RelayPro Thoracic Stent-Graft System 28-M4-36-190-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843576149922), received between Jan 15, 2025 and Feb 27, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Endoleak” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Device Endoleak

  "SITE DOCUMENTED IN ELECTRONIC DATA CAPTURE (EDC) SYSTEM THAT THERE WAS NO DEVICE DEFICIENCY DURING OR AFTER THE INDEX OR EXTENSION PROCEDURE AND NO ENDOLEAKS PRESENT AT THE END OF EITHER PROCEDURE. ON POST OPERATIVE DAY 722 (INDEX)/284(EXTENSION), PATIENT (B)(6) HAD A CT SCAN ON (B)(6) 2026 WHICH SHOWED MULTIPLE STABLE UNCLASSIFIED ENDOLEAKS IN THE PROXIMAL STENT AND MIDPORTION OF THE STENT WITH OVERALL STABLE AGGREGATE DIAMETER MEASURING UP TO 7.2CM. (B)(6) 2025, CTA REVEALED INTERVAL GROWTH OF THE PROXIMAL DESCENDING AORTA MEASURING A MAXIMUM OF 7.1 CM IN DIAMETER. FOLLOW-UP IMAGING IN (B)(6) 2025 SHOWED ONGOING LEAK FROM THE DISTAL GRAFT AND ENLA.... (CHARACTER LIMIT REACHED IN THE EDC SYSTEM). TREATMENT OF THE EVENT ON (B)(6) 2026 INCLUDED EXTENSION TEVAR VIA RIGHT CFA CUTDOWN. THE VASCULAR PROCEDURE INCLUDED PERCUTANEOUS ACCESS OF THE RIGHT FEMORAL ARTERY WITH A 7-FRENCH SHEATH, A RIGHT ILIAC ANGIOGRAM, AND A STENTING OF THE RIGHT COMMON ILIAC ARTERY AND EXTERNAL ILIAC A.... (CHARACTER LIMIT REACHED IN EDC SYSTEM). TYPE 1B ENDOLEAK OF A THORACIC ENDOVASCULAR AORTIC REPAIR GRAFT DONE PREVIOUSLY AFTER THE PATIENT HAS AN EXTENSIVE HISTORY OF TYPE A AORTIC DISSECTION AND EXTENSIV

  Patient problems: Clinical Endoleak

  MAUDE report 24473294 ↗
• InjuryApr 17, 2025Malposition of Device; Failure to Seal; Device Endoleak; Malposition of Device; Failure to Seal; Device Endoleak

  "ENDOLEAK TYPE 1A: DURING DEPLOYMENT OF THE PROXIMAL STENT-GRAFT, AS DEPLOYMENT PROGRESSED TO THE SECOND STENT, THE STENT-GRAFT WAS SUBJECTED TO A DISTAL FORCE AND MIGRATED DISTALLY. THE STENT-GRAFT LANDED MORE DISTALLY THAN PLANNED, RESULTING IN INADEQUATE SEALING AT THE PROXIMAL NECK, CAUSING A TYPE 1A ENDOLEAK. NO ADDITIONAL STENT-GRAFT WAS PLACED TO TREAT THE ENDOLEAK DURING THIS OPERATION AS HEALTH INSURANCE WOULD NOT COVER THE PLACEMENT OF A THIRD STENT-GRAFT ON THE SAME DAY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER TREATMENT. AN ADDITIONAL STENT-GRAFT WILL BE IMPLANTED AT A LATER DATE. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE: SCHEMA. ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST. DELIVERY SYSTEM WAS DISCARDED BY USER. (TC#(B)(4))". PATIENT OUTCOME: "THERE WAS NO HARM TO THE PATIENT'S HEALTH."

  Patient problems: Clinical Endoleak

  MAUDE report 21860321 ↗
• InjuryFeb 24, 2025Failure to Seal; Failure to Seal

  "CT IMAGING SHOWED STENT GRAFT INDUCED NEW ENTRY TEAR WITH RAPIDLY GROWING DESCENDING DISTAL AORTIC ANEURYSM. PI DETERMINED THE EVENT RELATED TO THE DEVICE (MAIN BODY). CELIAC ARTERY STENOSIS AND FEVAR UP TO ZONE 6 DISTALLY WAS THE ACTION TAKE REGARDING THIS EVENT. EVENT HAS BEEN RESOLVED WITHOUT SEQUALAE. NOTE THAT AN EVENT INVOLVING THESE DEVICES WAS PREVIOUSLY REPORTED AND INVESTIGATED UNDER COMPLAINT NUMBER (B)(4)." PATIENT OUTCOME: "PI MONITORING EVENT; WILL REVIEW IMAGES AT NEXT F/U."

  Patient problems: Aneurysm expansion

  MAUDE report 21451893 ↗
• InjuryJan 15, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "TYPE 1A ENDOLEAK AS THE PROXIMAL NECK OF THE ANEURYSM WAS SHORT, THE RELAYPRO STENT-GRAFT WAS PLACED PARTIALLY COVERING THE LSA. TYPE 1A ENDOLEAK WAS OBSERVED ON THE LESSER CURVATURE SIDE. THE PATIENT WAS PLACED UNDER OBSERVATION BECAUSE THE ENDOLEAK WAS SMALL. OPERATION TYPE: TEVAR BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY PRE-CASE PLAN AVAILABLE ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST (TC#BM 241202508)" PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH".

  Patient problems: Clinical Endoleak

  MAUDE report 21162193 ↗

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