Z-2263-2020Class I

Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J...

Name: Z-2263-2020 Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J...
Creator: Endologix, Inc.
Published: 2020-05-06
License: https://open.fda.gov/license/

Endologix LLC / initiated 2020-05-06 / Terminated / root cause: manufacturing process

FDA source

Endologix, Inc. began a recall of 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... on 2020-05-06. FDA classified it as Class I and gives the reason as "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...". 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-2263-2020
Classification: Class I
Status: Terminated
Initiated: 2020-05-06
Posted: 2020-06-11
Terminated: 2024-05-03
Recalling firm: Endologix LLC
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
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: All Lot and Serial Numbers not yet implanted

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2263-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2263-2020	Class I	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10

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)