Events

Recall of Device Recall LIFEPAK 12

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Emergency Response Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34947
  • Event Risk Class
    Class 2
  • Event Number
    Z-0710-06
  • Event Initiated Date
    2006-03-22
  • Event Date Posted
    2006-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44986
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    Therapy connectors may have connector sockets that do not meet design specs - short drill depth. interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.
  • Action
    On 3/22/06, the firm began sending out letters dated March 2006, and flagged URGENT MEDICAL DEVICE CORRECTION. The letters advised customers of the issue and that a service representative would visit and inspect the therapy connector sockets, and replace the therapy connector and the mating cable if short drill sockets are found.

Device

Device Recall LIFEPAK 12
  • Model / Serial
    Domestic Serial Numbers: 34106383, 33996555, 33992033, 33992030, 33992029, 33992031, 33992027, 33990244, 33990241, 33990245, 33990242, 33990240, 34096406, 34086957, 34039438, 34100891, 33917921, 34100498, 34019560, 34011939, 34011940, 33985062, 33985063, 33985064, 33985065, 33985066, 33985067, 33985068, 33985070, 33985069, 33985074, 33985061, 33985071, 33985073, 33915256, 34016156, 34016153, 34016154, 34016155, 34016157, 34016158, 33989218, 33989220, 33989216, 33989219, 33989217, 34039448, 34048193, 34100900, 34020194, 34020192, 34060159, 33988136, 33988137, 34020193, 33995357, 33949669, 34074066, 33913884, 34014205, 11201950, 34091725, 34064561, 33913893, 33913894, 33913895, 34004873, 33995317, 33995318, 33995316, 33995315, 33995319, 34064439, 34064440, 34064441, 34020190, 34020507, 34020187, 34020189, 34020188, 34019563, 34019572, 34019573, 33904159, 33905092, 34095289, 34095297, 34095301, 33991999, 33992000, 33992003, 33992023, 33992028, 33992016, 33991998, 34087619, 34087620, 34087605, 34087610, 34087612, 34087035, 34087892, 34087602, 34087615, 34087616, 34087617, 34087618, 34086700, 34086709, 34086715, 34087613, 34086714, 34087609, 34087607, 34087614, 34087608, 34086718, 34086706, 34086719, 34086711, 34086713, 34086705, 34086717, 34086702, 34087606, 34086703, 34087033, 34086708, 34086712, 34087603, 34086707, 34087604, 34086716, 34087601, 34087034, 34091720, 33949930, 34091120, 34039430, 34039429, 34015786, 34011974, 33982989, 33899585, 33995356, 33995351, 33995350, 33995346, 33995360, 33995355, 33995369, 33995349, 33995348, 33995352, 33995347, 33995359, 33995353, 33995345, 33995358, 33995354, 12737672, 33913878, 34094631, 34049603, 34049601, 34049604, 34049611, 34049606, 34049607, 34049609, 34049612, 34049608, 34049610, 34049605, 34049602, 30859396, 33978921, 33978922, 33978923, 33978924, 34039468, 34039433, 34039470, 34083705, 34096379, 33915357, 33988150, 33992032, 33931367, 33931365, 33931364, 33931363, 33931362, 33931366, 34052702, 34052703, 33795379, 34095303, 34095298, 34095299, 34095304, 34095300, 34096375, 34095314, 34095313, 34095312, 34095307, 34095306, 34095305, 33862271, 34019587, 34020177, 34019586, 34019585, 34090338, 34090337, 34049130, 34043663, 34086675, 34086676, 34086671, 34086672, 34086674, 34086673, 33832318, 33888386, 33888372, 33888377, 33888376, 33888378, 33888379, 33888383, 33888385, 33888384, 33888373, 34044798, 34064654, 34019555, 34019554, 33802295, 33990042, 33982418, 33982417, 34074060, 34074061, 34095296, 34039463, 33950592, 33983052, 34099021, 34095323, 34082638, 34078647, 34078648, 34078646, 34082590, 34082591, 34048199, 