RelayPro Thoracic Stent-Graft System 28-N4-42-204-38URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576151109), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 injury.

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

2 FDA recall records name this device's identifier, 2 still open.

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. Apr 22, 2026Class IOpen, Classified

   Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

   Z-2160-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 20, 2022Class IIOpen, Classified

   The product may be shorter than packaging indicates

   Z-0998-2023 · 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.

• InjuryAug 27, 2025Device Endoleak; Device Endoleak

  "ON (B)(6) 2025 SUBJECT PRESENTED A CHRONIC DISSECTION; DETAILS OF THE PROCEDURE ARE STILL PENDING FROM THE SITE, HOWEVER, THE SITE DID REPORT A TYPE IIIA ENDOLEAK CONFIRMED BY CT AT INDEX PROCEDURE; SITE REPORTED THIS AS RELATED TO PROCEDURE AND DEVICE. PRIOR TO THE PROCEDURE THE SITE STATED THAT THE SUBJECT HAD AN ACUTE ON CHRONIC DISSECTION INVOLVING JUXTA SUPERIOR MESENTERIC ARTERY AORTA EXTENDING DISTALLY INTO RIGHT EXTERNAL ILIAC ARTERY AND INTO DISTAL SUPERIOR MESENTERIC ARTERY. FOLLOWING THE INDEX PROCEDURE, THE SITE REPORTED THAT THE PATIENT DEVELOPED A SMALL ILEUS ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE), CT SCAN SHOWED AN INTRAMURAL HEMATOMA ALONG THE AORTIC ARCH ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE), CT SCAN SHOWED A LEFT PLEURAL EFFUSION WITH COMPRESSIVE ATELECTASIS OF THE LINGULA AND LEFT LOWER LOBE ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE), CT SCAN SHOWED A TREOPERITONEAL AND PELVIC HEMATOMA ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE) AND SIGNIFICANT POST-OP PAIN ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE)." PATIENT OUTCOME: "PENDING COMPLETION OF DATA ENTRY AND SITE WAS ASKED TO UPLOAD ALL IMAGING AND PROVIDE SOURCE DOCUMENTATION.

  Patient problems: Clinical Endoleak

  MAUDE report 22907454 ↗

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-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