FDA-Device2018-01-24Class II
ACCOLADE MRI EL DR Pacemaker
Boston Scientific Corporation
Hazard
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Sold states
AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide
Affected count
N/A
Manufactured in
4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, United States
Products
ACCOLADE MRI EL DR Pacemaker
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0359-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief