Device Recall HeartMate

  • 모델명 / 제조번호(시리얼번호)
    All Codes
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Product was released for distribution to 117 direct accounts nationwide and to 31 foreign accounts including 2 Canadian accounts. [Canadian Consignee #1]: Transplant Surgeon, Dr. Renzo Cecere, MD FRCS(C), Hospital Royal Victoria, Chirurgle Cardio-Thoracique, 687 Ave Des Pins Ouest, Montreal, Quebec, H3A 1A1, Canada [Canadian Consignee # 2]: Transplant Surgeon Dr. Christopher M. Feindel MD FRCS(C), Toronto General Hospital, Division of Cardiothoracic Surgery, Toronto, Ontario, M5G 2CA, Canada.
  • 제품 설명
    HeartMate Stroke Volume Limiter (SVL) || Catalog # 1295
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 7 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    All Serial numbers.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
  • 제품 설명
    HeartMate¿ II LVAS with Pocket Controller; || 107801 - HMII PUMP & POCKET CTRL ONLY || UDI:00813024011286 || Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers PC-14810, PC-14828, PC-14843, PC-14846, and PC-14848.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
  • 제품 설명
    HeartMate¿ II LVAS with Pocket Controller; || 106015 - HMII LVAD SEALED KIT-PCTRL, NA || UDI: 00813024011224 || Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
  • 제품 설명
    HeartMate¿ II LVAS with Pocket Controller; || 106762 - HMII POCKET CONTROLLER, NA; || UDI: 00813024011286 || Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Sealed Outflow Graft: Catalog number 103393, all lot numbers; Sealed Outflow Short Bend Relief; Catalog number 104692, all lot numbers; Catalog number 104911, HM II LVAS Implant Kit (with sealed grafts) [US labeling] (contains catalog number 103393); all serial numbers; Catalog number 104912, HM II LVAS Implant Kit (with sealed grafts) [CE Mark labeling], contains catalog no. 103393); all serial numbers:
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Denmark, Germany, Greece, France, Hong Kong, Kuwait, Ireland, Israel, Italy, Lebanon, Liechtenstein, Lithuania, Luxembourg, Malaysia, Netherlands, Turkey, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand and United Kingdom.
  • 제품 설명
    HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. || The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft, which in turn is a component of the HM II LVAS Implant Kit with Sealed Grafts. A short configuration of the HM II LVAS Sealed Outflow Graft Bend Relief is provided as a stand-along product. || Thoratec Corporation || 6035 Stoneridge Drive || Pleasanton, CA 94588. || Product Usage: || The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to Cardiac Transplanation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital. The outflow of the HM II LVAS blood pump is connected to the aorta with a flexible vascular graft. The outflow graft is provided with a bend relief, a three or four in long tube of reinforced ePTFE surrounding the outflow graft proximal to the pump that is designed to prevent kinking of the outflow graft.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog number 106762 (NAm) 106017 - EU all serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.
  • 제품 설명
    HeartMate II System Controller || Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.
  • Manufacturer
하나 더 2 건 더