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
Check against the official notice below — it lists the full affected range.
Medtronic Inc. is recalling approximately 3,944 units of Crome and Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) loaded with CareLink SmartSync Device Manager application software. The devices are subject to a telemetry error that may occur during operation. The recalled devices were distributed nationwide across all U.S. states and internationally to multiple countries including Canada, Australia, and various European nations.
The specific affected models include Crome VR (models DVPC3D1 and DVPC3D4) and Crome DR devices, identified by their serial numbers listed in the recall documentation. The source document does not specify what remedy or corrective action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Reason for recall: Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Distribution: 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, Finla Quantity: 3944 units Lot/code info: a) Crome VR: DVPC3D1, DVPC3D4; Model DVPC3D1: GTIN 00763000178536, Serial Numbers: RSG600215S, RSG600212S, RSG600196S, RSG600280S, RSG600223S, RSG600208S, RSG600106S, RSG600094S, RSG600125S, RSG600193S, RSG600006S, RSG600123S, RSG600016S, RSG600136S, RSG600249S, RSG600113S, RSG600395S, RSG600173S, RSG600118S, RSG600116S, RSG600112S, RSG600130S, RSG600111S, RSG600191S, RSG600205S, RSG600143S, RSG600175S, RSG600209S, RSG600272S, RSG600167S, RSG600187S, RSG600077S, RSG600162S, RSG600253S, RSG600245S, RSG600131S, RSG600145S, RSG600237S, RSG600107S, RSG600220S, RSG600037S, RSG600119S, RSG600144S, RSG600231S, RSG600163S, RSG600185S, RSG600210S, RSG600148S, RSG600171S, RSG600157S, RSG600172S, RSG600137S, RSG600201S, RSG600190S, RSG600114S, RSG600247S, RSG600183S, RSG600278S, RSG600243S, RSG600246S, RSG600166S, RSG600152S, RSG600228S, RSG600204S, RSG600242S, RSG600126S, RSG600141S, RSG600138S, RSG600174S, RSG600122S, RSG600200S, RSG600225S, RSG600232S, RSG600140S, RSG600233S, RSG600086S, RSG600083S, RSG600250S, RSG600178S, RSG600134S, RSG600168S, RSG600117S, RSG600110S, RSG600115S, RSG600109S, RSG600255S, RSG600108S, RSG600164S, RSG600159S, RSG600158S, RSG600219S, RSG600181S, RSG600132S, RSG600240S, RSG600186S, RSG600121S, RSG600179S, RSG600055S; GTIN 00763000178543, Serial Numbers: RSG600313S, RSG600079S, RSG600306S, RSG600105S, RSG600103S, RSG600317S, RSG600379S, RSG600330S, RSG600063S, RSG600315S, RSG600316S, RSG600335S, RSG600334S, RSG600333S, RSG600332S, RSG600311S, RSG600444S,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.