RelayPro Thoracic Stent-Graft System 28-M4-30-200-26URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150225), received between Nov 7, 2025 and Nov 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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.

• MalfunctionNov 7, 2025Difficult to Advance; Difficult or Delayed Separation; Difficult to Advance; Difficult or Delayed Separation

  "UNABLE TO ADVANCE THE INNER SHEATH / DIFFICULT TO RETRACT THE OUTER SHEATH: THE RELAYPRO WAS USED FOR AN ADDITIONAL TEVAR ON A FET. WHEN ATTEMPTING TO ADVANCE THE INNER SHEATH IN THE FET BY ROTATING THE DEPLOYMENT GRIP WITH THE CONTROLLER IN POSITION 1, THE INNER SHEATH DID NOT ADVANCE. AFTER ADVANCING THE OUTER SHEATH TO A CERTAIN POINT, THE OUTER SHEATH WAS ATTEMPTED TO BE RETRACTED BY PRESSING THE DISENGAGEMENT BUTTON, BUT IT WAS VERY STIFF AND DIFFICULT TO RETRACT. THE OUTER SHEATH WAS FORCIBLY RETRACTED, AND THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED. PHYSICIAN'S COMMENT: THE OUTER SHEATH COULD BE RETRACTED WITH FORCE, BUT THERE WAS A POSSIBILITY THAT THE DEPLOYMENT OF THE STENT GRAFT COULD FAIL. 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. DELIVERY SYSTEM WAS DISCARDED BY USER. (TC#(B)(4))". PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501400 ↗

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