FDA-Device2022-06-22Class II
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Sold states
Distributed nationwide to 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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and internationally to Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Canary Islands, Chile, Croatia, Czech Republic, Denmark, Egypt, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Greece, Greenland, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kuwait, Liechtenstein, Luxembourg, Malaysia, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom, United States, Uruguay, Australia , Korea, Panama, South Korea
Affected count
3944 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2022Don't want to check this manually?
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