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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
Recall Date January 20, 2016
Recall Status1 Open
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Original Applicant = St. Jude Medical, Inc.
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