TriVascular Ovation Prime Abdominal Stent Graft System Instructions for Use Update
TriVascular, Inc. is notifying European physician users of the Ovation Prime Abdominal Stent Graft System about changes to the Instructions for Use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states it is a communication regarding changes to Instructions for Use with no reported injuries or illnesses, fitting the criteria for documentation issues or low-risk administrative updates.
Plain-English summary
TriVascular, Inc. is issuing a communication to European physician users regarding the Ovation Prime Abdominal Stent Graft System. This action involves notifying users of changes to the Instructions for Use (IFU) for the device.
The Ovation Prime Abdominal Stent Graft System is an endovascular device designed to treat abdominal aortic aneurysms (AAAs). It is delivered via a small diameter catheter and is configured with an aortic body section, iliac limbs, and iliac extensions. The device is intended to reline diseased vasculature to isolate the aneurysm from high-pressure blood flow.
The distribution of the affected units includes Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden. The source text does not specify a specific reason for the IFU changes, nor does it report any injuries, illnesses, or deaths associated with the device.
The recalled product
- Product
- Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurys
- Manufacturer
- Trivascular, Inc
- Hazard
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All codes
Distribution
Distribution scope not specified by the agency.
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