Z-0288-2013Class II

TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number...

Name: Z-0288-2013 TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number...
Creator: Trivascular, Inc
Published: 2012-10-19
License: https://open.fda.gov/license/

Endologix LLC / initiated 2012-10-19 / Terminated / root cause: manufacturing process

FDA source

Trivascular, Inc began a recall of TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only)... on 2012-10-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0288-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-19
Posted: 2012-11-13
Terminated: 2012-12-17
Recalling firm: Endologix LLC
Product: 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
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Trivascular sent an Urgent Field Safety Notice letter dated October 19, 2012 to all affect consignees. A verbal (telephone) communication was also initiated. The forms communication identified the affected product, problem and actions to be taken. Consignees were instructed to immediately quarantine and return affected products. A return response form was included for consignees to complete and returned via the e-mail address or fax number provided. Consignees were instructed to further notify its (sub-level) consignees, and have them return affected product directly to the recalling firm. For questions call 1-707-543-8732.
Quantity in commerce: 41 units
Distribution: Worldwide Distribution - US Nationwide and the countries of Belgium, Cyprus, Italy, Spain, Switzerland and Turkey. TriVascular stated that no purchased devices are in hospital inventory in Europe or the U.S.
Product codes and lots: The following lot numbers are in distributor inventory in Europe: FF121211-04, FF010912-01, FF013112-01, FF020912-01, FF022212-03, FF022912-01, FF040412-01, FF051012-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0288-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0288-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)