Endologix, Inc.: Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J

Recall number

Z-2263-2020

Recalling firm

Endologix, Inc.

Product

Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J

Status

Terminated

Initiated

2020-05-06

Posted

2020-06-11

Terminated

2024-05-03

Reason

A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.

Root cause

Process control

Action

On 05/06/20, "Urgent Medical Device Correction notices" were distributed to customers via person/mail/email. These notices reaffirmed treatment recommendations for patients provided in the previously distributed Urgent Field Safety Notice, dated 09/26/2018 that were mailed on 09/27/18. Safety Update: Treatment of a Patient with Polymer Leak - Patient Reaction During the polymer injection step of the procedure, systemic hypotension may indicate that a polymer leak is occurring. Blood pressure monitoring during polymer fill may assist in early identification of a potential polymer leak. In the absence of other obvious diagnoses causing sudden hypotension during polymer fill, firm recommends that a hypersensitivity reaction (an anaphylactoid response) to intravascular polymer leak be considered a probable diagnosis. Patients with a polymer leak should undergo immediate treatment for a potential severe hypersensitivity response in accordance with institutional protocols (e.g., intravascular fluids, antihistamines, corticosteroids, epinephrine). In addition to systemic hypotension, device related findings that are indicative of a polymer leak include rapid emptying of the fill polymer syringe, and incomplete filling of the polymer channels. Safety Update: Treatment of a Patient with Polymer Leak - Aneurysm Management Aneurysm related complications that may occur due to polymer leak should be treated with standard endovascular techniques at the physician's discretion, utilizing the ancillary equipment listed in the Instructions for Use (IFU), or an open surgical approach. The specific treatment will be dependent on the extent and location of incomplete filling of the polymer rings and the associated clinical findings. In respect of intra-operative Type 1a endoleaks resulting from polymer leak, there were two main treatment strategies: (1) conservative management (in the cases of small endoleaks expected to resolve spontaneously) or (2) the use of balloon expand

Quantity

9156

Distribution

Worldwide DIstribution: U.S (nationwide).: PA, AZ, NY, FL, HI, CA, OR, IL, MS, AR, WI, KY, TX, TN, MO, NJ, MA, MT, VA, MI, CO, WV, NC, NH, NV, CT, ME, WY, OH, OK, IN, UT, AL, WA, GA, SC, KS, LA, NM, MD, DC, NE, SD, RI, IA, VT, ND. and Countries of:: Argentina, Australia, Chile, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Taiwan, Thailand, Canada, Austria, Belgium, Cyprus, Czech Republic, Germany, Hungary, Ireland, Italy, Switzerland, Luxembourg, Netherlands, Poland, Portugal, Romania, Spain, Sweden, and United Kingdom

Lot, serial or model codes

All Lot and Serial Numbers not yet implanted

510(k) numbers

not on file

PMA numbers

["P120006"]

Product code

MIH

Firm FEI

3008011247

Firm city

Santa Rosa

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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