Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt HF: DTPB2D4, DTPB2D1; g) Cobalt
Check against the official notice below — it lists the full affected range.
Medtronic Inc. is recalling approximately 51,922 units of Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) loaded with CareLink SmartSync Device Manager application software. The devices are affected by a telemetry error that may occur during operation. The recalled models include Cobalt XT VR (models DVPA2D1 and DVPA2D4) and Cobalt VR (model DVPB), identified by specific serial numbers listed in the recall notice.
The affected devices were distributed nationwide across all U.S. states and territories, as well as internationally to multiple countries including Canada, Australia, and various European nations. The record does not specify a remedy or recommended action for consumers.
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: 51922 units Lot/code info: a) Cobalt XT VR: DVPA2D1, DVPA2D4: Model DVPA2D1: GTIN 00763000178451, Serial Numbers: RSC600175S, RSC600169S, RSC600211S, RSC600163S, RSC600177S, RSC600212S, RSC600237S, RSC600217S, RSC601072S, RSC601241S, RSC601396S, RSC600327S, RSC600018S, RSC600347S, RSC600391S, RSC600419S, RSC601490S, RSC600423S, RSC600501S, RSC600337S, RSC600422S, RSC600420S, RSC600421S, RSC601410S, RSC601433S, RSC600281S, RSC600298S, RSC600131S, RSC601388S, RSC600174S, RSC600331S, RSC600240S, RSC600225S, RSC600299S, RSC600328S, RSC600293S, RSC601071S, RSC601345S, RSC601443S, RSC601450S, RSC601419S, RSC600417S, RSC600147S, RSC600275S, RSC601486S, RSC601313S, RSC601317S, RSC601542S, RSC601500S, RSC601520S, RSC600443S, RSC601244S, RSC601107S, RSC601515S, RSC601506S, RSC601231S, RSC601230S, RSC601229S, RSC601228S, RSC601227S, RSC601223S, RSC601222S, RSC601221S, RSC601216S, RSC601175S, RSC601422S, RSC601368S, RSC601366S, RSC601183S, RSC601106S, RSC601022S, RSC601510S, RSC601459S, RSC601554S, RSC601551S, RSC601547S, RSC601545S, RSC601543S, RSC601541S, RSC601538S, RSC601553S, RSC601552S, RSC601539S, RSC601358S, RSC601537S, RSC601534S, RSC601065S, RSC601532S, RSC601467S, RSC601028S, RSC601516S, RSC601214S, RSC601377S, RSC601378S, RSC601318S, RSC600224S, RSC601376S, RSC601226S, RSC601242S, RSC601126S, RSC601438S, RSC601184S, RSC601339S, RSC601491S, RSC601193S, RSC601365S, RSC601402S, RSC601415S, RSC601346S, RSC601100S, RSC601493S, RSC601441S, RSC600283S, RSC601420S, RSC601210S, RSC601217S, RSC600357S, RSC600319
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.