Health product recall

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

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

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System

Lot or serial number

All lots.

Model or catalog number

9630TF20
9630TF23
9630TF26
9630TF29

Companies
Manufacturer

Edwards Lifesciences LLC

1 Edwards Way

Irvine

92614

California

UNITED STATES