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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150058), received between Sep 28, 2026 and Sep 28, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 20, 2022Class IIOpen, Classified

   The product may be shorter than packaging indicates

   Z-0997-2023 · Root cause: Labeling Change Control · 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.

• MalfunctionSep 28, 2026Failure to Advance

  "Introduced a 24FR Gore dry seal on the patients right. Used ivus to determine proper landing zone in the arch. 36X250 Relay Pro was prepped with saline verified control knob was in position 1 and introduced in patient. Device was then removed to perform angiogram with contrast. Device was introduced to distal landing zone and Dr Chou started deploying graft by turning deployment grip away from him. The inner sheath advanced so that a little more than half of the stent was out of the outer sheath. At this point device would not advance anymore. Dr Chou pressed the disengagement button and tried to advance inner sheath, and there was no movement. At this point we noticed that the control knob was slightly out of the pocket in position one. Dr Chou adjusted that and we still had no luck in advancing device to the proper landing zone in the arch. At this point the device was put in position 2 and removed from patient. Dr Chou then proceeded to put 2 Gore Thoracic devices in and finish the case. The surgical tech had the relay pro on the back table and in going from position 2 and then position 1 and back to position 2 while turning deployment grip, the inner sheath finally was out of

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910583 ↗

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