TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in

FDA device recall Z-0288-2013 · posted 2012-11-13 · Terminated

Recall details

Recalling firm

Trivascular, Inc

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MIH

Quantity affected

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 t

Date initiated

2012-10-19

Date posted

2012-11-13

Date terminated

2012-12-17

Location

Santa Rosa, CA