International safety notice

Miller Balloon (model 830515F) and Fogarty Dilation (model 830705F) Atrioseptostomy Catheters

Ireland / HPRA · IRL · May 1, 2019

Key facts

Title Miller Balloon (model 830515F) and Fogarty Dilation (model 830705F) Atrioseptostomy Catheters
Regulator Ireland / HPRA
Country IRL
Brand Miller Balloon (model 830515F) and Fogarty Dilation (model 830705F) Atrioseptostomy Catheters
Manufacturer Edwards Lifesciences
Models 830515F, 763-514-4000, 830705F, 315-328-4491
Event type Recall
Date May 1, 2019
Regulator page hpra.ie

At a glance

  • Yes Recall
  • No 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

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