RelayPro Thoracic Stent-Graft System 28-M4-30-200-30URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576149892), received between Oct 23, 2025 and Oct 23, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionOct 23, 2025Mechanical Problem; Difficult to Advance; Mechanical Problem; Difficult to Advance

  "A 30X200MM RELAY PRO BARE STENT WAS INTRODUCED THROUGH THE PATIENTS RIGHT COMMON "FEMORAL" "ARTERY". THE DEVICE WAS POSITIONED IN THE "APPROPRIATE" LOCATION OF THE "DESCENDING" AORTA PROXIMAL TO THE CELIAC ARTERY. THE PHYSICIAN "VERIFIED" THE DEVICE WAS IN POSITION 1 ON THE CONTROLLER AND BEGAN TO ROLL THE BLACK DEPLOYMENT GRIP CLOCKWISE (AWAY FROM HIM) TO ADVANCE THE INNER SHEATH INTO THE APPROPRIATE POSITION. THE INNER SHEATH DID NOT RESPOND AND REMAINED IN THE PRIMARY SHEATH. THE PHYSICIAN THEN PRESSED THE BLACK DISENGAGEMENT BUTTON AND ADVANCED THE INNER SHEATH MANUALLY. WHEN THE PROXIMAL END OF THE INNER SHEATH WAS IN POSITION, DISTAL TO THE LSA, WE NOTICED THAT THERE WAS STILL ONE STENT REMAINING IN THE PROXIMAL SHEATH. HOWEVER, THE DISENGAGEMENT BUTTON WAS MOVED ALL THE WAY FORWARD MEETING THE CONTROLLER AND COULD NOT BE "ADVANCED" ANY FARTHER. THE PHYSICIAN TRIED ROLLING THE DEPLOYMENT GRIP AGAIN AND STILL NO RESPONSE FROM THE INNER SHEATH. WE CALLED SEVERAL ASSOCIATES IN THE FIELD AS WELL AS ENGINEERING FOR SOME BAIL OUTS AND WORK AROUNDS. IN THE END, THE PHYSICIAN WAS ABLE TO "ACCORDION, TRAIN-WRECK", THE PRIMARY SHEATH ON ITSELF BY HAVING THE FELLOW PUSH THE DEVICE FORW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368116 ↗

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