RelayPro Thoracic Stent-Graft System 28-N4-34-154-30URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843576150966), received between Jun 20, 2025 and Dec 26, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Endoleak” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall 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. Apr 22, 2026Class IOpen, Classified

   Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

   Z-2160-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 20, 2022Class IIOpen, Classified

   The product may be shorter than packaging indicates

   Z-0998-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Device Endoleak; Device Endoleak

  "ENDOLEAK: TEVAR USING THE RELAY PRO STENT-GRAFT WAS PERFORMED ON (B)(6) 2024. THE PATIENT HAD NO PROBLEMS AFTER THE PROCEDURE. HOWEVER, A FOLLOW-UP CT SCAN THAT WAS PERFORMED A YEAR AFTER THE PROCEDURE REVEALED THE ENLARGEMENT OF THE ANEURYSM. THE TYPE OF ENDOLEAK IS UNKNOWN, BUT THE PHYSICIAN SUSPECTS IT IS TYPE 3B. OPERATION TYPE: TEVAR (ZONE 3) NO BLOOD LOSS. IMAGE AVAILABLE (WE RECEIVED A POSTOPERATIVE CT SCAN. DUE TO ITS LARGE FILE SIZE, KOGA-SAN WILL SHARE THE IMAGE VIA A FILE-SHARING SERVICE.) PRE-CASE PLAN AVAILABLE UPON REQUEST NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. (TC#(B)(4). PATIENT OUTCOME: "NO DAMAGE TO THE PATIENT'S HEALTH."

  Patient problems: Clinical Endoleak

  MAUDE report 23898635 ↗
• MalfunctionJul 23, 2025Retraction Problem; Difficult to Advance; Difficult or Delayed Separation; Retraction Problem; Difficult to Advance; Difficult or Delayed Separation

  "UNABLE TO ADVANCE THE INNER SHEATH / UNABLE TO DEPLOY THE STENT GRAFT: AFTER THE LEFT SUBCLAVIAN-TO-LEFT COMMON CAROTID ARTERY BYPASS, TEVAR WAS PERFORMED. THE PLAN WAS TO IMPLANT THE RELAY PRO STENT GRAFT CONCERNED PERIPHERALLY AND A NAJUTA STENT GRAFT (SB-KAWASUMI) CENTRALLY. AFTER INSERTING A DRY SEAL SHEATH (22FR, GORE) INTO THE RIGHT LEG, THE RELAY PRO STENT GRAFT WAS DELIVERED OVER AN EGOIST GUIDEWIRE (ARCH-CURVE, MEDICOS HIRATA). WHEN DEPLOYMENT WAS STARTED WITH THE CONTROLLER IN THE "1" POSITION, IT WAS OBSERVED THAT THE OUTER SHEATH MOVED DOWN WITHOUT THE INNER SHEATH ADVANCING. THEREFORE, THE ENTIRE DELIVERY SYSTEM WAS ADVANCED TO THE INTENDED DEPLOYMENT SITE. THE STENT GRAFT WAS POSITIONED IN ZONE 2 AND THE CONTROLLER WAS TURNED TO THE "2" POSITION TO DEPLOY THE ENTIRE STENT GRAFT. THE APEX HOLDER KNOB WAS THEN ROTATED AND SLID PROPERLY TOWARD THE GRAY GUIDEWIRE LUER IN AN ATTEMPT TO RELEASE THE STENT GRAFT FROM THE APEX HOLDER. HOWEVER, EVEN THOUGH THE APEX HOLDER KNOB WAS SLID ALL THE WAY, THE KNOB RETURNED AS IF PULLING A RUBBER BAND, PREVENTING THE STENT GRAFT FROM BEING DEPLOYED. THEN, THE CONTROLLER WAS TURNED TO THE "1" POSITION, AND THE STENT GRAFT WAS ATTEMPTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580794 ↗
• InjuryJun 20, 2025Activation, Positioning or Separation Problem; Difficult to Advance; Device Endoleak; Activation, Positioning or Separation Problem; Difficult to Advance; Device Endoleak

  "UNABLE TO ADVANCE THE INNER SHEATH / UNABLE TO DEPLOY / ENDOLEAK (TYPE UNKNOWN): THE DAY BEFORE THE PROCEDURE, THE PHYSICIAN INFORMED THE SALES REPRESENTATIVE THAT A SEMI-EMERGENCY TEVAR WOULD BE PERFORMED. AFTER DEVICES SPECIFIED BY THE PHYSICIAN WERE PREPARED, A PREOPERATIVE MEETING WAS HELD ON THE DAY OF THE PROCEDURE, AND THE PROCEDURE WAS PERFORMED. TO TREAT TYPE B DISSECTION, RELAY PRO STENT-GRAFTS WERE TO BE PLACED TO CLOSE HALF OF THE LEFT SUBCLAVIAN ARTERY (LSA) AS THE ENTRY WAS LOCATED SLIGHTLY DISTAL TO THE LSA. THE RIGHT FEMORAL ARTERY WAS PUNCTURED. AFTER A DISTANCE OF 150 MM FROM THE LSA WAS MEASURED, A RELAY PRO STENT-GRAFT (28-N4-24-099-24U) WAS FIRST IMPLANTED, AND THE STENT-GRAFT CONCERNED (28-N4-32-164-28U) WAS THEN INSERTED. THE PHYSICIAN ROTATED THE HANDLE TO ADVANCE THE INNER SHEATH WITH THE CONTROLLER IN THE "1" POSITION, BUT THE PHYSICIAN NOTICED THAT THE INNER SHEATH DID NOT ADVANCE EVEN AFTER THE HANDLE WAS ROTATED FOR A WHILE AND FELT THAT SOMETHING WAS WRONG WITH THE DEVICE. THE PHYSICIAN WAS CONCERNED ABOUT THE DEVICE CONCERNED AND UNPACKED ANOTHER RELAY PRO STENT-GRAFT (28-N4-34-154-30U) AS A REPLACEMENT IN THE FIELD OF OPERATION. WHEN THE PHYSICIAN A

  Patient problems: Clinical Endoleak; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301448 ↗

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-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