RelayPro Thoracic Stent-Graft System 28-M4-34-145-30URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150140), received between Oct 3, 2024 and Oct 30, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Endoleak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Separation Failure; Failure to Eject; Difficult or Delayed Separation; Separation Failure; Failure to Eject; Difficult or Delayed Separation

  "APEX HOLDER COULD NOT BE PULLED/DELIVERY SYSTEM TIP, APEX HOLDER AND OUTER CONTROL TUBE WERE LEFT IN THE PATIENT/DISSECTION: BACKGROUND OF THE PATIENT: TWO VALIANT (APPROX. SIZE 34, MEDTRONIC) WERE IMPLANTED CENTRALLY AND THE RELAYPRO WAS TO BE IMPLANTED PERIPHERALLY TO THE VALIANT DEVICES. THERE WAS A SEVERE CURVATURE IN THE TARGET VESSEL. IMPLANTATION PLAN: -THE RELAY PRO (28-M4-34-145-30U) WAS TO BE IMPLANTED USING THE PULL-THROUGH TECHNIQUE. -WITHOUT PLACING THE OUTER SHEATH AT THE VESSEL CURVATURE TO AVOID DAMAGE FROM THE TIP OF THE OUTER SHEATH, THE INNER SHEATH WAS TO BE ADVANCED GRADUALLY FROM THE PROXIMAL TO THE CURVATURE TO ADVANCE THE DELIVERY SYSTEM UNDER THE CONTROL OF A GUIDEWIRE FOR THE PULL-THROUGH TECHNIQUE. IMPLANTATION: AS PER THE ABOVE PLAN, THE DELIVERY SYSTEM COULD BE ADVANCED TO THE TARGET LANDING ZONE BY CONTROLLING THE GUIDEWIRE FOR THE PULL-THROUGH TECHNIQUE. RELEASE OF THE STENT GRAFT: -THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED WITH THE CONTROLLER IN POSITION 2. -TO RELEASE THE BARE STENT OF THE STENT GRAFT BY PULLING THE APEX HOLDER (INDICATING 3), THE APEX HOLDER WAS ATTEMPTED TO BE PULLED BUT COULD NOT BE PULLED. THE APEX HOLDER WAS PULLED FORCEFULLY

  Patient problems: Perforation of Vessels

  MAUDE report 20565974 ↗
• InjuryOct 3, 2024Device Endoleak; Device Endoleak

  "ENDOLEAK (TYPE UNKNOWN): THE RELAYPRO STENT-GRAFT WAS IMPLANTED FROM ZONE 2. THE FINAL ANGIOGRAPHY CONFIRMED NO LEAKAGE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER THAT, HOWEVER, CONTRAST-ENHANCED CT REVEALED AN ENDOLEAK (TYPE UNKNOWN). ON (B)(6) 2024, ADDITIONAL TEVAR WAS PERFORMED. A RELAYPRO (28-M4-34-145-30U), WHICH HAS COMPLETELY DIFFERENT SPECIFICATIONS, WAS IMPLANTED OVER THE STENT-GRAFT CONCERNED THAT HAD ALREADY BEEN IMPLANTED. THE PHYSICIAN DETERMINED THAT THE ENDOLEAK HAD DISAPPEARED, AND 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 - "HEALTH DAMAGE TO THE PATIENT IS UNKNOWN."

  Patient problems: Clinical Endoleak

  MAUDE report 20363476 ↗

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