International safety notice

Edwards Lifesciences

United Kingdom / MHRA · GBR · May 7, 2019

Key facts

Title Edwards Lifesciences
Regulator United Kingdom / MHRA
Country GBR
Brand - 830705F - Catheter, Fogarty® Dilation Atrioseptostomy Catheter 5FR 50 cm ster. F/nat. rub. Latex. - 830515F - Catheter, Miller Balloon 5FR 50 cm Atrioseptostomy W/nat. rub. LatexFogarty® Dilation Atrioseptostomy Catheter.
Manufacturer Edwards Lifesciences
Models 830705F, 315-328-4491, 830515F, 763-514-4000
Event type Recall, Safety Notice
Action type Field safety notice
Date May 7, 2019
Regulator page gov.uk

At a glance

  • Yes 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