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Abdominal Stent Graft System-Ovation Prime (2014-09-19)
- Starting date:
- September 19, 2014
- Posting date:
- October 2, 2014
- 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-41631
Recalled Products
Abdominal Stent Graft System-Ovation Prime
Reason
Rapid emptying of the fill polymer syringe when it is connected to the auto injector during the fill polymer injection step of the primary implant procedure has resulted in incomplete aortic body graft fill, transient hypotension response, prolonged procedure time, and/or failure to exclude the aneurysm.
Affected products
Abdominal Stent Graft System-Ovation Prime
Lot or serial number
FS031814-11
Model or catalog number
TV-AB2980-D
Companies
- Manufacturer
-
Trivascular Inc.,
3910 Brick way Blvd.,
Santa Rosa,
95403
California
UNITED STATES