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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 1/5 (Low).
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…
- 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.
Related recalls
Same manufacturer · Trivascular, Inc
See all →- SevereTriVascular Recalls Ovation Prime Abdominal Stent Grafts Due to Injection Issue
FDA (Devices) · 2014-11-12
- HighTrivascular Recalls Fill Polymer Kits Due to Potential Stopcock Leaks
FDA (Devices) · 2012-11-21
Same hazard · documentation issue
See all →- LowHeartSine Defibrillators Recalled for Missing Maintenance Supplement
FDA (Devices) · 2026-10-07
- SevereBMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
FDA (Devices) · 2026-08-26
- LowFARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
FDA (Devices) · 2026-07-29
- ModerateFARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
FDA (Devices) · 2026-07-29
- LowPenner bathing spa models recalled for lacking a unique device identifier
FDA (Devices) · 2026-03-18
Similar recalls
- SevereTriVascular Recalls Ovation Prime Abdominal Stent Grafts Due to Injection Issue
FDA (Devices) · 2014-11-12
- ModerateEndologix AFX Endovascular AAA System Instructions for Use Update
FDA (Devices) · 2017-01-25
- ModerateEndologix AFX Endovascular AAA System Instructions for Use Updated
FDA (Devices) · 2017-01-25
- ModerateEndologix Updates Instructions for Use for AFX Endovascular AAA System
FDA (Devices) · 2017-01-25
- HighTrivascular Recalls Fill Polymer Kits Due to Potential Stopcock Leaks
FDA (Devices) · 2012-11-21
- HighTREO Abdominal Stent-Graft Label Does Not Match Actual Device Size
FDA (Devices) · 2023-06-14