RelayPro Thoracic Stent-Graft System 28-M4-40-250-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150379), received between Jan 29, 2025 and Jan 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult 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.

• MalfunctionJan 29, 2025Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  "TYPE OF PROCEDURE PERFORMED: TEVAR. WHILE DEPLOYING THE DOCTOR NEVER CAME OUT OF POSITION #1. LANDED SHORT AND PROCEEDED TO TURN THE DEPLOYMENT KNOB TO ADVANCE THE INNER SHEATH. WAS RESPONDING BUT NOT GREAT. IT WAS STILL SOMEWHAT IN THE OUTER SHEATH BUT STILL NEEDED TO BE ADVANCED TO GET TO TARGET AT THE LSA. THE DOCTOR PUSHED ENTIRE SYSTEM AS A UNIT TO THE TARGET AREA WITH MINIMAL EFFORT. WE NOTICED THAT THE OUTER SHEATH WAS MORE THAN 3/4 COVERING THE IMPLANT WHICH WAS STILL IN THE INNER SHEATH AND NOT DEPLOYED YET. WE THOUGHT TO REVERSE DEPLOY BUT THE WAS REALLY NO ROOM FOR THIS AS THE MECHANICAL ADV WAS HUBBED AGAINST THE CONTROLLER AND THE OUTER SHEATH WAS HUBBED ON THE PATIENT. WHEN LOOKING IN THE MAIN BODY CHANNEL IT APPEARED THAT EVERYTHING WAS JAMMED UP. WE DECIDED TO REMOVE THE ENTIRE UNIT WHICH WAS UN-EVENTFUL AND OPEN THE BACKUP (WHICH WAS NBS, NOT THE BARE) AND THE PROCEDURE WAS PERFECT AFTER THAT. PATIENT IDENTIFIER: (B)(6). PATIENT OUTCOME: "THERE WAS NO HARM, THE PATIENT IS STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264943 ↗

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