NRAC Issue #1580 ADDENDUM May 31, 2006 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- PRODUCT a) CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies RECALL NUMBER # Z-0890-06; PRODUCT b) CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies RECALL NUMBER # Z-0891-06; PRODUCT c) VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator) RECALL NUMBER # Z-0892-06 CODE a) Model H170, serial numbers: 360449, 360632, 360655, 360657, 360661, 360666, 360714, 360719, 360721, 360738, 360741, 360742, 360743, 360745, 360746, 360749, 360756, 360758, 360763, 360766, 360790, 360791, 360792, 360796, 360800, 360802, 360844, 360847, 360848, 360861, 360863, 360904, 360907, 360908, 360910, 360986, 360987, 360988, 360989, 360991. Model H175 serial numbers: 310338, 310434, 310523, 310532, 310533, 310537, 310544, 310545, 310706, 310707, 310709, 310713, 310719, 310721, 310734, 310735, 310737, 310746, 310753, 310796, 310798, 310813, 310907, 310908, 310909, 310913, 310916, 310976, 310990, 310996, 311007, 311010, 311011, 311013, 311015, 311016, 311092, 311096, 311152, 311154, 311181, 311185, 311386, 311389. Model H177, serial numbers: 280992, 281011, 281012, 281017, 281020, 281021, 281022, 281024, 281045, 281056, 281066, 28107, 281077, 281119, 281121, 281123, 281124, 281126, 281127, 281143, 281175, 281213, 281233, 281247, 281320, 281356, 281364, 281368, 281371, 281376, 281385, 281401, 281403, 281413, 281476, 281480, 281484, 281485, 281491, 281533, 281539, 281542, 281544, 281559, 281562, 281580. Model H179, serial numbers: 110905, 110907, 110908, 110950, 110952, 110954, 110955, 110958, 110980, 110983, 110987, 110988, 111000, 111001, 111003, 111004, 111007, 111012, 111024, 111041, 111042, 111128, 111173, 111180, 111198, 111201, 111248, 111250, 111254, 111263, 111294, 111299, 111308, 111313, 111334, 111335, 111336, 111338, 111340, 111341, 111342, 111346, 111350, 111352, 111390, 111391, 111392, 111393, 111397, 111422; b) Model H190, serial numbers: 310258, 310260, 310293, 310312, 310317, 310319, 310320, 310321, 310322, 310343, 310353, 310355, 310381, 310383, 310386, 310387, 310388, 310389, 310390. Model H195, serial numbers: 350236, 350239, 350245, 350247, 350248, 350250, 350252, 350255, 350261, 350264, 350276, 350279, 350280, 350282, 350284, 350319, 350330, 350331, 350332, 350333, 350334, 350336, 350342, 350344, 350350, 350351, 350353, 350354, 350355, 350360, 350362, 350363, 350364, 350365, 350403, 350407, 350442, 350451, 350480, 350484, 350503, 350570, 350649. Model H199, serial numbers: 320330, 320331, 320361, 320366, 320370, 320415, 320417, 320445; c) Model T125, serial numbers: 115233, 115234, 115237, 115239, 115240, 115241, 115335, 115370, 115399, 115400, 115479. Model T165, serial numbers: 110803, 110806, 110830, 110833, 110835, 110836, 111081, 111270, 111271, 111273, 111274, 111299, 111329, 111332, 111333, 111337, 111339, 111442, 111493, 111611, 111687, 111842, 111844, 111886, 111979, 112029, 112174, 112175. Model T175, serial number 109787 MANUFACTURER Guidant-Ireland, Clomel, Ireland. RECALLED BY Guidant Corporation, Saint Paul, MN, QUANTITY 290 units DISTRIBUTION Nationwide and Internationally REASON Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier. --------------------------------------------------------------------------- 1