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VITALITY DR HE Implantable Cardioverter Defibrillator… recallZ-1054-2007 · Boston Scientific CRM Corp · initiated Mar 23, 2007

Terminated All recalls posted in July 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific CRM Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.

FDA root cause category: Other

What the company is doing

An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.

Recall details

Recall number
Z-1054-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 23, 2007
Posted by the FDA
Jul 11, 2007
Recalling firm
Boston Scientific CRM Corp
Quantity
3,041
Product code
NIK
FDA submissions
P010012
Distribution
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.

Product description

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).

Code information (models, lots, serial numbers)

Show the full code information (24k characters)

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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201235, 201236, 201237, 201238, 201239, 201240, 201241, 201242, 201244, 201246, 201247, 201248, 201249, 201250, 201251, 201252, 201253, 201254, 201255, 201257, 201258, 201260, 201261, 201264, 201265, 201266, 201267, 201269, 201270, 201273, 201274, 201275, 201276, 201277, 201278, 201279, 201282, 201284, 201285, 201286, 201289, 201291, 201292, 201293, 201294, 201295, 201296, 201299, 201300, 201301, 201302, 201303, 201304, 201305, 201306, 201307, 201309, 201310, 201313, 201314, 201317, 201318, 201319, 201320, 201321, 201322, 201324, 201325, 201326, 201327, 201328, 201329, 201330, 201331, 201335, 201337, 201338, 201340, 201341, 201342, 201343, 201345, 201346, 201347, 201350, 201351, 201352, 201353, 201354, 201355, 201356, 201357, 201358, 201359, 201360, 201361, 201362, 201363, 201364, 201365, 201366, 201367, 201368, 201369, 201370, 201371, 201372, 201373, 201374, 201375, 201377, 201378, 201379, 201380, 201381, 201382, 201383, 201384, 201385, 201387, 201389, 201390, 201391, 201394, 201395, 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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.

Other devices under the same FDA submission

50 devices cleared under P010012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 37769).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page