Ovation iX Iliac Stent Graft TV-IL1416120-JRecalls & reported problems
Endologix LLC · The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated. · Class 3 · Implant
All models of Ovation iX Iliac Stent Graft (66)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850007370251), received between Jan 3, 2023 and Apr 21, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).
3 other recalls cover devices cleared under the same FDA submission (P120006); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Malposition of Device1
- Material Puncture/Hole1
Patient problems
- Aneurysm1
- Clinical Endoleak1
- Failure of Implant1
- Ischemia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2025Malposition of Device; Deformation Due to Compressive Stress; Malposition of Device; Deformation Due to Compressive Stress
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 REPORTEDLY IDENTIFIED THAT THE SURGEON HAD INADVERTENTLY DEPLOYED BOTH LEFT AND RIGHT OVATION ILIAC LIMBS IN THE IPSILATERAL GATE. BECAUSE BOTH LIMBS ARE IN THE IPSILATERAL GATE THE LIMB TO THE LEFT ILIAC SYSTEM IS COMPRESSED CAUSING CLAUDICATION SYMPTOMS FROM LIMITED FLOW TO THE LEFT LEG. REINTERVENTION WAS COMPLETED ON OR AROUND (B)(6) 2025 BY IMPLANTING (NON-ENDOLOGIX) PRODUCTS TO FIX THE ISSUE. THE REP STATED EVERYTHING LOOKED GOOD, THERE WERE NO ENDOLEAKS. THE FINAL PATIENT STATUS WAS NOT PROVIDED.
Patient problems: Ischemia
MAUDE report 21877483 ↗InjuryJan 3, 2023Material Puncture/Hole; Material Puncture/Hole
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY NINE (9) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN EXPANDING AAA SAC (UNKNOWN DIAMETER) AND A POTENTIAL TYPE IIIB ENDOLEAK OF ONE OF THE ILIAC LIMBS. THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. PATIENT'S CURRENT STATUS IS UNKNOWN.
Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant
MAUDE report 16089667 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P120006. One submission often covers many models, so check the product and lot details in each record.
- Z-2263-2020 · May 6, 2020 · TerminatedOvation 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
- Z-0125-2015 · Sep 20, 2014 · TerminatedOvation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device deliver
- Z-0288-2013 · Oct 19, 2012 · TerminatedTriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The
Other System, Endovascular Graft, Aortic Aneurysm Treatment devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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