RelayPro Thoracic Stent-Graft System 28-N4-30-164-30URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150584), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Retraction Problem” (1 report).

2 FDA recall records name this device's identifier, 1 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. Feb 22, 2024Class IICompleted

   The stent-graft inside the delivery system was the incorrect size.

   Z-1383-2024 · 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.

• MalfunctionOct 15, 2025Retraction Problem; Retraction Problem

  "DELIVERY SYSTEM FAILURE: WHEN THE STENT GRAFT WAS DEPLOYED WITH THE CONTROLLER IN POSITION 2, THE DEPLOYMENT GRIP COULD NOT BE RETRACTED. THE STENT GRAFT COULD BE DEPLOYED BY ROTATING THE DEPLOYMENT GRIP, AND THE DEVICE WAS IMPLANTED IN THE DESIRED POSITION. ANOTHER RELAY PRO DEVICE WITH THE SAME CATALOG AND LOT NUMBER WAS USED ON THIS PATIENT, BUT THE SAME EVENT OCCURRED. THE STENT GRAFT COULD BE DEPLOYED BY ROTATING THE DEPLOYMENT GRIP, AND THE DEVICE WAS IMPLANTED IN THE DESIRED POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR BLOOD LOSS: NO BLOOD LOSS IMAGE AVAILABLE UPON REQUEST PRE-CASE PLAN AVAILABLE UPON REQUEST ADDITIONAL INFORMATION AVAILABLE UPON REQUEST. TWO SETS OF THE DELIVERY SYSTEMS WILL BE RETURNED. (TC# (B)(4)" PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285442 ↗

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-