34048200, 34049140, 34049141, 34048196, 34048198, 34045124, 34048194, 34010325, 33899587, 34096386, 34074089, 33974887, 33974888, 34078076, 34100491, 34100492, 34099179, 34099180, 34099178, 34099177, 34099176, 34090571, 34067899, 33995913, 33995914, 33974374, 33974373, 34013030, 34083205, 34019584, 10732394, 10732404, 34079488, 34084291, 34084290, 34004900, 34019558, 34019561, 33913867, 33913879, 33913888, 33995281, 33995280, 34090554, 34090556, 34090555, 34052280, 33991462, 34065273, 34048197, 34048195, 34034132, 34004904, 34082921, 34060126, 34060127, 34060128, 34086704, 34086701, 34086710, 33992506, 34074081, 34074073, 33855207, 33995302, 33995301, 34054626, 34054625, 33904163, 12776983, 33997196, 33987972, 33987973, 33928602, 34010320, 33974366, 34095302, 33938189, 34040207, 34039481, 34060174, 34060158, 34060161, 34060160, 34064667, 34003616, 34039469, 34060746, 34034134, 34106173, 33995035, 34074053, 34010323, 34090366, 34087611, 34090303, 34090302, 34091128, 34091129, 34095293, 33897593, 34078783, 34078784, 34078785, 34074072, 33992007, 33992020, 33993956, 33992022, 33992002, 33992021, 33992024, 33992025, 33992026, 33992004, 33992009, 33992015, 33992001, 33990248, 33992006, 33992005, 33992008, 33992014, 33992018, 33992017, 33990243, 33990246, 33990247, 33992011, 33992012, 33992013, 33992019, 33992010, 34019904, 33899702, 33960797, 33960796, 33960799, 33960798, 33960795, 33995049, 34061036, 34090589, 33931359, 33931358, 33931355, 33931356, 33931357, 34079490, 34079489, 34079833, 34079492, 34079491, 34079487, 34079486, 34079485, 33936114, 34068040, 34068041, 34078675, 33925842, 33925844, 33925846, 33925841, 33925843, 33925845, 33935283, 33935282, 33935281, 33935280, 33928109, 34090546, 34039464, 34082588, 33911101, 33911100, 33965863, 34074054, 34070493, 33997671, 33997672, 34078070, 34064659, 33996557, 33996553, 33996551, 33996550, 33996556, 33996549, 33996849, 33996558, 33996554, 33996552, 33993444, 34095321, 34095327, 34095331, 34095330, 34095326, 34095329, 34095320, 34095324, 34095328, 34095322, 33983339, 33976090, 33983346, 33983345, 33983338, 33983337, 33983336, 33983335, 32525390, 33995263, 34020191, 34019826, 34019557, 34019827, 34019556, 13583628, 34005592, 34005591, 34005587, 34005588, 34005589, 34005590, 33969580, 33969582, 33969581, 33969583, 33969584, 33995222, 34045762, 34099186, 34099185, 33991446, 33903858, 33997197, 34084471, 34075613, 34075614.    International Serial Numbers: 34098600, 34098601, 34090290, 34049509, 34049514, 34049515, 34083701, 34083702, 34044802, 33982442, 33982438, 33982439, 33934527, 33903205, 33903206, 33903208, 33903204, 33903198, 33903203, 33903207, 33903201, 33903210, 33903202, 33903199, 33903200, 33934528, 33934531, 33934529, 33934526, 33934530, 33928168, 33903217, 33928174, 33928165, 33982454, 33982437, 33982443, 33982440, 33903216, 33903215, 33982453, 33982452, 33982451, 33982450, 33982441, 33982448, 33982447, 33982446, 33982445, 33982444, 33982449, 33903209, 33928169, 33928160, 33928161, 33928162, 33928164, 33928170, 33928171, 33928172, 33928173, 33928175, 33928176, 33928177, 33928167, 33903211, 33903212, 33903213, 33903214, 33928159, 33950039, 33950038, 33950048, 33952773, 33952774, 33952775, 33952771, 34105152, 33950032, 33876945, 33876930, 33821315, 33876931, 34078216, 33876941, 33876943, 33876942, 33876938, 33876944, 33876952, 33876928, 33876946, 33876951, 33876950, 33876948, 33876940, 33876933, 33876935, 33876936, 33876937, 33950037, 33929937, 33950034, 33950043, 33950042, 33950041, 33950040, 33950053, 33950052, 33950051, 33950049, 33950045, 33950046, 33950047, 33950035, 