RelayPro Thoracic Stent-Graft System 28-M4-28-195-28URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576149885), received between Apr 17, 2025 and Jun 26, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Endoleak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Device Endoleak

  "SUBJECT PRESENTED AN AORTIC ANEURYSM AND WAS TREATED WITH ONE RELAY PRO BARE STENT ON (B)(6) 2023. DURING THE 2-YEAR FOLLOW-UP CT IMAGING SHOWED A TYPE IB ENDOLEAK THAT THE PI DETERMINED NOT RELATED TO THE PROCEDURE AND UNDETERMINED IF RELATED TO THE DEVICE. THIS AE IS ONGOING." PATIENT OUTCOME: "PATIENT WILL BE MONITORED AND IMAGING WILL BE TAKEN AGAIN AT 3Y FOLLOW-UP."

  Patient problems: Clinical Endoleak

  MAUDE report 25636692 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  "SUBJECT PRESENT AN AORTIC ANEURYSM ON (B)(6) 023, RELAYPRO BS WAS USED. DURING THE 2-YEAR FOLLOW-UP VISIT, SITE REPORTED CLINICAL HEART FAILURE (JVP 12, 1+ EDEMA), CARDIOMYOPATHY (POSSIBLE LAD TERRITORY INFARCT) AND SHORTNESS OF BREATH FOR THE SUBJECT." PATIENT OUTCOME: "PI MONITORING SUBJECT."

  Patient problems: Cardiomyopathy

  MAUDE report 21856834 ↗

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