International safety notice

INGENIO™, VITALIO™, and ADVANTIO™ pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps)

Ireland / HPRA · IRL · Jul 1, 2021

Key facts

Title INGENIO™, VITALIO™, and ADVANTIO™ pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps)
Regulator Ireland / HPRA
Country IRL
Brand INGENIO™, VITALIO™, and ADVANTIO™ pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps)
Manufacturer Cardiac Pacemaker Inc./Boston Scientific
Models 00802526525384, 00802526566301, 00802526543654, 00802526539824, 00802526559051, 00802526578007, 00802526559457, 00802526566660, 00802526540240, 00802526559167, 00802526539404, 00802526578052 and 352 more
Event type Safety Notice
Date Jul 1, 2021
Regulator page hpra.ie

At a glance

  • No Recall
  • Yes Field safety notice
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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