Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3

Recalled June 22, 2022 · FDA recall Z-1268-2022 · 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). · FDA Class II

Units

3944 units

Sold at

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

Description

Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

Product

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

Manufacturer(s)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →