Device Recall VITALITY DR HE

Model T180, serial numbers: 200020, 200025, 200029, 200059, 200063, 200065, 200068, 200088, 200109, 200111, 200210, 200237, 200358, 200360, 200362, 200440, 200443, 200480, 200581, 200584, 200627, 200663, 200700, 200717, 200725, 200727, 200730, 200743, 200774, 200801, 200847, 200863, 200868, 200884, 200916, 200918, 200962, 200979, 201013, 201026, 201064, 201077, 201082, 201108, 201115, 201124, 201138, 201149, 201151, 201166, 201171, 201182, 201186, 201222, 201224, 201227, 201243, 201263, 201281, 201283, 201287, 201290, 201297, 201298, 201308, 201332, 201388, 201393, 201396, 201451, 201479, 201481, 201524, 201530, 201539, 201548, 201550, 201582, 201589, 201592, 201617, 201629, 201634, 201649, 201685, 201700, 201701, 201702, 201704, 201731, 201732, 201759, 201763, 201768, 201838, 201841, 201861, 201872, 201874, 201891, 201901, 201905, 201908, 201909, 201927, 201929, 201930, 201931, 201933, 201934, 201936, 201937, 201938, 201939, 201940, 201941, 201942, 201943, 201944, 201945, 201946, 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201871, 201875, 201876, 201877, 201878, 201879, 201880, 201881, 201882, 201883, 201884, 201886, 201887, 201888, 201889, 201890, 201892, 201894, 201895, 201897, 201898, 201899, 201900, 201903, 201904, 201906, 201907, 201910, 201912, 201913, 201914, 201915, 201916, 201917, 201918, 201920, 201921, 201922, 201923, 201924, 201925, 201926, 202403, 202545, 204685.

Cardiovascular Devices

3

Yes

Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.

VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-eneergy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing).