medical Class I Updated 2018-06-06

Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Num

Recalled Product

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

Hazard / Issue

Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.

Issued by

FDA

Affected 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

Lot/Code Info: All Serial Numbers distributed from 03/06/2012 to 04/26/2018

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