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
- Ovation Abdominal Stent Graft System
- Ovation Prime Abdominal Stent Graft System
- 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