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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576149816), received between Dec 19, 2024 and Dec 19, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult 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.

• InjuryDec 19, 2024Difficult to Advance; Insufficient Device Problem Information; Difficult to Advance; Insufficient Device Problem Information

  "PATIENTS WAS SCHEDULED FOR TEVAR PROCEDURE ON (B)(6)2024. PROCEDURE WAS GOING WELL UNTIL "S" THORACIC AORTIC WOULD NOT STRAIGHTEN OUT WITH 2 BILATERAL LUNDQUIST WIRES. THE FIRST DEVICE WAS ABLE TO ADVANCE THE TRANSFERS AORTA BUT NO FURTHER DUE TO THE ANGULATION OF THE THORACIC AORTA. THE DEVICE WAS DEPLOYED 4CM DISTAL TO LSA WITHOUT INCIDENT. THE 2ND DEVICE NEEDED TO BE ADVANCED PROXIMALLY TO EXISTING STENT GRAFT JUST DISTAL TO LSA. THE DECISION WAS TO USE BODY-FLOSS FROM THE RIGHT BRACHIAL TO RIGHT FEMORAL TO CREATE ENOUGH TENSION ON THE WIRE TO RAIL THE DEVICE. THIS WAS DONE SUCCESSFULLY BUT THE DISTAL ANGIOGRAM SHOWED AN AORTIC DISSECTION. THIS DECISION WAS TO LEAVE IT ALONE AS THE DISSECTION DID NOT EXTEND ABOVE EXISTING STENT GRAFT OUR BELOW EXISTING ABDOMINAL STENT GRAFT. ON (B)(6)2024 AT 1330 THE PHYSICIAN CALLED ME TO INFORM ME THAT THE PATIENT'S HEMOGLOBIN HAD DECREASED, AND CT WAS ORDERED AND SHOWS A THORACIC RUPTURE AT THE LEVEL OF THE VISCERAL VESSELS. PHYSICIAN HAS DECIDED TO NOT TREAT AS THE PATIENT IS 85 YEARS OLD AND HAS OTHER CO-MOBILITIES. (PHYSICIAN SENT ME VIDEO OF CT THAT SHOWS RUPTURE)." PATIENT OUTCOME: "PATIENT CURRENTLY IS STABLE, BUT HOSPICE HAS BEEN CONT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Rupture; Vascular Dissection

  MAUDE report 20982027 ↗

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