• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Unify and Unify Assura

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall Unify and Unify Assura see related information
Date Initiated by Firm August 28, 2017
Create Date October 10, 2017
Recall Status1 Open3, Classified
Recall Number Z-0004-2018
Recall Event ID 78068
PMA Number P030054S329 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q
Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
Code Information 27291, 827295, 827308, 827311, 827312, 827316, 827319, 827111, 827121, 827223, 827227, 827259, 827260, 827274, 827280, 827284, 827286, 827297, 827129, 827133, 827140, 827141, 7015864, 7015865, 619645, 619647, 619650, 619651, 619652, 619943, 619949, 619974, 620140, 619654, 619979, 619644, 827149, 827150, 827159, 827166, 827169, 827171, 827181, 827186, 827190, 827201, 827206, 827213, 827236, 827240, 827245, 827277, 827278, 827300, 827304, 7030695, 7017053, 7003577, 827155, 620141, 827122, 827146, 827151, 827221, 827225, 827263, 827299, 827315, 827309, 827235, 827251, 827296, 827234, 827271, 828077, 828086, 828088, 828090, 828098, 828103, 828114, 828126, 828128, 828129, 828133, 828182, 828186, 828191, 828113, 828116, 828192, 828202, 828229, 828369, 828371, 828385, 828387, 828389, 828392, 828393, 1049693, 1100924, 828394, 828397, 828399, 828428, 828439, 827203, 828112, 828160, 828378, 828381, 828383, 828404, 828407, 828409, 828412, 828424, 828425, 828426, 828437, 828440, 828442, 828443, 828444, 828448, 828449, 828452, 828454, 828459, 828462, 828464, 828466, 830610, 828197, 828143, 827176, 827233, 827261, 827305, 828415, 828416, 828427, 828450, 829301, 829306, 829308, 829311, 829317, 829322, 829323, 829324, 829325, 829331, 829332, 829334, 829340, 829343, 829345, 829347, 829348, 829352, 829355, 829359, 829364, 829367, 829369, 829376, 829378, 829383, 829390, 829395, 829396, 829410, 829411, 829418, 829420, 829440, 829441, 829444, 829448, 829458, 829460, 829461, 829468, 829471, 829479, 829485, 829492, 829512, 829526, 829528, 829529, 829540, 829545, 829570, 829576, 827170, 827132, 829360, 829363, 829366, 829373, 829374, 829384, 829389, 829393, 829403, 829419, 829427, 829433, 829442, 829447, 829452, 829455, 829463, 829466, 829473, 829478, 829489, 829490, 829496, 829497, 829500, 829501, 829504, 829506, 829518, 829522, 829531, 829532, 829534, 829544, 829548, 829550, 829554, 829560, 829561, 828200, 829297, 829388, 828136, 829349, 828374, 829290, 829291, 829295, 829319, 829339, 829350, 829382, 829387, 827301, 828073, 828075, 828078, 828084, 828093, 828108, 828118, 828125, 828135, 828137, 828162, 828163, 828164, 828165, 828166, 828169, 828171, 828172, 828173, 828176, 828177, 828178, 828195, 828201, 828205, 828212, 828215, 828217, 828218, 828219, 828220, 828221, 828228, 828231, 828233, 828071, 828080, 828091, 828395, 828441, 828230, 828375, 828384, 828463, 827237, 828380, 828401, 828402, 828405, 828433, 829407, 829416, 829465, 829519, 829288, 1138099, 1037395, 1045324, 1139277, 834200, 827303, 828132, 828134, 828159, 829587, 830599, 830618, 830619, 830656, 830657, 830672, 830673, 830679, 830694, 830697, 830653, 830693, 830698, 830883, 828107, 828110, 828115, 828161, 828211, 828373, 828390, 828398, 828445, 828198, 828372, 828419, 1021299, 843800, 1018666, 1134613, 1127180, 828382, 830569, 830574, 830583, 830586, 830587, 830589, 830593, 830595, 830597, 830605, 830606, 830608, 830614, 830615, 830617, 830620, 830623, 830625, 830630, 830635, 830636, 830637, 830643, 830668, 828434, 829303, 829313, 829409, 829437, 829538, 829541, 829546, 829547, 829557, 829563, 829568, 829572, 829580, 830675, 830681, 830684, 830695, 830702, 830706, 830708, 830710, 830884, 830885, 830890, 830891, 830585, 830594, 830609, 830613, 830650, 830899, 830910, 830911, 830912, 830914, 830915, 830918, 830928, 828175, 829401, 829481, 829511, 829513, 829524, 829564, 828408, 829293, 829488, 829337, 829379, 1066616, 830576, 830580, 830616, 830704, 829344, 829445, 829486, 830629, 830564, 830565, 830567, 830592, 830612, 830889, 830896, 830904, 830923, 830926, 830927, 830929, 830931, 830562, 830925, 831365, 1134608, 830686, 829566, 830591, 830638, 830678, 831303, 831311, 7016363, 619657, 619656, 638998, 639010, 641499, 7019448, 7011276, 638782, 638786, 638789, 638813, 639008, 638785, 638816, 638817, 639007, 639015, 639152, 639153, 7003350, 7016368, 7031730, 7004638, 7030708, 831320, 831328, 831338, 831345, 831583, 831595, 831600, 831609, 831620, 831634, 830596, 830920, 831578, 831585.
Recalling Firm/
Manufacturer
St Jude Medical Inc.
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Candace Steele Flippin
651-756-6293
Manufacturer Reason
for Recall
The device may exhibit premature battery depletion.
FDA Determined
Cause 2
Device Design
Action Abbott sent a Field notification letter dated August 28, 2017 to customers of the availability of the new Battery Performance Alert. The letter identified the affected product, problem and actions to be taken. The recalling firm posted a public statement on their website in the Abbott Media Room. The link to the statement is as follows: http://abbott.mediaroom.com/2017-08-29-Abbott-issues-new-updates-for-implanted-cardiac-devices. For questions contact your local Sales Representative or Abbott Technical Services at 1-800-722-3774.
Quantity in Commerce 89,109 units
Distribution US Nationwide Distribution
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 = NIK and Original Applicant = St. Jude Medical
-
-