33950050, 33950054, 33876949, 33876947, 33876939, 33876934, 33876932, 34079098, 33876929, 33950044, 33950033, 33950031, 33950030, 33950036, 34078082, 34078078, 34078081, 34078080, 34079097, 34083393, 34078079, 33985301, 33985300, 33985299, 33985307, 33986568, 33952772, 34079096, 34078215, 34078217, 34078225, 33982471, 33985298, 33985303, 33985304, 33986537, 33985302, 34009595, 34009594, 34009593, 34083729, 34083732, 34077752, 34106204, 34091376, 13669402, 33928605, 33985022, 33983183, 33979582, 33979583, 33974289, 33974293, 33952829, 33952830, 33798619, 33913915, 33798616, 33913909, 33918168, 33918735, 33918736, 33872713, 33918165, 33918166, 33918167, 33918181, 33795390, 33798614, 33896029, 33887441, 33798612, 33795399, 33795397, 33932561, 34094348, 34094349, 34091746, 33986283, 34039425, 33986294, 33983009, 33795389, 33983184, 33983178, 33983010, 33961531, 34074827, 34087714, 33974286, 34049521, 34049526, 34049527, 34049528, 34049529, 34049530, 34053704, 34049523, 33913897, 33913904, 34008743, 34008737, 34003664, 34003634, 34020680, 34020681, 34020164, 34020510, 34034118, 34034725, 33983556, 33974288, 33974287, 33979581, 33974290, 33974291, 34049522, 33983555, 33983554, 33979580, 33974229, 33974292, 33986320, 33913913, 34049520, 33986261, 33974295, 34053733, 34049525, 34053699, 34049524, 33913899, 33913900, 33913901, 33913902, 33985306, 33913905, 34069183, 33985305, 33913898, 33913903, 33913906, 33986313, 33986285, 34003817, 34049519, 34003650, 34003796, 34004911, 34008686, 34008744, 34008742, 34008740, 34008739, 34008738, 34008687, 34008745, 34008741, 34003658, 34020516, 34084458, 34084468, 34074427, 34084092, 34087711, 34087496, 33937399, 33937400, 33937398, 34090742, 33937401, 33937404, 34074835, 33937402, 34083715, 33937403, 33937397, 34090743, 33937405, 33910410, 33910411, 34090741, 34083714, 34044811, 34044812, 34039416, 34074102, 33979590, 34074107, 33983550, 34039419, 34073371, 34039413, 33958404, 33958774, 34074106, 33855054, 33921591, 33921592, 33880013, 33880012, 33880011, 33895654, 33900603, 33899646, 33895655, 33961098, 33961097, 33978886, 34074101, 34106223, 33973952, 33978885, 33979004, 33978888, 33978887, 33983551, 34039415, 34039409, 34039408, 33979564, 33979567, 34079036, 33895653, 33895652, 33895651, 33895650, 33895649, 33893664, 33892562, 33945926, 34074108, 34064246, 34039418, 33895656, 34064247, 34074105, 33968953, 34074099, 34074595, 34074596, 34074104, 34074098, 33949217, 33968972, 33969016, 34074103, 34008392, 34039421, 34012451, 34039422, 34040777, 34040525, 33969015, 34039406, 33968973, 34039405, 33968970, 33968962, 33968966, 33968964, 33969014, 34039407, 33968968, 34034122, 34034124, 34034127, 34034129, 34073370, 33983559, 34073365, 34073366, 34073376, 34065724, 34073364, 33905086, 33905087, 33905088, 33905089, 34003929, 34073369, 34073372, 34073373, 34073374, 34073375, 33968961, 33968963, 33983561, 34079035, 34043644, 34079040, 34079039, 34079037, 34073368, 34073367, 34073363, 34079038, 33928097, 34039410, 34043602, 33983560, 34039411, 34039412, 34043601, 34039414, 33928392, 33968957, 33968956, 33968955, 33968954, 34004876, 34043599, 34044807, 34004928, 34004927, 33968971, 34039417, 34003928, 34004922, 34004924, 34039423, 33968959, 34106425, 34106224, 34106225, 34086724, 34091392, 34086725.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics,
  • Product Description
    LIFEPAK 12 defibrillator/monitor
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.

Manufacturer

Medtronic Emergency Response Systems, Inc.
  • Manufacturer Address
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA