Recall Class: Class I
Date Recall Initiated: Dec. 18, 2012
Products: Macro Micro Subdural Electrodes
Catalog, Lot, and Batch Numbers: See Firm Press Release under Additional Links below.
The products can be identified by the label provided on the packaging.
The recalled products were manufactured from June 2006 to March 2012, and distributed from June 8, 2006 to March 14, 2012.
Use: 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.
Recalling Firm:
Ad-Tech Medical Instrument Corporation
1901 William Street
Racine, Wisconsin 53404-1876
Reason for Recall: There is a concern the microelectrodes are defective and may cause injury to the brain. As a result, there is the potential for scraping (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.
Public Contact: Customers with questions may call the company at 1-800-776-1555 between 9:00 AM – 5:00 PM (Central Time). Customers may also contact the company by e-mail at customersupport@adtechmedical.com.
FDA District: Minneapolis District Office
FDA Comments:
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. Additionally, the firm issued a press release on Feb. 27, 2013.
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.
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
