RelayPro Thoracic Stent-Graft System 28-N4-32-259-32URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150850), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  "PATIENT (B)(6), A CAUCASIAN FEMALE WITH AORTIC ANEURYSM (FUSIFORM SHAPE), EXPERIENCED AN EVENT OF BILATERAL ARM AND LEG WEAKNESS. THE PATIENT UNDERWENT AN OPEN SURGICAL REPLACEMENT OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2024 AND AN EXTENSION PROCEDURE WITH A RELAYPRO NBS ON THE (B)(6) 2025. FOR THE EXTENSION PROCEDURE THE VASCULAR ACCESS ACHIEVED VIA THE NATIVE LEFT FEMORAL ARTERY. AT THE END OF THE EXTENSION PROCEDURE AN INTENTIONAL ENDOLEAK TYPE IB WAS PRESENT. MEDICAL HISTORY INCLUDES: HYPERTENSION (CONTROLLED BY MEDICATION), ASA CLASS III - SUBJECT WITH SEVERE SYSTEMIC DISEASE, HYPOTHYROIDISM, TEMPORAL ARTERITIS, LEFT BREAST CANCER WITH LYMPH NODE REMOVAL AND CHEMO AND XRT, CURRENT SMOKER. SURGICAL HISTORY INCLUDES: NONE IS INDICATED IN THE EDC. EXTENSION DEVICE INFORMATION: PRODUCT TYPE: RELAYPRO NBS CATALOGUE NUMBER: 28-N4-32-259-32U LOT NUMBER: 2407100272 UDI NUMBER: (B)(4). SITE DOCUMENTED IN ELECTRONIC DATA CAPTURE (EDC) SYSTEM THAT THERE IS NO DEVICE DEFICIENCY. ON POST OPERATIVE DAY 322 AND POST EXTENSION DAY 49 (B)(6) 2025), PATIENT (B)(6) HAD A BILATERAL ARM AND LEG WEAKNESS (PT ARRIVED FROM OR AROUND 2130, IMMEDIATELY STROKE ALERTED DUE TO RIGHT

  Patient problems: Neuropathy

  MAUDE report 24781549 ↗

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