RelayPro Thoracic Stent-Graft System 28-M4-36-145-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576149793), received between Feb 24, 2025 and Feb 24, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P200045); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Positioning Problem; Positioning Problem

  "E-MAIL NOTIFICATION RECEIVED FROM CORE LABORATORY ON (B)(6) 2025 REPORTING THE FOLLOWING: MIGRATION OF 20MM IN PROXIMAL DIRECTION (NEW) NOTE, AS PER THE STUDY DATABASE, THIS SUBJECT UNDERWENT AN EXTENSION PROCEDURE ON (B)(6)2025. DEVICE INFORMATION IS INCOMPLETE ON THE FORM BUT IS AS FOLLOWS: 1) RELAYPRO NBS - 28-M4-36-145-36U, 2310250198. 2) RELAYPRO NBS - 28-M4-44-155-44U, 2309150072. CT SCANS (DATED (B)(6)2024) AND AN X-RAY ANGIOGRAPHY (DATED (B)(6)2025) ARE AVAILABLE IN THE MEDIDATA DATABASE AND CAN BE SHARED UPON REQUEST. ADVERSE EVENT REPORTED BY THE SITE IN THE STUDY DATABASE FOR THIS SUBJECT SO FAR: LACTIC ACIDOSIS, RIGHT BUNDLE BRANCH BLOCK, CHRONIC HYPERTENSION, RESPIRATORY FAILURE, VOLUME OVERLOAD, ANEMIA, THROMBOCYTOPENIA, LEUKOCYTOSIS, DYSPHAGIA, HYPERKALEMIA, HYPOMAGNESMIA, SINUS TACHYCARDIA, AND SURGICAL SITE BLEEDING REQUIRING INTERVENTION (RIGHT GROIN PUNCTURE SITE OOZING. REQUIRED SUTURES). THERE WERE NO ISSUES REPORTED BY THE SITE FOLLOWING ANY OF THE IMPLANTS OR ON THE POST-PROCEDURE ASSESSMENTS FORMS IN THE STUDY DATABASE. THE SITE HAS NOT REPORTED ANY DEVICE DEFICIENCIES. SITE HAVE BEEN ADVISED OF THE CORE LABORATORY OBSERVATION WITH A REQUEST TO CONSIDER REP

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Perforation of Vessels

  MAUDE report 21450743 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200045. One submission often covers many models, so check the product and lot details in each record.

• Z-2160-2026 · Apr 22, 2026 · Open, Classified
  RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-
• Z-1383-2024 · Feb 22, 2024 · Completed
  RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 2