Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (2019-07-04)

Starting date:

July 4, 2019

Posting date:

July 16, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70433

Last updated: 2019-07-16

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  Reason
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  Affected products

Affected Products

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System

Reason

Edwards has received reports of burst balloons which have resulted in significant difficulty retrieving the SAPIEN 3 ultra delivery system into the sheath and withdrawing the system from the patient.

Affected products