Zenith TX2 Pro-Form G53437Recalls & reported problems
William Cook Europe ApS · Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Component · Class 3 · Implant
All models of Zenith TX2 Pro-Form (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002534374), received between Jan 29, 2019 and Jan 29, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
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.
Most reported problems
Device problems
- Migration1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2019Migration; Migration
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, THE PATIENT RECEIVED ZTEG-2P-40-162-PF-US (LOT #E3179627) AND ZTEG-2P-40-162-PF-US (LOT #E2838030) UNDER GENERAL ANESTHESIA. A CODA-2-10.0-35-120-40 MOLDING BALLOON WAS USED WITHOUT DIFFICULTY OR COMPLICATION. NO ADVERSE EVENTS WERE REPORTED RELATED TO THE IMPLANT PROCEDURE. THE PATIENT HAS BEEN FOLLOWED BY A SERIES OF CTS (DATES: (B)(6) 2014, (B)(6) 2014, (B)(6) 2015, (B)(6) 2016, AND (B)(6) 2017) WITH NO DEVICE RELATED ISSUES REPORTED. A (B)(6) 2018 CT REVEALED CRANIAL MIGRATION. ANALYSIS NOTED ¿BOTH L6 AND L7 ARE SIGNIFICANTLY GREATER THAN ON PRIOR STUDIES. WHILE THE AORTA HAS ELONGATED, THERE IS NOW ALSO EVIDENCE OF DEVICE MOVEMENT BASED ON AN AORTIC WALL CALCIFICATION BEST SEEN ON THE 3D RECONSTRUCTIONS.¿ IN ADDITION, A POSSIBLE ENDOLEAK HAS BEEN REPORTED. ANALYSIS NOTED ¿THERE ARE 2 NEW AREAS OF INCREASED DENSITY WITHIN THE TAA SAC OUTSIDE THE ENDOGRAFT. ONE MOST LIKELY IS NEW CALCIFICATION, BUT THE OTHER MAY REPRESENT A SMALL ENDOLEAK. THIS IS NOT A TYPE I ENDOLEAK IF IT IS AN ENDOLEAK, BUT COULD BE A TYPE II OR TYPE III. THESE ARE NOT SEEN ON 24 MONTH OR 36 MONTH STUDIES, BUT THE CURRENT STUDY IS HIGHER QUALITY WITH M
Patient problems: No Code Available
MAUDE report 8284770 ↗
Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices
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- 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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