Oscar is recalling its TB Unshrouded Bipolar Pacing Leads, which feature 2mm unshrouded connectors. The company said the connector cap housing can slide and expose the connection wire during use, which ultimately could cause an interruption of the pacing system.Oscor Inc.
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.
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 pins. The company first notified customers of the voluntary recall on Sept. 26, and recently expanded the scope of the recall to include expired inventory for devices distributed between Dec. 21, 2011 and May 17, 2018. Oscor said the recall expansion is to ensure that the expired units are properly disposed of.
The recall includes a total of 4,778 units that were distributed in the United States. FDA has identified this as a Class I recall, marking it as the most serious type of recall.
The company said it plans to replace returned products as needed with a Helios Temporary Pacing Lead or refer customers to an alternate supplier of FDA and CE approved temporary leads.
A list of alternate pre-qualified suppliers can also be found in the Qmed Supplier Directory housed here on the MD+DI site.