RelayPro Thoracic Stent-Graft System 28-N4-32-104-32URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843576150461), received between Sep 19, 2024 and Aug 1, 2025 — classified as 2 deaths, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionAug 1, 2025Failure to Advance; Failure to Advance

  "THE SURGEON ATTEMPTED TO ADVANCE A 32X164 NBS RELAY PRO TO THE PROXIMAL LANDING ZONE. TORTUOUS DESCENDING AORTIC ANATOMY AND PROXIMAL ANGULAR GOTHIC ARCH ANATOMY APPEARED TO LIMIT THE DEVICE'S ABILITY TO REACH THE DESIRED LANDING ZONE. THE DEVICE WOULD NOT ADVANCE, AND THE WIRE WAS STUCK IN THE DELIVERY SYSTEM, (WOULD NOT ADVANCE OR RETRACT). THE SURGEON WAS FORCED TO REMOVE THE DEVICE. UPON INSPECTION THE PROXIMAL ASPECT OF THE DELIVERY SYSTEM WAS DAMAGED AT THE JUNCTION OF THE NOSE CONE AND DELIVERY SYSTEM. THE MID PORTION OF THE OUTER SHEATH WAS "ACCORDIONED", AS WAS THE DISTAL ASPECT OF THE OUTER SHEATH. THE STIFF WIRE WAS AGAIN ADVANCED JUST PROXIMAL TO THE AORTIC VALVE. A SECOND DEVICE WAS ATTEMPTED (32X104 NBS). SIMILAR RESULTS OCCURRED WITH SIGNIFICANT DAMAGE AGAIN OCCURRING TO THE DELIVERY SYSTEM. THE WIRE AGAIN WAS TRAPPED IN THE DELIVERY SYSTEM UNABLE TO RETRACT OR ADVANCE." PATIENT OUTCOME: "TEVAR COMPLETED WITH GORE CTAG PROXIMALLY AND A TERUMO AORTIC RELAYPRO EXTENDED DISTALLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22692175 ↗
• DeathSep 25, 2024Adverse Event Without Identified Device or Use Problem; Failure to Seal; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Failure to Seal; Device Endoleak

  "SUBJECT PRESENTED A PENETRATING AORTIC ULCER (PAU) AND WAS TREATED WITH RELAYPRO NBS ON (B)(6) 2024. SUBJECT WAS DISCHARGED TO AN OUTPATIENT FACILITY ON (B)(6) 2024 AND UNFORTUNATELY PASSED AWAY ON (B)(6) 2024; AN AUTOPSY WAS PERFORMED. PI HAS DECLARED THE DEATH UNDETERMINED IF RELATED TO PROCEDURE OR DEVICE. IMAGING HAS BEEN REQUESTED. AS PER DEATH DOCUMENTATION: CTA CHEST - AORTA: REDEMONSTRATION OF A PATIENT ENDOGRAFT REPAIR OF A PENETRATING DESCENDING THORACIC AORTIC ULCER/ANEURYSM. THERE IS NEW OPACIFICATION OF THE ANEURYSM SAC POSTERIOR TO THE ABDOMINAL AORTA CONCERNING FOR AN ENDOLEAK, LIKELY TYPE I OR TYPE IV. THE ANEURYSM SAC MEASURES UP TO 4.5 CM IN DIAMETER. THERE REMAINS SOME SURROUNDING HYPODENSITY THAT IS UNCHANGED COMPARED TO PRIOR FAVORED TO REPRESENT AN EVOLVING OLD BLOOD PRODUCTS." PATIENT OUTCOME: "PATIENT DEATH"

  Patient problems: Aneurysm expansion; Clinical Endoleak; Hemoptysis

  MAUDE report 20300886 ↗
• DeathSep 19, 2024Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  "AORTIC ANEURYSM RUPTURE: TEVAR WAS ATTEMPTED TO BE PERFORMED ON THE PATIENT WITH AN AORTIC ARCH ANEURYSM WITH THROMBUS, PLANNING TO PLACE THE STENT-GRAFTS IN ZONE 2 JUST BELOW THE LEFT COMMON CAROTID ARTERY (LCA). INITIALLY, A 28 MM-104 MM STENT-GRAFT WAS PLACED DISTALLY. NO RUPTURE OF THE ANEURYSM WAS OBSERVED AT THIS POINT. THE STENT GRAFT LANDED MORE DISTALLY THAN PLANNED, RESULTING IN THE PROXIMAL PORTION OF THE STENT GRAFT BEING PLACED WITHOUT PROPERLY APPOSED AGAINST THE ARCH CURVATURE. THE STENT GRAFT CONCERNED WAS THEN ATTEMPTED TO BE DELIVERED TO THE PLANNED IMPLANTATION SITE (JUST BELOW THE PROXIMAL ZONE2 AND DISTAL TO THE INITIAL STENT GRAFT). HOWEVER, DELIVERY OF THE STENT GRAFT WAS DIFFICULT, THE DELIVERY SYSTEM TIP STRESSED THE AORTIC ARCH ANEURYSM AND THE ANEURYSM RUPTURED DURING DELIVERY. DUE TO A SHARP DROP IN BLOOD PRESSURE, IMPLANTATION OF THE STENT GRAFT WAS ABORTED AND THE STENT GRAFT WAS REMOVED FROM THE PATIENT. A STENT-GRAFT (TAG 34 MM- 150 MM, GORE) WAS IMPLANTED. HOWEVER, BLOOD PRESSURE DID NOT RECOVER AFTER IMPLANTATION OF THE TAG STENT GRAFT AND ANGIOGRAPHY REVEALED A TYPE 2 ENDOLEAK 2 FROM THE LEFT SUBCLAVIAN ARTERY. PERCUTANEOUS CARDIOPULMONARY SUPPOR

  Patient problems: Great Vessel Perforation; Rupture

  MAUDE report 20262814 ↗

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