RelayPro Thoracic Stent-Graft System 28-M4-40-195-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150270), received between Oct 16, 2024 and Jan 15, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Endoleak” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "DURING THE EARLY FOLLOW-UP A TYPE 1B ENDOLEAK WAS FOUND ON THE IMAGING. CONTRAST MATERIAL IN EXCLUDED SAC AT THE DISTAL ASPECT OF THE STENT, WHICH THE PI DEEMED RELATED TO MAIN BODY OF DEVICE. SUBJECT ALSO HAD LOWER EXTREMITY PARESTHESIA. WEAKNESS, TINGLING, AND NUMBNESS IN BOTH LEGS FROM LOW BLOOD PRESSURE." PATIENT OUTCOME: "PI MONITORING EVENT; AND DETERMINE IF INTERVENTION IS NEEDED."

  Patient problems: Clinical Endoleak; Neuropathy

  MAUDE report 21162261 ↗
• InjuryOct 16, 2024Device Endoleak; Device Endoleak

  "ENDOLEAK (TYPE IIIA): STENT-GRAFT IMPLEMENTATION WAS PERFORMED TO TREAT A DESCENDING AORTIC ANEURYSM. A STENT-GRAFT (28-N4-34-209-34U) WAS FIRST IMPLEMENTED ON THE DISTAL SIDE AND THE STENT-GRAFT (28-M4-40-195-36U) WAS THEN IMPLEMENTED ON THE PROXIMAL SIDE. POST DILATATION WAS PERFORMED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ONE WEEK AFTER THE PROCEDURE, HOWEVER, CONTRAST-ENHANCED CT REVEALED A TYPE IIIA ENDOLEAK. SINCE THE PATIENT IS OLD, THE PATIENT IS BEING FOLLOWED UP. IF THE ANEURYSM TENDS TO ENLARGE, ADDITIONAL TREATMENT WILL BE SCHEDULED. OPERATION TYPE: STENT GRAFT IMPLANTATION. BLOOD LOSS: UNKNOWN. ANCILLARY DEVICE USED: 28-N4-34-209-34U. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE (SEE THE ATTACHED SCHEMA.) ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED. (TC# (B)(6))." PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: Clinical Endoleak

  MAUDE report 20465866 ↗

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