BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Urgent Safety Notice for the NeoChord DS1000 device, NeoChord Inc.

Product group Non-active implants - cardiac surgery
Reference 01883/14

The manufacturer NeoChord Inc. has informed his customers about an expansion of his instructions for use of the product NeoChord DS1000.
Reason for this measure were two incidents in which the patients have had native anterior leaflet chordae of the mitral valve cut as a result of the implanted neochords interfering with the native chordae.

For further information as well as details concerning the device please see the enclosed Advisory Notice of the manufacturer.

Urgent Safety Notice for the NeoChord DS1000 device, NeoChord Inc. , Download_VeroeffentlichtAm_EN PDF, 103KB, File does not meet accessibility standards