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Recall Issued for St. Jude’s Optisure Dual Coil Defibrillation Lead

Paige Tears-Gladstone10 months ago

The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall of the St. Jude Optisure dial coil defibrillation leads installed in patients to control irregular heartbeats.

Regarding the Optisure Defibrillation Lead Recall

According to the FDA, the Optisure dual coil defibrillation leads are being recalled by St Jude due to a manufacturing error. This error can result in cardiac arrest for patients with severe heartbeat variations as the lead may be incapable of delivering the current necessary to revive heartbeat 0 this can result in the patient's death.

281 of these units have been recalled in the United States and affected patients are advised to contact their health care providers and ask if their device utilizes DynamicTx Technology, which allows doctors to control the device and thereby ensure the defibrillator continues to deliver therapy despite a damaged lead.  

Description of the Recalled Difibrilation Leads

  • Affected unites were manufactured from March 12, 2014 to March 22, 2015
  • The products distributed from April 9, 2014 to October 20, 2015
  • At risk model numbers include: LDA220, LDA220Q, LDA230Q, LDP220Q

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