FDA-Device2022-08-17Class I
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Sold states
Worldwide Distribution
Affected count
866 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2022Don't want to check this manually?
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