RelayPro Thoracic Stent-Graft System 28-N4-38-199-34URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576151086), received between May 1, 2024 and Jul 8, 2025 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2025Device Slipped; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Failure to Seal; Device Endoleak; Device Slipped; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Failure to Seal; Device Endoleak

  "TYPE IA ENDOLEAK DUE TO STENT-GRAFT MIGRATION: ON (B)(6) 2023, THE PATIENT HAD THE RELAY PRO STENT-GRAFT IMPLANTED. THIS MONTH, POSTOPERATIVE FOLLOW-UP CT SCAN REVEALED THAT THE STENT-GRAFT, WHICH HAD BEEN IMPLANTED FROM THE POSITION RIGHT BELOW THE LEFT COMMON CAROTID ARTERY, MIGRATED TO THE POSITION OF THE AORTIC ARCH AORTA ANEURYSM RIGHT BELOW THE LEFT SUBCLAVIAN ARTERY, WHICH CAUSED A TYPE IA ENDOLEAK AND ENLARGEMENT OF THE ANEURYSM. THE PHYSICIAN SUGGESTED AN ADDITIONAL PROCEDURE, BUT THE PATIENT AND FAMILY PREFERRED NOT TO HAVE THE PROCEDURE PERFORMED BECAUSE OF THE PATIENT'S ADVANCED AGE. THE PATIENT IS THEREFORE BEING FOLLOWED UP. OPERATION TYPE: TEVAR NO BLOOD LOSS. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. (TC#(B)(4). PATIENT OUTCOME: "HEALTH DAMAGE TO THE PATIENT IS UNKNOWN. DUE TO THE PATIENT'S ADVANCED AGE, NO ADDITIONAL PROCEDURE WAS PERFORMED ACCORDING TO THE WISHES OF THE PATIENT AND FAMILY, AND THE PATIENT IS BEING FOLLOWED UP."

  Patient problems: Aneurysm expansion; Clinical Endoleak; Insufficient Information

  MAUDE report 22440620 ↗
• MalfunctionMay 1, 2024

  A TERUMO AORTIC RELAY PRO 38/34 X 199 MM DEVICE WAS ADVANCED OVER THE LUNDERQUIST WIRE FROM THE LEFT FEMORAL ACCESS. THERE WAS SOME DIFFICULTY ENTERING THE DISTAL ASPECT OF THE PROXIMAL DEVICE WITH THE DELIVERY SYSTEM BUT WITH REPOSITIONING OF THE STIFF WIRE, THE DEVICE WAS ABLE TO ADVANCE WITHOUT DIFFICULTY TO THE PROPER LEVEL OF OVERLAP WITH THE PROXIMAL DEVICE. THE DEVICE WAS THEN SUCCESSFULLY DEPLOYED UNDER FLUOROSCOPIC GUIDANCE WITH THE DISTAL ASPECT TERMINATING JUST ABOVE THE LEVEL OF THE CELIAC ARTERY. THE PROXIMAL CLASPS WERE RELEASED AND THE NOSE CONE WAS ATTEMPTED TO BRING THROUGH THE DISTAL DEVICE; HOWEVER, THE NOSE CONE INADVERTENTLY CAUGHT THE PROXIMAL STENT APEX OF THE SECOND DEVICE AND PULLED THE PROXIMAL PORTION OF THE DEVICE WHICH WAS OVERLAPPED WITH THE INITIAL DEVICE APPROXIMATELY 6-8 CM DOWN, INVOLUTING IT WITHIN THE REMAINDER OF THE DEVICE. THIS WAS OBSERVED UNDER FLUOROSCOPIC GUIDANCE AND REMOVAL OF THE DELIVERY SYSTEM WAS ABORTED. THE DELIVERY SYSTEM WAS THEN CAREFULLY READVANCED WHICH SUCCESSFULLY REPOSITIONED THE PROXIMAL PORTION OF THE SECOND DEVICE MUCH MORE PROXIMALLY BUT NOT AS PROXIMAL AS NEEDED FOR ACCEPTABLE OVERLAP. ADDITIONALLY, THE DEVICE APPEARED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220290 ↗

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