RelayPro Thoracic Stent-Graft System 28-N4-36-154-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843576150614), received between Jan 27, 2025 and Sep 2, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Ejection Problem; Difficult or Delayed Separation; Ejection Problem; Difficult or Delayed Separation

  "UNABLE TO DEPLOY THE STENT GRAFT: THE RELAY PRO STENT-GRAFT (NBS) WAS ATTEMPTED TO BE IMPLANTED. THE BLACK APEX HOLDER KNOB WAS ATTEMPTED TO BE PULLED WITH THE CONTROLLER IN THE "3", BUT IT WAS TOO STIFF TO MOVE THE APEX HOLDER KNOB. THE PROBLEM WAS SOLVED BY DESTROYING THE STAINLESS STEEL ROD USING PLIERS AND PULLING THE GREEN TUBE THAT WAS INSIDE. THE STENT-GRAFT WAS DEPLOYED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR BLOOD LOSS: UNKNOWN. IMAGE WILL BE ABLE TO BE OBTAINED PRE-CASE PLAN WILL BE ABLE TO BE OBTAINED ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED. (TC#(B)(4)). PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22944692 ↗
• MalfunctionJun 30, 2025Ejection Problem; Difficult or Delayed Separation; Ejection Problem; Difficult or Delayed Separation

  "UNABLE TO DEPLOY THE STENT GRAFT / DELIVERY SYSTEM FAILURE: TWO STENT GRAFTS WERE PLANNED TO BE STACKED AND IMPLANTED FROM THE PERIPHERY. THE RELAY PRO, WHICH WAS TO BE IMPLANTED PROXIMALLY, WAS ATTEMPTED TO BE IMPLANTED, BUT THE BLACK APEX HOLDER KNOB (MARKED "3") COULD NOT BE PULLED TOWARD THE GRAY GUIDEWIRE LUER. THIS PREVENTED THE PROXIMAL END OF THE STENT GRAFT FROM BEING RELEASED. AFTER ATTEMPTING SEVERAL BAILOUT TECHNIQUES, THE BLACK APEX HOLDER KNOB COULD BE PULLED, AND THE STENT GRAFT WAS RELEASED. HOWEVER, DISTORTION WAS OBSERVED IN THE STAINLESS STEEL ROD. OPERATION TYPE: TEVAR BLOOD LOSS: UNKNOWN. ANCILLARY DEVICES USED: LUNDERQUIST (COOK MEDIAL), DRYSEAL (GORE), PIGTAIL SIZING CATHETER (MANUFACTURER UNKNOWN) ANCILLARY MEDICATIONS: HEPARIN, CONTRAST MEDIA. IMAGE AVAILABLE UPON REQUEST PRE-CASE PLAN AVAILABLE UPON REQUEST ADDITIONAL INFORMATION AVAILABLE UPON REQUEST. ((B)(4). PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366570 ↗
• MalfunctionJun 27, 2025Failure to Advance; Failure to Advance

  "UNABLE TO ADVANCE THE INNER SHEATH: AFTER IMPLANTATION OF A THORAFLEX HYBRID ON (B)(6) 2025, A TWO-STAGED TEVAR WAS PERFORMED USING THE RELAYPRO ON (B)(6). DURING AN ATTEMPT TO ADVANCE THE RELAYPRO INTO THE THORAFLEX HYBRID, THE INNER SHEATH COULD NOT BE ADVANCED. THEREFORE, THE ENTIRE THE DELIVERY SYSTEM WAS ADVANCED INSTEAD. HOWEVER, A MIGRATION OF THE THORAFLEX HYBRID OCCURRED, MAKING ADVANCEMENT OF THE RELAYPRO DIFFICULT. SEVERAL ATTEMPTS WERE MADE, BUT THE RELAYPRO COULD NOT REACH THE LANDING POSITION. THEN, THE INNER SHEATH UNINTENTIONALLY MOVED PROXIMALLY, CAUSING ONE STENT TO BE EXPOSED FROM THE INNER SHEATH AND ALMOST DEPLOYED. THE STENT GRAFT AND INNER SHEATH WERE RETRACTED INTO THE OUTER SHEATH AND A DRYSEAL (GORE) AS FAR AS POSSIBLE, AND THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. AFTER REMOVING THE RELAYPRO, A COMPETITOR'S DEVICE WAS URGENTLY PREPARED AND IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT WAS RETURNED TO THE WARD. OPERATION TYPE: TEVAR, BLOOD LOSS: UNKNOWN, ANCILLARY DEVICES: TAG (GORE), DRYSEAL (GORE) . IMAGE AVAILABLE UPON REQUEST, PRE-CASE PLAN AVAILABLE UPON REQUEST, ADDITIONAL INFORMATION AVAILABLE UPON REQUEST, DELIVERY S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349995 ↗
• InjuryJan 27, 2025Obstruction of Flow; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Obstruction of Flow; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  "IS THIS EVENT RELATED TO DEVICE FAILURE / DEFICIENCY? POSSIBLY IS THIS EVENT RELATED TO THE PROCEDURE? NO IS THIS EVENT RELATED TO A PRE-EXISTING CONDITION? NO WAS SURGICAL INTERVENTION REQUIRED. ADMITTED TO OUTSIDE HOSPITAL ON (B)(6) 2024 WITH LEFT SIDED HEMIPLEGIA AND SENSORY CHANGE. PATIENT WAS TREATED WITH MECHANICAL THROMBECTOMY ON (B)(6) 2024 AND WAS FOUND TO HAVE THROMBUS AT THE BRANCH OF RIGHT INNOMINATE ARTERY. INVESTIGATOR ASSESSMENT OF POSSIBLY RELATED TO DEVICE, UNDETERMINED IF RELATED TO THORAFLEX HYBRID OR RELAYPRO NBS SPECIFICALLY. PREVIOUS ADVERSE EVENT OF ANEURYSM EXPANSION, DYSPHONIA AND RIGHT VENT DYSFUNCTION." PATIENT OUTCOME: "RESOLVED (B)(6) 2024 - REMAINS IN STUDY FOLLOW UP."

  Patient problems: Paraplegia; Thrombosis/Thrombus

  MAUDE report 21242933 ↗

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