RelayPro Thoracic Stent-Graft System 28-N4-24-159-24URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150553), received between Feb 18, 2025 and Feb 18, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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-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.

• InjuryFeb 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  "AN EXTENSION PROCEDURE WAS PERFORMED ON (B)(6) 2024 WITH A RELAYPRO NBS (CATALOGUE AND LOT NUMBER AS PROVIDED ON PAGE 1 OF EVENT FORM) AND A GORE C-TAG WITH ACTIVE CONTROL (CATALOGUE NUMBER TGM262610, SERIAL NUMBER (B)(6)). ON POST OPERATIVE DAY 239 ((B)(6) 2024) FROM EXTENSION PROCEDURE, (246 DAYS POST OPERATIVE FROM INDEX PROCEDURE), THE PATIENT EXPERIENCED WORSENING THORACOABDOMINAL AORTA DISSECTION. THERE WAS INCREASING DILATION OF DOWNSTREAM RESIDUALLY DISSECTED THORACOABDOMINAL AORTA AND BILATERAL COMMON ILIAC ARTERIES. THERE IS A PLANNED 2 STAGE HYBRID REPAIR: STAGE 1 - INFRARENAL AORTA-BI-ILIAC REPLACEMENT WITH ABDOMINAL DEBRANCHING. STAGE 2 - COMPLETION TEVAR (INTERPRETED AS THORACIC ENDOVASCULAR AORTIC REPAIR). ON (B)(6) 2025, PLANNED MAJOR OPEN SURGERY WAS PERFORMED: AN AORTO-BI-ILIAC BYPASS WITH DEBRANCHING OF VISCERAL VESSELS (ILIO-COELIAC, ILIO-SMA (INTERPRETED AS SUPERIOR MESENTERIC ARTERY), ILIO-IMA (INTERPRETED AS INFERIOR MESENTERIC ARTERY), ILIO-RENAL (LEFT RENAL, RIGHT RENAL). THE SITE HAVE DOCUMENTED IN EDC THAT THE INTERVENTION REQUIRED WAS NOT AS A RESULT OF A DEVICE DEFICIENCY BUT DID RESULT IN THE IMPLANTATION OF A NEW DEVICE. THE DEVICE INFORMATION SECTIO

  Patient problems: Vascular Dissection

  MAUDE report 21396859 ↗

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