RelayPro Thoracic Stent-Graft System 28-M4-44-200-40URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150294), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 injury.

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

2 other recalls 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.

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.

• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Failure to Seal; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Failure to Seal; Device Endoleak

  "ENDOLEAK (TYPE1A): ONLY TWO-DEBRANCHING PROCEDURE WAS PERFORMED THE DAY BEFORE TEVAR AND ONLY TEVAR WAS PERFORMED ON (B)(6). AS PER THE STANDARD PROCEDURE, 28-N4-36-109-36U (2310160270) WAS IMPLANTED PERIPHERALLY AND THE RELAYPRO CONCERNED WAS ATTEMPTED TO BE IMPLANTED CENTRALLY FROM JUST BELOW THE BCA. THE RELAYPRO WAS IMPLANTED, BUT IT COULD NOT BE SUFFICIENTLY CONFIRMED WHETHER THE BCA WAS COMPLETELY COVERED WITH THE RELAYPRO OR NOT. THE FINAL ANGIOGRAPHY SHOWED NO LEAKS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, ON (B)(6), A LEAK WAS CONFIRMED ON POST-OPERATIVE ANGIOGRAPHY. THE PHYSICIAN ALSO SUSPECTED A TYPE 3B ENDOLEAK, BUT WHEN THE PHYSICIAN CHECKED THE ACTUAL IMPLANTATION SITE, THE RELAYPRO WAS IMPLANTED NOT JUST BELOW THE BCA, BUT WHERE IT COVERED HALF OF THE LCCA. THERE IS A POSSIBILITY THAT AN ADDITIONAL TEVAR WILL BE PERFORMED, BUT THIS IS STILL UNDECIDED AT THIS TIME. OPERATION TYPE: TEVAR AFTER 2 DEBRANCHING. ANCILLARY DEVICE: 28-N4-36-109-36U (2310160270). BLOOD LOSS: SMALL AMOUNT. IMAGE AVAILABLE UPON REQUEST. PRE-CASE PLAN AVAILABLE: SCHEMA ATTACHED. ADDITIONAL INFORMATION AVAILABLE UPON REQUEST. (TC#:(B)(4)". PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE

  Patient problems: Clinical Endoleak; Insufficient Information

  MAUDE report 21091868 ↗

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-
• 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