Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TriVascular brand Fill Polymer Kit Recalled by Trivascular, Inc Due to Selected lots of the Fill Polymer Kit (European...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Trivascular, Inc directly.
Affected Products
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: (1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories, (2) Non-aneurysmal proximal aortic neck: - with a length of at least 7 mm proximal to the aneurysm, - with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and - with an aortic angle of d 60 degrees if proximal neck is e 10 mm and d 45 degrees if proximal neck is < 10 mm, (3) Non-aneurysmal distal iliac landing zone: - with a length of at least 10 mm, - with an inner wall diameter of no less than 8 mm and no greater than 20 mm
Quantity: 41 units
Why Was This Recalled?
Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Trivascular, Inc
Trivascular, Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report