Health product recall

Ovation, Ovation Prime, and Ovation IX Abdominal Stent Graft System (2018-08-30)

Starting date:
August 30, 2018
Posting date:
September 7, 2018
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-67712

Affected products

  1. Ovation Abdominal Stent Graft System
  2. Ovation Prime Abdominal Stent Graft System
  3. Ovation IX Abdominal Stent Graft System

Reason

To report the ovation safety notice update as an advisory notification to users of potential intra-vascular polymer leaks when following the steps in the Instructions for Use (IFU) out of sequence, and to emphasize the current warnings and cautions in the IFU to further mitigate these potential events.

Affected products

A. Ovation Abdominal Stent Graft System

Lot or serial number

All lots, contact manufacturer.

Model or catalog number
  • TV-AB2080-B
  • TV-AB2380-B
  • TV-AB2680-B
  • TV-AB2980-B
  • TV-AB3480-B
Companies
Manufacturer

Trivascular Inc.,

3910 Brick way Blvd.,

Santa Rosa,

95403

California

UNITED STATES


B. Ovation Prime Abdominal Stent Graft System

Lot or serial number

All lots, contact manufacturer.

Model or catalog number
  • TV-AB2080-D
  • TV-AB2380-D
  • TV-AB2680-D
  • TV-AB2980-D
  • TV-AB3480-D
Companies
Manufacturer

Trivascular Inc.,

3910 Brick way Blvd.,

Santa Rosa,

95403

California

UNITED STATES


C. Ovation IX Abdominal Stent Graft System

Lot or serial number

All lots, contact manufacturer.

Model or catalog number
  • TV-AB2080-I OR J
  • TV-AB2380-I OR J
  • TV-AB2680-I OR J
  • TV-AB2980-I OR J
  • TV-AB3480-I OR J
Companies
Manufacturer

Trivascular Inc.,

3910 Brick way Blvd.,

Santa Rosa,

95403

California

UNITED STATES