RelayPro Thoracic Stent-Graft System 28-M4-42-195-42URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576149953), received between Jan 28, 2026 and Jan 28, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Lack of Effect” (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.

• InjuryJan 28, 2026Lack of Effect

  "DISSECTION (RETROGRADE TYPE A DISSECTION ORIGINATING FROM THE TIP OF THE STENT GRAFT FABRIC): ON (B)(6) 2025, A TWO-DEBRANCHING TEVAR WAS PERFORMED. FIRST, A RELAY PRO NBS (28-N4-32-209-28U) WAS PLACED DISTALLY, FOLLOWED BY THE RELAY PRO BS (28-M4-42-195-42U) PLACED PROXIMALLY. THE LEFT SUBCLAVIAN ARTERY AND LEFT COMMON CAROTID ARTERY WERE EMBOLIZED WITH COILS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY VISIBLE LEAK. POSTOPERATIVELY, AN ABNORMAL INFLAMMATORY RESPONSE PERSISTED, SO A CONTRAST-ENHANCED CT SCAN WAS PERFORMED ON (B)(6), WHICH CONFIRMED RETROGRADE TYPE A AORTIC DISSECTION. AN EMERGENCY OPERATION WAS PLANNED TO PERFORM ASCENDING AORTIC REPLACEMENT AND LEFT BRACHIOCEPHALIC ARTERIAL RECONSTRUCTION. PHYSICIAN'S COMMENT: IN THIS CASE, A TWO-DEBRANCHING TEVAR WAS PERFORMED FOR TYPE B AORTIC DISSECTION. SUBSEQUENTLY, R-TAD DEVELOPED. WHILE THE PHYSICIAN BELIEVES THIS WAS THE ONLY AVAILABLE TREATMENT OPTION, IT MAY HAVE BEEN PREFERABLE TO USE A DEVICE ONE SIZE SMALLER. CAUSALITY BETWEEN THE PRODUCT AND THE EVENT CANNOT BE DENIED AS THE DISSECTION ORIGINATED FROM THE TIP OF THE STENT-GRAFT FABRIC. OPERATION TYPE: TWO-DEBRANCHING TEVAR BLOOD LOSS: THERE WAS BLOOD L

  Patient problems: Vascular Dissection

  MAUDE report 24202784 ↗

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