TriVascular Recalls Ovation Prime Abdominal Stent Grafts Due to Injection Issue
TriVascular is recalling specific lots of Ovation Prime Abdominal Stent Grafts because the fill polymer syringe may empty rapidly during the implant procedure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could impact the implant procedure, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TriVascular, Inc. is recalling select lots of Ovation Prime Abdominal Stent Graft System 29mm Aortic Body stent grafts. These are low-profile endovascular devices delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
The recall was initiated because the company identified that the fill polymer syringe may be associated with rapid emptying when connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.
The affected devices were labeled for distribution outside of the United States and were distributed internationally to Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus. The source text does not specify the total number of devices recalled or report any illnesses or injuries.
The recalled product
- Product
- Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
- Manufacturer
- Trivascular, Inc
- Hazard
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)
- therefore
Distribution
Distribution scope not specified by the agency.
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