International safety notice

Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ cardiac resynchronization therapy pacemakers (CRT-P)

Ireland / HPRA · IRL · Jun 6, 2019

Key facts

Title Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ cardiac resynchronization therapy pacemakers (CRT-P)
Regulator Ireland / HPRA
Country IRL
Brand Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ cardiac resynchronization therapy pacemakers (CRT-P)
Manufacturer Medtronic Inc
Models IE9513488W, 0.000008, 0.027, 11400, FA871, 275799, 0.0028, 3090-3094
Event type Safety Notice
Date Jun 6, 2019
Regulator page hpra.ie

At a glance

  • No Recall
  • Yes Field safety notice
  • 1–9 Matching device models in FDA data
  • 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

Browse all International device safety notices