RelayPro Thoracic Stent-Graft System 28-M4-46-155-46URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576149847), received between Feb 27, 2026 and Feb 27, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Device Endoleak” (1 report).

1 FDA recall record name this device's identifier.

1 other recall 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.

Recalls naming this device

1. Feb 22, 2024Class IICompleted

   The stent-graft inside the delivery system was the incorrect size.

   Z-1383-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryFeb 27, 2026Device Endoleak

  "SITE DOCUMENTED IN ELECTRONIC DATA CAPTURE (EDC) SYSTEM THAT THERE WAS NO DEVICE DEFICIENCY DURING OR AFTER THE INDEX OR EXTENSION PROCEDURE AND NO ENDOLEAKS PRESENT AT THE END OF EITHER PROCEDURE. ON POST OPERATIVE DAY 722(INDEX)/284(EXTENSION), PATIENT 025001 HAD A CT SCAN ON (B)(6) 2026 WHICH SHOWED MULTIPLE STABLE UNCLASSIFIED ENDOLEAKS IN THE PROXIMAL STENT AND MIDPORTION OF THE STENT WITH OVERALL STABLE AGGREGATE DIAMETER MEASURING UP TO 7.2CM. ((B)(6) 2025, CTA REVEALED INTERVAL GROWTH OF THE PROXIMAL DESCENDING AORTA MEASURING A MAXIMUM OF 7.1 CM IN DIAMETER. FOLLOW-UP IMAGING IN (B)(6) 2025 SHOWED ONGOING LEAK FROM THE DISTAL GRAFT AND ENLA.... (CHARACTER LIMIT REACHED IN THE EDC SYSTEM). TREATMENT OF THE EVENT ON (B)(6) 2026 INCLUDED EXTENSION TEVAR VIA RIGHT CFA CUTDOWN. THE VASCULAR PROCEDURE INCLUDED PERCUTANEOUS ACCESS OF THE RIGHT FEMORAL ARTERY WITH A 7-FRENCH SHEATH, A RIGHT ILIAC ANGIOGRAM, AND A STENTING OF THE RIGHT COMMON ILIAC ARTERY AND EXTERNAL ILIAC A.... (CHARACTER LIMIT REACHED IN EDC SYSTEM). TYPE 1B ENDOLEAK OF A THORACIC ENDOVASCULAR AORTIC REPAIR GRAFT DONE PREVIOUSLY AFTER THE PATIENT HAS AN EXTENSIVE HISTORY OF TYPE A AORTIC DISSECTION AND EXTENSIV

  Patient problems: Clinical Endoleak

  MAUDE report 24473013 ↗

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-