Oscar Recalls Pacing Leads Due to a Connection Cap Malfunction

A Florida-based medical device company is recalling certain lots of its temporary bipolar pacing leads that are used for temporary pacing and sensing of the heart in conjunction with a compatible external pulse generator. Palm Harbor, FL-based Oscor Inc. offers contract development and manufacturing services to the medical device industry. The company said it initiated the voluntary recall because of a connector cap malfunction that has been linked to four serious injuries in the past six years. No deaths have been reported, however, the company said that death is a potential concern if the connector cap housing slides during use, exposing the connection wire. Find pre-qualified medical device suppliers on the Qmed Supplier Directory and meet suppliers at one of our upcoming events. The impacted device is the company's TB Unshrouded Bipolar Pacing Leads, which feature 2mm unshrouded connectors. If the connector cap housing slides and exposes the connection wire during use it could cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables, which in turn could cause an interruption of the pacing system. For patients who are pacing dependent, such an interruption could result in serious injury or death, the company said. After analyzing returned devices, Oscor said it determined that the failure was due to a design change of the cap housing of the pin...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news