Enpath Medical, Inc Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical Systems, Inc. 1 Shelia Drive, Tinton Falls, NJ; Part No. 0208-2100-001, provided to Angel Medical Systems for International Clinical Studies; Sterile/ EO, Single Use. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.

Recommended Action

Per FDA guidance

On July 7th, Enpath determined that a recall of Model 501206 and 501214 Adapters should be initiated and contacted customer via telephone and formally notified via letter on July 10, 2006. On July 14th, Enpath determined that a recall of Model 501204, Model 501205 and Angel Medical Model LA-001 Adapters should be initiated and two more consignees were notified via telephone on July 17th and both formally notified via letter on July 18, 2006. Enpath requested that customers segregate and return any product from the lot numbers listed in the letter, cease distribution of these devices and notify customers.

Distribution

As reported by FDA

CA, MN, NJ