Devices

Device Recall Cardiosave

  • Model / Serial
    part number 0146-00-0097
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX || Li-Ion Battery affected part number is 0146-00-0097 || Product Usage: || The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
  • Manufacturer
    Maquet Datascope Corp - Cardiac Assist Division
  • 1 Event

Manufacturer

Maquet Datascope Corp - Cardiac Assist Division
  • Manufacturer Address
    Maquet Datascope Corp - Cardiac Assist Division, 1300 Macarthur Blvd, Mahwah NJ 07430-2052
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall CARDIOSAVE Hybrid Intraaortic Balloon Pump (IABP)
  • Model / Serial
    All Serial Numbers distributed from 03/06/2012 to 04/26/2018
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The devices were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Guam. The devices were distributed to the following foreign countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrica, Taiwan, Thailand, Turkey, UAE, UK, Vietnam, Yemen.
  • Product Description
    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
  • Manufacturer
    Maquet Datascope Corp - Cardiac Assist Division
Device Recall CARDIOSAVE IntraAortic Balloon Pump
  • Model / Serial
    510K K112372 Device Listing Number D132687   US Customer IABPs CA202159K1 CA202167K1 CA203492L1 CA203494L1  International Customer IABPs CA203486L1 CA202155K1 CA202161K1 CA203487L1 CA203490L1 CA203507L1 CA204330L1 CA204328L1 CA203505L1  International Company Owned IABPs  CA204327L1 CA202150K1 CA203506L1 CA204324L1 CA204326L1 CA202163K1 CA202169K! CA203497L1 CA203498L1 CA203496L1 CA203503L1 CA203488L1 CA203493L1 CA203508L1 CA204337L1 CA203502L1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including ID and Fl and Internationally to United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, Spain, Sweden, and Thailand
  • Product Description
    CARDIOSAVE Intra-Aortic Balloon Pump || An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
  • Manufacturer
    Maquet Cardiovascular, LLC