RelayPro Thoracic Stent-Graft System 28-M4-40-145-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150171), received between Aug 13, 2025 and Aug 13, 2025 — classified as 1 injury.

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

• InjuryAug 13, 2025Inadequacy of Device Shape and/or Size; Failure to Advance; Inadequacy of Device Shape and/or Size; Failure to Advance

  "BROKEN: THE RELAY PRO STENT GRAFT WAS USED FOR A PATIENT WITH POOR ACCESS AND A SEVERELY BENT DESCENDING AORTA. AFTER 2-DEBRANCHING PROCEDURE, TEVAR WAS PERFORMED ON THE AORTIC ARCH. DUE TO THE DIFFERENCE IN VESSEL DIAMETER BETWEEN THE CENTER AND PERIPHERAL SIDES, A RELAY PRO STENT GRAFT (28-N4-34-109-34U, LOT # 2503180106) WAS FIRST INSERTED ON THE PERIPHERAL SIDE USING THE PULL-THROUGH TECHNIQUE. AT THAT TIME, THE STENT GRAFT WAS DELIVERED OVER THE GUIDEWIRE WHILE THE GUIDEWIRE WAS MOVED FORWARD AND BACKWARD TO RELEASE SLACK, BUT IT WAS DIFFICULT TO DELIVER THE STENT GRAFT. THE STENT GRAFT WAS THEN SOMEHOW DELIVERED TO THE INTENDED SITE AND DEPLOYED. THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED. THEN, THE OUTER SHEATH OF THE RELAY PRO STENT GRAFT CONCERNED WAS ADVANCED TO ZONE 1 USING THE PULL-THROUGH TECHNIQUE. HOWEVER, THE STENT GRAFT COULD NOT PASS THROUGH THE BEND OF THE IMPLANTED RELAY PRO STENT GRAFT, WHICH PREVENTED THE STENT GRAFT FROM BEING DELIVERED. AT A CERTAIN POINT, THE PHYSICIAN ROTATED THE DEPLOYMENT GRIP WITH THE CONTROLLER IN THE "1" POSITION IN AN ATTEMPT TO ADVANCE THE INNER SHEATH. HOWEVER, ONLY THE GRIP ROTATED; THE INNER SHEATH DID NOT ADVANCE. ASSUMING THAT

  Patient problems: Perforation

  MAUDE report 22796528 ↗

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