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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150065), received between Sep 2, 2025 and Sep 2, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjurySep 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  "DISSECTION: THE RELAY PRO STENT GRAFT WAS IMPLANTED DURING THE TEVAR PROCEDURE PERFORMED ON (B)(6) 2025. IT IS UNCLEAR WHEN THE RTAD (RETROGRADE TYPE A AORTIC DISSECTION) WAS OBSERVED, BUT IT WAS CONFIRMED AFTER THE PROCEDURE. THE PATIENT IS SCHEDULED TO BE HOSPITALIZED STARTING ON (B)(6). ADDITIONAL TREATMENT IS PLANNED, BUT THE TYPE OF TREATMENT HAS NOT YET BEEN DECIDED. PHYSICIAN'S COMMENT: THE DEVICE SIZE WAS ACCURATE, AND THE OVERSIZE RATE WAS WITHIN AN ACCEPTABLE RANGE. SINCE ADDITIONAL TREATMENT IS REQUIRED, THE PATIENT IS SCHEDULED TO BE HOSPITALIZED STARTING ON (B)(6). HOWEVER, THE TREATMENT PLAN HAS NOT YET BEEN DECIDED. PHYSICIAN'S COMMENT ON CAUSAL RELATIONSHIP: SINCE RTAD WAS CONFIRMED AFTER THE RELAY PRO WAS IMPLANTED, THERE IS A CAUSAL RELATIONSHIP. OPERATION TYPE: TEVAR, BLOOD LOSS: AMOUNT UNKNOWN, NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY, NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY, NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY, (TC#: (B)(6)." PATIENT OUTCOME: "THE DETAILS OF THE PATIENT'S OUTCOME ARE UNKNOWN, BUT THE PATIENT DEVELOPED THE RTAD. ADDITIONAL TREATMENT IS PLANNED."

  Patient problems: Vascular Dissection

  MAUDE report 22944801 ↗

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