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

Class 2 Device Recall Assurity, Assurity

  • 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 2 Device Recall Assurity, Assurity see related information
Date Initiated by Firm August 28, 2017
Create Date November 24, 2017
Recall Status1 Open3, Classified
Recall Number Z-0030-2018
Recall Event ID 78093
PMA Number P880086S283 
Product Classification implantable pacemaker Pulse-generator - Product Code DXY
Product Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224
Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
Code Information 96, 7073600, 7073592, 7073645, 7073628, 7073615, 7073659, 7073660, 7073216, 7074983, 7073233, 7074673, 7074681, 7074949, 7074950, 7074976, 7074979, 7074969, 7073194, 7074967, 7073670, 7072944, 7072949, 7072900, 7072904, 7072926, 7072303, 7072268, 7072960, 7074966, 2630330, 2630420, 2630369, 2620941, 2648288, 2630309, 2630316, 2630322, 2630332, 7073663, 2630327, 2630422, 2630345, 2630346, 2630340, 2630349, 2630362, 2630393, 2630410, 2634880, 2630335, 2630304, 7074667, 2630397, 2630399, 2630408, 2630411, 2630412, 2630413, 2630421, 2630416, 2630312, 2630409, 2620912, 2630384, 2630385, 2630395, 2630404, 2630405, 2630406, 2630407, 7074098, 2630383, 7074137, 7074672, 7073661, 7073662, 7073671, 7074099, 7074107, 7074102, 7074103, 7073653, 7074122, 7073646, 7074138, 7074141, 7074142, 7074143, 7074150, 7074146, 7074159, 7074168, 7074113, 7073591, 7072893, 7073247, 7073248, 7073249, 7073262, 7073263, 7073264, 7073254, 7073650, 7073581, 7074181, 7073586, 7073587, 7073605, 7073630, 7073624, 7073622, 7073635, 7073637, 7073276, 7074272, 2291309, 2299636, 2299285, 2346497, 2560969, 2300787, 2298349, 7074242, 7074169, 7074246, 2560908, 7074256, 7074251, 7074253, 7074277, 7074279, 7074639, 7074633, 7074655, 7074248, 2560962, 7073230, 7074173, 7074188, 7074214, 7074224, 7074233, 7074236, 2297756, 2289352, 2297841, 2302032, 2548677, 2342414, 2345957, 2345631, 2343417, 2346489, 2560925, 2561125, 7074170, 2464534, 2620816, 7073590, 2620793, 2620794, 2620802, 2620803, 2620790, 2620827, 2620821, 2620785, 2620811, 2620784, 2620847, 2620834, 2620832, 2620854, 2620855, 2620857, 2620858, 2620862, 2620822, 2620694, 2560958, 7073580, 7073597, 7073598, 7073640, 2620625, 2620688, 2620644, 2620782, 2620638, 2620875, 2620714, 2620732, 2620733, 2620742, 2620758, 2620769, 2620763, 2620773, 2620641, 2345964, 2620961, 2620963, 2620965, 2292930, 2342142, 2296600, 2296583, 2295942, 2620873, 2273684, 2620943, 2342879, 2296286, 2302055, 2297920, 2301106, 2343310, 2345207, 7072959, 2273528, 2620917, 7073260, 2620884, 2620880, 2620896, 2620898, 2620889, 2620886, 2620891, 2620960, 2620913, 2620956, 2620919, 2620920, 2620923, 2620926, 2620938, 2620935, 2620932, 2620952, 2620874, 2620901, 2620593, 7073579, 2620524, 2620538, 2620550, 2620585, 2620566, 2620567, 2620570, 2620515, 2620586, 2620498, 2620605, 2620606, 2620612, 2620622, 7074105, 7074127, 7074119, 7074125, 2620571, 2620417, 7059831, 2620537, 2620534, 2620513, 2620604, 2620359, 2620377, 2620382, 2620507, 2620433, 7074191, 2620425, 2620484, 2620488, 2620486, 2620491, 2620494, 2620496, 2620497, 2620444, 7072972, 7072937, 7072938, 7072950, 7072951, 7072952, 7072956, 7072958, 7072961, 7074189, 7072965, 7072930, 7073209, 7073212, 7073217, 7073224, 7073225, 7073252, 7073268, 7073271, 7072963, 7072895, 2346275, 7070426, 7070211, 7070468, 7070578, 7070622, 7072878, 7072885, 7072936, 7072881, 7072932, 7072892, 7072899, 7072908, 7072910, 7072912, 7072916, 7072925, 7072929, 7074190, 7072880, 2620814, 2620542, 2620757, 2620746, 2620760, 2620765, 2620772, 2620776, 2620779, 2620751, 2620801, 2620730, 2620835, 2620841, 2620823, 2620818, 7074166, 7074144, 7074149, 7074185, 2620789, 2620702, 2561079, 2620581, 2620595, 2620601, 2620621, 2620639, 2620640, 2620631, 2620752, 2620646, 7074199, 2620705, 2620712, 2620717, 2620718, 2620720, 2620722, 2620726, 2620729, 2620642, 7075300, 7074218, 7074282, 7074656, 7074652, 7074641, 7074942, 7075256, 7075264, 7074193, 7075298, 7074207, 7070607, 7070567, 7072274, 7072009, 7071997, 7072915, 7072905, 2620959, 7075282, 7074637, 2620552, 7074254, 7074249, 7074228, 7074268, 7074257, 7074278, 7074288, 7074259, 7074634, 7074255, 7074963, 7074968, 7073195, 7072889, 7073250, 7073261, 7073658, 7073652, 7074198, 7074290, 7074644, 2620580, 7074240, 7074241, 7074269, 7074266, 7074614, 7074616, 7074642, 7074177, 7074649, 7074192, 7074645, 7074651, 7074679, 7074705, 7074706, 7074682, 7074683, 7076236, 7074648, 7073656, 2294986, 2343534, 7073620, 7073621, 7073616, 7073617, 7073623, 7073644, 7074230, 7073655.
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
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action Abbott sent an Important Cybersecurity Advisory dated August 28, 2017, to all affected customers to notify customers of the availability of the programmer software update and associated pacemaker firmware update. The notification material is in the form of a Physician Letter and Hospital Letter and will be delivered to physicians and hospitals with inventory in the US by overnight service. Customers with questions were instructed to contact their Abbott representative or the customers technical support hotline at 1-800-722-3774.
Quantity in Commerce 529912 units
Distribution Worldwide 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 = DXY and Original Applicant = St. Jude Medical, Inc.
-
-