Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-08…

Recall date

May 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1928-2018

FDA classification

Class I

Brand / firm

Maquet Datascope Corp - Cardiac Assist Division

Sold / distributed

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…

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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