FDA: Class I recall of Optisure Dual Coil Defibrillation Leads

Editor's Note

The Food and Drug Administration (FDA) on January 27 classified the recall of St Jude Medical’s (St Paul, Minnesota) Optisure Dual Coil Defibrillation Leads as Class I, the most serious.

The recall was initiated because of a manufacturing error that may have damaged the insulation layer of one of the shock coils. This could result in the inability of the implantable cardioverter defibrillator to deliver electrical therapy to the patient.

Model numbers are: LDA220, LDA220Q, LdA230Q, and LDP220Q.

UPDATED 01/27/2016 Firm Press Release added. [Posted 01/26/2016] AUDIENCE: Risk Manager, Patient ISSUE: St. Jude is recalling the Optisure leads due to a manufacturing error that may have caused damage to the insulation layer of one of the shock coils.