Health product recall

Ovation iX Abdominal Stent Graft System Platform (2020-05-07)

Starting date:
May 7, 2020
Posting date:
May 15, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73123

Last updated: 2020-05-15

Affected Products

Ovation iX Abdominal Stent Graft System Platform

Reason

This is a follow-up to the advisory notice of 30 August 2018 and reaffirms treatment recommendations for patients who experience a polymer leak during implantation, provides updated information on the current rate of polymer leaks, the rate of clinical harms and root cause

Affected products

Ovation iX Abdominal Stent Graft System Platform

Lot or serial number
  • All lots.
Model or catalog number
  • TV-AB2080-J
  • TV-AB2380-J
  • TV-AB2680-J
  • TV-AB2980-J
  • TV-AB3480-J
Companies
Manufacturer

Trivascular Inc.,

3910 Brick way Blvd.,

Santa Rosa,

95403

California

UNITED STATES