RelayPro Thoracic Stent-Graft System 28-N4-44-164-44URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150652), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Patient Device Interaction Problem

  "DISTAL STENT GRAFT-INDUCED NEW ENTRY (DSINE): THE PATIENT WHO UNDERWENT TEVAR WITH THE RELAYPRO DEVICE CAME TO THE HOSPITAL WITH CHEST PAIN ON THE EVENING OF NOVEMBER 21. A CT SCAN REVEALED A DSINE IN THE VESSEL WHERE THE PERIPHERAL PART OF THE DEVICE WAS POSITIONED. THE PHYSICIAN DETERMINED TO PERFORM ADDITIONAL TEVAR ON A SEMI-URGENT BASIS ON NOVEMBER 25. A RELAYPRO NBS (28-N4-38-154-38U, 2312110207) WAS IMPLANTED PERIPHERALLY NEAR THE COMMON CELIOMESENTERIC TRUNK, AND THEN A RELAYPRO NBS (28-N4-46-164-42U, 2311150173) WAS IMPLANTED CENTRALLY. CONSIDERING THE POSSIBILITY OF A TYPE 3A ENDOLEAK, A ZENITH ALPHA CUFF (46 MM X 97 MM) WAS ADDITIONALLY IMPLANTED MORE CENTRALLY ON THE IMPLANTED RELAYPRO, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PHYSICIAN'S COMMENT: THIS WAS MY FIRST RELAYPRO CASE, AND I WONDER IF THE SELECTED DIAMETER OF THE DEVICE WAS APPROPRIATE. OPERATION TYPE: TEVAR ANCILLARY DEVICE USED: 28-M4-46-200-46U (2310030017) BLOOD LOSS: AMOUNT IS UNKNOWN. IMAGE AVAILABLE: SEE ATTACHED NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY (TC#(B)(4)" PATIENT OUTCOME: "HEALTH DAMAGE WAS MINOR. THE PATIENT OUTCOME IS

  Patient problems: Chest Pain; Insufficient Information; Vascular Dissection

  MAUDE report 23823786 ↗

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