Zenith TX2 Pro-Form G53431Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002534312), received between Oct 9, 2019 and Oct 18, 2019 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PROTOCOL 08-005: PATIENT (B)(6) ¿ ENDOLEAK (TYPE UNKNOWN) ON (B)(6) 2015, THE PATIENT RECEIVED A ZTEG-2P-36-152-PF-US (LOT # E2977967). THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. PER SITE AND CORE LAB, THE DEVICE WAS PATENT WITH NO KINK OR ENDOLEAK ON THE COMPLETION ANGIOGRAM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (ONE DAY POST-PROCEDURE). (B)(6) 2015 (81 DAYS POST-PROCEDURE) FOLLOW-UP CT SCAN: SITE REVIEW: PATENT, INTACT GRAFT WITH NO ENDOLEAK. THE MAXIMUM ANEURYSM DIAMETER MEASURED 61 MM. CORE LAB REVIEW: PATENT, INTACT GRAFT WITH NO EVIDENCE OF KINK OR ENDOLEAK. THE MAXIMUM ANEURYSM DIAMETER MEASURED 62.8 MM AND THE ANEURYSM LENGTH MEASURED 75.2 MM. (B)(6) 2015 (289 DAYS POST-PROCEDURE) SIX-MONTH FOLLOW-UP CT SCAN: SITE REVIEW: PATENT, INTACT GRAFT WITH NO EVIDENCE OF MIGRATION OR ENDOLEAK. THE MAXIMUM ANEURYSM DIAMETER MEASURED 45 MM. CORE LAB REVIEW: PATENT, INTACT GRAFT WITH NO EVIDENCE OF KINK, ENDOLEAK, OR MIGRATION. THE MAXIMUM ANEURYSM DIAMETER MEASURED 51.6 MM AND THE ANEURYSM LENGTH MEASURED 69.6 MM. (B)(6) 2016 (548 DAYS POST-PROCEDURE) 12-MONTH FOLLOW-UP CT SCAN: SITE REV

  Patient problems: No Code Available

  MAUDE report 9209080 ↗
• InjuryOct 9, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 9171214 ↗