RelayPro Thoracic Stent-Graft System 28-M4-36-145-32URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150157), received between Oct 23, 2024 and Feb 24, 2026 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  "IMPLANTATION POSITIONING FAILURE / LEFT COMMON CAROTID ARTERY OCCLUSION: THE RELAYPRO WAS PLANNED TO BE IMPLANTED JUST BELOW THE LEFT SUBCLAVIAN ARTERY (ZONE 2). HOWEVER, THE PHYSICIAN IMPLANTED THE DEVICE MORE CENTRALLY THAN PLANNED, OCCLUDING THE LEFT COMMON CAROTID ARTERY. THE PROCEDURE WAS IMMEDIATELY CHANGED FROM ONE DEBRANCHING TEVAR TO TWO DEBRANCHING TEVAR TO RESTORE BLOOD FLOW. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. ((B)(4))" PATIENT OUTCOME: "THERE WAS NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428774 ↗
• MalfunctionOct 23, 2024Difficult to Insert; Difficult to Advance; Material Integrity Problem; No Apparent Adverse Event; Difficult to Insert; Difficult to Advance; Material Integrity Problem; No Apparent Adverse Event

  "BROKEN/DEFECTIVE (BLACK PORTION AT THE TIP OF THE OUTER SHEATH WAS FOUND TO BE TURNED UP): WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE INSERTED INTO THE FEMORAL ARTERY, THE DELIVERY SYSTEM COULD NOT BE INSERTED DUE TO RESISTANCE. WHEN THE PHYSICIAN CHECKED THE TIP OF THE DELIVERY SYSTEM, THE BLACK PORTION AT THE TIP OF THE OUTER SHEATH WAS FOUND TO BE TURNED UP. THE PHYSICIAN PRESSED THE BLACK PORTION AT THE TIP OF THE OUTER SHEATH WITH HIS HAND TO ELIMINATE THE DEFORMATION AND THEN MADE A SLIGHTLY LARGER CUT IN THE FEMORAL ARTERY, WHICH ENABLED THE DELIVERY SYSTEM TO INSERT INTO THE ARTERY. WHEN RESISTANCE WAS FELT DURING INSERTION, THE PHYSICIAN DID NOT FORCE THE INSERTION BUT CONTINUED THE INSERTION SLOWLY WHILE CHECKING UNTIL THE DELIVERY SYSTEM SAFELY REACHED THE INTENDED POSITION. AFTER THAT, THE STENT-GRAFT WAS IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. WHEN THE REMOVED DEVICE WAS CHECKED, ANOTHER PORTION OTHER THAN THE TIP PRESSED BY THE PHYSICIAN WAS FOUND TO BE TURNED UP AS WELL, WHICH WAS PHOTOGRAPHED (SEE THE IMAGE). AS THE DEVICE HAD NOT HIT ANYWHERE AND THERE WAS NO PLACE WHERE RESISTANCE WOULD BE APPLIED DURING INSERTION, IT WAS ASSUMED THAT THE PORTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514802 ↗

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