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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Cr
Recalled December 1, 2021 · FDA recall Z-0282-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
The processing of collected episode data may fail due to a software error. · FDA Class II
Units
18,715 devices
Sold at
Worldwide distribution - US Nationwide. There was military/government distribution. The countries of Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Liechtenstein, Luxembourg, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Description
The processing of collected episode data may fail due to a software error.
Product
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF; Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1. Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; 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 →