Device Recall Cardiosave

All Serial Numbers distributed from 03/06/2012 to 04/26/2018

Cardiovascular Devices

2

No

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.

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

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

Cardiovascular Devices

2

No

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

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.