Devices

Vitality DR HE

Fabricant

Boston Scientific GmbH
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    SATP

Un dispositif médical avec un nom similaire

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Device Recall VITALITY DR HE
  • Modèle / numéro de série
    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, 201947, 201948, 201949, 201950, 201951, 201952, 201953, 201954, 201955, 201956, 201957, 201958, 201959, 201960, 201961, 201962, 201963, 201964, 201965, 201966, 201967, 201968, 201969, 201970, 201971, 201973, 201974, 201975, 201976, 201977, 201978, 201979, 201980, 201981, 201982, 201983, 201984, 201985, 201988, 201990, 201991, 201992, 201993, 201994, 201995, 201997, 201998, 201999, 202000, 202001, 202002, 202003, 202004, 202005, 202006, 202007, 202008, 202009, 202010, 202012, 202013, 202014, 202015, 202017, 202018, 202019, 202020, 202021, 202022, 202023, 202024, 202025, 202026, 202028, 202029, 202031, 202032, 202033, 202034, 202036, 202037, 202038, 202039, 202041, 202042, 202043, 202044, 202045, 202046, 202047, 202048, 202049, 202050, 202051, 202052, 202053, 202054, 202055, 202056, 202057, 202058, 202059, 202060, 202061, 202062, 202063, 202066, 202068, 202069, 202070, 202071, 202072, 202073, 202074, 202075, 202076, 202077, 202078, 202079, 202080, 202081, 202082, 202083, 202085, 202086, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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).
  • Manufacturer
    Boston Scientific CRM Corp