RelayPro Thoracic Stent-Graft System 28-M4-38-145-34URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150164), received between May 15, 2026 and May 15, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 20, 2022Class IIOpen, Classified

   The product may be shorter than packaging indicates

   Z-0997-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

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.

• MalfunctionMay 15, 2026Failure to Advance; Unintended Movement

  "BROKEN: THE RELAY PRO STENT GRAFT WAS USED FOR ONE-DEBRANCHING TEVAR. AFTER CONSTRUCTING THE DEBRANCH, THE DELIVERY SYSTEM WAS INSERTED THROUGH THE RIGHT COMMON FEMORAL ARTERY AND ADVANCED TO THE LEVEL OF THE AORTIC VALVE. AFTER ENSURING THAT THE CONTROLLER WAS IN THE "1" POSITION, THE DEPLOYMENT GRIP WAS ROTATED CLOCKWISE. THE PHYSICIAN FELT SOMETHING UNUSUAL BECAUSE HE HEARD A CRACKING SOUND AT THE BEGINNING OF THE ROTATION, BUT HE CONTINUED TO ROTATE THE GRIP. THE INNER SHEATH WAS ADVANCED UNTIL THE DEPLOYMENT GRIP ASSEMBLY PASSED THE WHITE ARROW MARKER WITH THE CONTROLLER IN THE "1" POSITION. HOWEVER, UNDER FLUOROSCOPY, THE INNER SHEATH DID NOT APPEAR TO ADVANCE OUT OF THE OUTER SHEATH TIP. UPON LOOKING AT THE COMMON FEMORAL ARTERY, THE PHYSICIAN FOUND THAT THE OUTER SHEATH HAD DETACHED FROM THE HANDLE BODY. THEREFORE, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. ANOTHER RELAY PRO STENT GRAFT WITH THE SAME SPECIFICATIONS (AR-B3814534, LOT#2503110143) WAS INSERTED. THE STENT GRAFT WAS DEPLOYED AND IMPLANTED WITHOUT ISSUE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PHYSICIAN COMMENTED THAT THE OUTER SHEATH COULD NOT HAVE PROPERLY FIT WITH THE HANDLE BODY. O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25192082 ↗

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