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FDA designates recall of temporary pacing leads as class 1

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The FDA has designated the product recall of temporary bipolar pacing leads as class 1, the most serious kind. The recall affects 4,778 pacing leads manufactured and distributed between Dec. 21, 2011, and May 17, 2018.

The connector cap housing of the pacing lead (TB temporary bipolar pacing leads, Oscor) for patients with arrhythmias may slide, causing internal wire exposure. This can lead to connectivity loss or breakage as cables move, according to a MedWatch report from the FDA.

The agency wrote that these movements may also prevent the external pulse generator from pacing, which may result in a slow heart rate and symptoms such as passing out, lightheadedness or death.

Oscor distributed a notice to customers on Sept. 26 and Nov. 9, alerting them to examine their inventory for affected leads, set them aside and return the leads to the company, according to the report. The company plans to replace leads on an as-needed basis with another lead (Helios temporary pacing lead) or guide their customers to another supplier of FDA-approved temporary leads.