RelayPro Thoracic Stent-Graft System 28-N4-34-109-34URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150478), received between Jul 30, 2025 and Jul 30, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  (B)(6): ON (B)(6) 2025, TEVAR WAS PERFORMED TO TREAT A THORACIC AORTIC ANEURYSM AND THE RELAY PRO STENT-GRAFT WAS IMPLANTED. DUE TO THE LARGE DIFFERENCE BETWEEN THE PROXIMAL AND DISTAL VESSEL DIAMETERS, TWO STENT-GRAFTS WERE PLANNED TO BE IMPLANTED. AFTER A RELAY PRO STENT-GRAFT (28-N4-34-109-34U, 2503120074) WAS IMPLANTED IN THE DESCENDING THORACIC AORTA ON THE DISTAL SIDE, THE RELAY PRO STENT-GRAFT CONCERNED (28-N4-42-204-42U, 2502270212) WAS IMPLANTED FROM RIGHT UNDER THE LEFT SUBCLAVIAN. THE STENT-GRAFTS WERE IMPLANTED AS PLANNED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2025, THE PHYSICIAN INFORMED THE SALES REPRESENTATIVE THAT THE PATIENT WAS IN PARAPARESIS AND WAS NOT RECOVERING YET. RIGHT AFTER THE PROCEDURE ON (B)(6) 2025, THE PATIENT'S LEGS WERE RESPONSIVE, BUT THE PATIENT'S LEGS BECAME UNRESPONSIVE FROM THE NEXT DAY. ALTHOUGH A SPINAL DRAINAGE WAS PERFORMED, THE PATIENT HAD NOT RECOVERED AS OF ON (B)(6) 2025. PHYSICIAN'S COMMENTS (INCLUDING COMMENTS ON CAUSALITY): THE PATIENT ORIGINALLY HAD A SHAGGY AORTA SYNDROME, AND IT WAS IMPOSSIBLE TO IMPLANT THE STENT-GRAFT ANY SHORTER DUE TO THE LENGTH OF THE TREATMENT SITE. THE RELAY PRO WAS THE ONLY DEVICE WHOSE D

  Patient problems: Paraplegia

  MAUDE report 22665601 ↗

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