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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of…"
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.
Related recalls
Same manufacturer · Trivascular, Inc
See all →- LowTriVascular Ovation Prime Abdominal Stent Graft System Instructions for Use Update
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Similar recalls
- LowTriVascular Ovation Prime Abdominal Stent Graft System Instructions for Use Update
FDA (Devices) · 2014-04-02
- HighTrivascular Recalls Fill Polymer Kits Due to Potential Stopcock Leaks
FDA (Devices) · 2012-11-21
- SevereEndologix Ovation iX Abdominal Stent Graft Systems Recalled for Polymer Leak Risk
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