RelayPro Thoracic Stent-Graft System 28-N4-42-259-42URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150904), received between Oct 23, 2024 and Apr 25, 2025 — classified as 2 injuries.

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

1 FDA recall record 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. 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 ↗

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.

• InjuryApr 25, 2025Material Invagination; Failure to Align; Insufficient Device Problem Information; Material Invagination; Failure to Align; Insufficient Device Problem Information

  "PT READMITTED, DOES NOT APPEAR AS IF THEY WERE READMITTED DUE TO COMPLICATIONS OF GRAFT IMPLANT. ON FOLLOW UP CT IT APPEARS AS IF THERE IS A RETROFLEXION OF THE PROXIMAL RELAY PRO. PATIENT STILL HAS RUNOFF TO THE LOWER EXTREMITIES IT DR IS CONCERNED ABOUT LONG TERM DURABILITY." PATIENT OUTCOME: "I DO NOT HAVE THE FINAL OUTCOME OF WHAT DR DECIDED TO DO WITH PATIENT BUT THEY WERE STABLE AT TIME OF TALKING WITH THE DOCTOR."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912356 ↗
• InjuryOct 23, 2024Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "SUBJECT PRESENTED A FUSIFORM AORTIC ANEURYSM THAT WAS TREATED WITH TWO RELAY PRO NBS (28-N4-42-259-42U, LOT # 207140275 AND 28-N4-46-164-42U, LOT #2309200249) ON (B)(6)2024. SUBJECT WAS HOSPITALIZED POST PROCEDURE ON (B)(6) 2024 TO REDO TEVAR DUE TO TYPE 1A ENDOLEAK. PI HAS NOT BEEN ABLE TO DETERMINE IF THE ENDOLEAK IS RELATED TO THE PROCEDURE OR DEVICE." PATIENT OUTCOME: "ON (B)(6) 2024 THE ENDOLEAK HAS BEEN DETERMINED RESOLVED WITHOUT SEQUALAE."

  Patient problems: Clinical Endoleak

  MAUDE report 20518054 ↗

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