Device Recall CONTAK RENEWAL 4 AVT

  • Model / Serial
    Model M170, serial numbers: 100136, 100138, 100142, 100144, 100145, 200003, 200004, 200006, 200007, 200009, 200010, 200011, 200013, 200017, 200018, 200019, 200021, 200022, 200023, 200025, 200027, 200028, 200029, 200030, 200032, 200033, 200034, 200035, 200036, 200037, 200038, 200039, 200041, 200042, 200043, 200046, 200047, 200048, 200051, 200052, 200053, 200054, 200056, 200057, 200058, 200059, 200060, 200073, 200074, 200077, 200079, 200082, 200084, 200087, 200088, 200089, 200090, 200093, 200094, 200095, 200098, 200101, 200112.  Model M175, serial numbers: 100202, 100207, 100209, 100210, 100211, 100212, 100213, 100214, 100215, 100216, 100219, 100221, 100222, 100224, 100251, 100277, 100282, 100283, 100284, 100298, 100299, 100336, 100341, 100344, 100345, 100349, 100350, 100353, 100354, 100356, 100358, 100361, 100362, 100369, 100370, 100372, 100384, 100401, 100404, 100407, 100409, 100410, 100411, 100418, 100421, 100433, 200002, 200003, 200004, 200005, 200007, 200009, 200010, 200011, 200012, 200014, 200015, 200016, 200017, 200019, 200022, 200025, 200027, 200028, 200029, 200030, 200032, 200033, 200034, 200036, 200038, 200039, 200040, 200042, 200044, 200047, 200048, 200051, 200052, 200053, 200054, 200056, 200057, 200058, 200060, 200062, 200067, 200071, 200074, 200075, 200079, 200080, 200081, 200083, 200084, 200085, 200086, 200088, 200089, 200091, 200092, 200093, 200094, 200095, 200108, 200112, 200113, 200115, 200124, 200143, 200153, 200156, 200157, 200158, 200162, 200163, 200166.  Model M177, serial numbers: 100154, 100157, 100158, 100168, 100169, 100173, 100174, 100180, 100181, 100182, 100183, 100190, 100191, 100196, 100197, 100221, 200003, 200004, 200005, 200006, 200007, 200008, 200009, 200010, 200011, 200012, 200013, 200014, 200015, 200016, 200017, 200018, 200020, 200021, 200022, 200023, 200024, 200025, 200026, 200027, 200028, 200029, 200030, 200032, 200033, 200034, 200035, 200036, 200037, 200038, 200039, 200040, 200041, 200042, 200044, 200045, 200046, 200047, 200048, 200049, 200052, 200053, 200054, 200055, 200056, 200057, 200058, 200059, 200060, 200062, 200066, 200067, 200068, 200069, 200072, 200073, 200074, 200076, 200078, 200080, 200081, 200083, 200084, 200085, 200086, 200087, 200089, 200090, 200091, 200092, 200093, 200095, 200096, 200097, 200099, 200102, 200104, 200105, 200106, 200107, 200108, 200109, 200110, 200111, 200112, 200113, 200114, 200115, 200116, 200117, 200118, 200119, 200120, 200121, 200122, 200123, 200124, 200125, 200126, 200128, 200129, 200130, 200131, 200134, 200135, 200136, 200140, 200141, 200142, 200143, 200145, 200146, 200147, 200148, 200149, 200150, 200152, 200153, 200154, 200155, 200156, 200158, 200160, 200161, 200164, 200165, 200166, 200167, 200168, 200169, 200170, 200171, 200172, 200175, 200177, 200178, 200179, 200180, 200181, 200182.  Model M179, serial numbers: 100216, 100217, 100219, 100223, 100227, 100228, 100229, 100230, 100231, 100232, 100233, 100235, 100237, 100238, 100239, 100240, 100243, 100244, 100247, 100250, 100253, 100256, 100257, 100263, 100266, 100270, 100271, 100272, 100274, 100275, 100276, 100278, 100279, 100280, 100281, 100282, 100283, 100285, 100287, 100290, 100291, 100293, 100294, 100295, 100297, 100298, 100300, 100302, 100303, 100304, 100305, 100315, 100316, 100317, 100319, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100338, 100342, 100343, 100349, 100353, 100354, 100391, 100430, 100435, 100436, 100437, 100439, 100440, 100441, 100442, 100448, 100449, 100450, 100452, 100467, 100469, 100470, 100473, 100475, 100479, 100480, 100482, 100488, 100489, 100500, 100502, 100503, 100515, 100516, 100517, 100520, 100522, 100533, 100543, 100545, 100547, 100549, 100552, 100555, 100556, 100557, 100558, 100563, 100566, 100567, 100568, 100577, 100579, 100581, 100584, 100587, 100589, 100590, 100591, 100614, 200002, 200003, 200004, 200005, 200006, 200007, 200008, 200009, 200010, 200013, 200014, 200015, 200016, 200017, 200018, 200019, 200020, 200021, 200022, 200023, 200024, 200026, 200027, 200028, 200029, 200030, 200031, 200032, 200035, 200036, 200037, 200039, 200040, 200042, 200043, 200044, 200046, 200047, 200049, 200051, 200052, 200053, 200054, 200055, 200056, 200058, 200059, 200060, 200061, 200062, 200063, 200064, 200065, 200066, 200068, 200070, 200071, 200072, 200075, 200077, 200078, 200079, 200080, 200081, 200083, 200084, 200086, 200088, 200089, 200090, 200092, 200093, 200094, 200096, 200097, 200100, 200101.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • 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
    These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170, M175, M177, M179). Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    all serial numers
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.
  • Product Description
    CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D (model no. M177 and M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, 4100 Hamiline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 4 AVT devices provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer