, as well as death.
BACKGROUND: There has been one reported serious injury that may have been related to the use of the device. On Dec. 18, 2012, the firm sent its customers an "Urgent Medical Device Recall" letter. The letter described the reason for recall, the risk to health, actions to be taken by the customers, product and distribution information, and type of action taken by the firm. The recalled products were manufactured from June 2006 to March 2012, and distributed from June 8, 2006 to March 14, 2012.
RECOMMENDATION: Catalog, Lot, and Batch Numbers can be found in the firm press release below.
Actions to be taken by customers:
- Set aside all recalled products for return to the firm
- If products are further distributed, notify customers about the recall
- Return the Acknowledgement and Receipt Form.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[12/18/2012 - Recall Notice - FDA]
[02/28/2013 - Firm Press Release - Ad-Tech]