ANZCDACC Implant Hazard Alert June 2021
Device: Boston Scientific dual chamber INGENIO family pacemakers and Cardiac resynchronisation (CRTPs).
Models: ADVANTIO DR EL (K084, K087), INGENIO DR EL (K184, K187), VITALIO DR EL (K287), INVIVE CRT-P (V182, V183)
TGA Reference: RC-2021-RN-01305-1
Australian Register of Therapeutic Goods (ARTG): 194925, 194926, 194927, 202980, 202981, 202982, 213922, 213923, 213924, 213925, 213926, 213927, 194920, 194921, 194924, 202999, 203000, 203004, 213930, 213931, 194928 and 194929
Advisory grade TGA: Class I
(Class I recall action occurs when the product deficiency is potentially life-threatening or could cause a serious risk of health).
ANZDACC Advisory Grade: Semi-urgent