FDA-Device2016-01-27Class I
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
St Jude Medical Cardiac Rhythm Management Division
Hazard
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
Sold states
Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.
Affected count
447 units total (281 units in US)
Manufactured in
15900 Valley View Ct, N/A, Sylmar, CA, United States
Products
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0660-2016Don't want to check this manually?
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