RelayPro Thoracic Stent-Graft System 28-M4-36-250-32URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150355), received between Feb 18, 2025 and Feb 18, 2025 — classified as 1 malfunction.

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.

• MalfunctionFeb 18, 2025Failure to Advance; Unintended Movement; Failure to Advance; Unintended Movement

  "UNABLE TO ADVANCE THE INNER SHEATH / BROKEN: AFTER AORTIC ARCH REPLACEMENT, THE RELAY PRO STENT GRAFT WAS PLANNED TO BE IMPLANTED IN THE PERIPHERAL LSA BRANCH. THE RELAY PRO WAS INSERTED INTO THE PATIENT'S BODY VIA THE LEFT FEMORAL ARTERY AND DELIVERED AS USUAL. THE DEPLOYMENT GRIP WAS ROTATED CLOCKWISE TO ADVANCE THE INNER SHEATH FROM THE PERIPHERAL SIDE OF THE CURVE OF THE AORTIC ARCH AS PER PROCEDURE. THERE WAS SLIGHT RESISTANCE HALFWAY, BUT THE PHYSICIAN CONTINUED TO ROTATE THE DEPLOYMENT GRIP. ROTATION OF THE DEPLOYMENT GRIP BECAME EASY AS IF THE TENSION WAS RELEASED, BUT THE INNER SHEATH DID NOT APPEAR TO ADVANCE. THE DELIVERY SYSTEM WAS CHECKED AND THE GRAY GRIP AND OUTER SHEATH WERE SEPARATED. THE RELAY PRO WAS THEN WITHDRAWN AND SUCCESSFULLY REMOVED FROM THE PATIENT. THE RELAY PRO WAS REPLACED WITH ANOTHER RELAY PRO (28-M4-34-250-30U) TO CONTINUE THE PROCEDURE. THE SECOND RELAY PRO WAS SUCCESSFULLY INSERTED, DELIVERED AND IMPLANTED JUST BELOW THE LSA. AN AFX VELA PROXIMAL ENDOGRAFT SYSTEM (JAPAN LIFELINE) WAS INSERTED INTO THE PATIENT'S BODY VIA THE RIGHT FEMORAL ARTERY WITH THE CENTRAL END PORTION OF THE STENT GRAFT CLOSED BY PROCESSING AND IMPLANTED IN THE FALSE LUMEN S

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398735 ↗

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