RelayPro Thoracic Stent-Graft System 28-M4-38-250-34URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150362), received between Mar 10, 2025 and Jun 27, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Failure to Advance” (2 reports).

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

• InjuryJun 27, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  "UNABLE TO ADVANCE THE INNER SHEATH / PARAPLEGIA (SUSPECTED) ON SATURDAY, (B)(6), TAR + FET WAS PERFORMED FOR THE ARCH AND DESCENDING AORTIC ANEURYSM. (J GRAFT (26 MM, JAPAN LIFELINE)) AND FROZENIX (35 MM × 120 MM, JAPAN LIFELINE). ON MONDAY, (B)(6), TEVAR WAS PERFORMED USING THE RELAY PRO STENT GRAFT. CUTDOWN WAS PERFORMED IN THE RIGHT FA. A DRYSEAL (22 FR, GORE) WAS INSERTED. THE RELAY PRO STENT GRAFT (28-M4-38-250-34U) WAS INSERTED. THE INNER SHEATH OF THE STENT GRAFT WAS ATTEMPTED TO BE ADVANCED THROUGH THE IMPLANTED FROZENIX STENT GRAFT, BUT THE DELIVERY SYSTEM TIP WAS CAUGHT IN THE PERIPHERAL PORTION OF THE FROZENIX, WHICH CAUSED DIFFICULTY ADVANCING THE RELAY PRO. IT WAS DETERMINED THAT THE RELAY PRO COULD NOT BE DELIVERED ANY FURTHER; THEREFORE, THE IMPLANTATION PLAN WAS CHANGED. FIRST, THE RELAY PRO WOULD BE IMPLANTED IN THE INITIALLY INTENDED PERIPHERAL LOCATION, AND THEN ANOTHER STENT WOULD BE STACKED. THE RELAY PRO WAS SUCCESSFULLY IMPLANTED SLIGHTLY ABOVE THE CELIAC ARTERY. A CTAG (40 × 200, GORE) WAS SELECTED AS THE STACKED STENT GRAFT. THE TIP OF THE CTAG WAS ALSO CAUGHT IN THE PERIPHERAL PORTION OF THE FROZENIX. HOWEVER, THE CTAG COULD BE ADVANCED MORE CENTRALLY THA

  Patient problems: Paraplegia

  MAUDE report 22349897 ↗
• DeathMar 10, 2025Failure to Advance; Failure to Advance

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

  Patient problems: Perforation of Vessels

  MAUDE report 21562007 ↗

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