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U.S. Department of Health and Human Services

Class 1 Device Recall Optisure HV lead

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  Class 1 Device Recall Optisure HV lead see related information
Date Initiated by Firm November 03, 2015
Create Date January 21, 2016
Recall Status1 Open3, Classified
Recall Number Z-0660-2016
Recall Event ID 72569
PMA Number P950022 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product 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).

Code Information 49, BRG011150, BRG011156, BRG011157, BRG011158, BRG011160, BRG011161, BRG011172, BRG011182, BRG011198, BRG011199, BRG011478, BRH010161, BRH010172, BRH010173, BRH010184, BRH010226, BRH010232, BRH010241, BRH010242, BRH010270, BRH010282, BRH010283, BRH010288, BRH010306, BRH010336, BRH010382, BRH010429, BRH010438, BRH010444, BRH010446, BRH010500, BRH010521, BRH010543, BRH010566, BRH010568, BRH010581, BRH010585, BRH010600, BRH010602, BRH010614, BRH010622, BRH010624, BRH010625, BRH010626, BRH010627, BRH010631, BRH010632, BRH010634, BRH010646, BRH010647, BRH010665, BRH010666, BRH010667, BRH010686, BRH010764, BRH010766, BRH010767, BRH010921, BRH011458, BRH011459, BRH011460, BRH011474, BRH011475, BRH011476, BRH011487, BRH011498, BRH011502, BRH011503, BRH011505, BRH011512, BRH011518, BRH011523, BRH011525, BRH011546, BRH011547, BRH011549, BRH011642, BRH011652, BRL010010, BRP010075, BRP010076, BRP010077, BRP010125.
Recalling Firm/
Manufacturer
St Jude Medical Cardiac Rhythm Management Division
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Rachael Ellingson
651-756-2295
Manufacturer Reason
for Recall
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
FDA Determined
Cause 2
Process control
Action An Important Medical Device Advisory letter was sent to doctors on 11/3/15 to inform them of the recall by St. Jude Medical. The letter informs the doctors that St. Jude Medical identified that during the manufacturing process of a limited number of Optisure leads, a trim technique to remove excess medical adhesive around the SVC shock coil may have introduced damage to the leads insulation. The letter provides the doctors with the recommendations for patients with a potentially impacted Optisure lead connected to a device with Dynamic TX technology and for patients implanted with a potentially impacted Optisure lead connected to a device without DynamicTx technology. Doctors with questions about the advisory are instructed to contact their local Sales Representative or St. Jude Medical Technical Services at (800) 722-3774.
Quantity in Commerce 447 units total (281 units in US)
Distribution Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LWS and Original Applicant = St. Jude Medical, Inc.
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