RelayPro Thoracic Stent-Graft System 28-N4-44-209-44URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150782), received between Jul 15, 2025 and Jul 15, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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.

• InjuryJul 15, 2025Material Deformation; No Apparent Adverse Event; Material Deformation; No Apparent Adverse Event

  "STENT-GRAFT INFOLDING OF UNKNOWN CAUSE: FOR TREATMENT OF DESCENDING AORTIC ANEURYSM, THE STENT-GRAFT CONCERNED (28-N4-44-209-44U) WAS PLACED PROXIMALLY AND A STENT-GRAFT (28-N4-34-109-34U) WAS PLACED DISTALLY. THERE WAS ALSO AN AORTIC ARCH ANEURYSM, AND THE LESSER CURVATURE SIDE OF THE FIRST STENT OF THE PROXIMAL STENT-GRAFT PROTRUDED APPROXIMATELY 1 CM INTO THE ANEURYSM (BIRD BEAK). HOWEVER, THERE WAS NO ENDOLEAK, AND THE PROCEDURE WAS COMPLETED. POST-OPERATIVE CT SCAN REVEALED SIGNIFICANT INFOLDING FROM THE FIRST TO SECOND STENT ON THE LESSER CURVATURE SIDE AND CONTRAST MEDIUM HAD FLOWED OUTSIDE THE STENT-GRAFT. HOWEVER, NO ENDOLEAK WAS OBSERVED, SO NO ADDITIONAL TREATMENT WAS REQUIRED. OPERATION TYPE: STENT-GRAFTING BLOOD LOSS: UNKNOWN NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY PRE-CASE PLAN AVAILABLE: SCHEMA ATTACHED ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST DELIVERY SYSTEM WAS DISCARDED BY USER ANCILLARY DEVICES USED: 28-N4-34-109-34U. (TC# (B)(4). PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512893 ↗

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