Dive Brief:
- Germany’s Oscor is recalling its TB Temporary Bipolar Pacing Leads because the devices could become separated from the external pulse generator.
- FDA has categorized the recall as Class I, meaning the problem could lead to serious injury or death. Four serious injuries were reported to Oscor during the past six years that were attributed to a connector cap malfunction. No deaths were reported.
- Oscar plans to replace the product as needed with a Helios Temporary Pacing Lead or refer customers to an alternate supplier of FDA- and CE-approved temporary leads.
Dive Insight:
The leads are used in the treatment of patients with arrhythmias to stimulate the heart and increase the heart rate. The connector of the lead is attached to an external pacing pulse generator for energy. A physician advances the lead through a vein until the tip touches the inside of the heart, where it provides heartbeat sensing and pacing.
Oscor is recalling the TB Temporary Bipolar Pacing Leads because the connector cap housing may slide and expose an internal wire. An analysis of the returned devices attributed the failure to a design change of the cap housing.
The problem could result in a loss of connectivity, or the leads could break during movement and prevent the attached external pulse generator from pacing. Loss of pacing may lead to slow heart rate, lightheadedness, passing out or death.
The recall affects 4,778 devices in the United States that were manufactured between Dec. 21, 2011 and April 4, 2018 and distributed from Dec. 21, 2011 to May 17, 2018.
The company notified customers on Sept. 26, 2018 and Nov. 9, 2018. Hospitals were instructed to examine inventory for affected devices, quarantine the products and return them to Oscor. Distributors were instructed to examine their inventory, notify customers if affected devices were distributed, retrieve the devices and return them.
