Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The

FDA device recall Z-1297-2014 · posted 2014-03-26 · Terminated

Recall details

Recalling firm

Trivascular, Inc

Reason for recall

Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.

Action taken

Trivascular sent an Important Medical Device Information letter dated February 27, 2014, to all European physicians who have scheduled cases through March 31, 2014 or until IFU;s are translated and available for European physicians. The letter provided notification of an update that will appear in a future revision of the product Instructions for Use (IFU). The IFU will be available in their country when the required translations and product registration/notification have been completed. This IFU does not require rework or return of the affected product. Customers with questions were instructed to contact their local TriVascular representative. For questions regarding this recall call 707-543-8805.

Root cause

Device Design

Status

Terminated

Product code

MIH

Quantity affected

45

Distribution

Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.

Date initiated

2014-02-27

Date posted

2014-03-26

Date terminated

2014-04-11

Location

Santa Rosa, CA