RelayPro Thoracic Stent-Graft System 28-N4-32-209-28URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576151055), received between Feb 12, 2025 and Apr 30, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathApr 30, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  "DEATH: ON (B)(6), AN EMERGENCY TEVAR WAS PERFORMED FOR AN AORTIC DISSECTION. THE RELAY PRO STENT GRAFT CONCERNED (28-N4-32-209-28U, LOT#: 2404170130) WAS IMPLANTED CENTRALLY AND A RELAY PRO STENT GRAFT (28-N4-32-164-28U, LOT#: 2407130037) WAS ADDITIONALLY IMPLANTED PERIPHERALLY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS WITH THE PROCEDURE OR THE DEVICES THEMSELVES. ON (B)(6), THE PATIENT'S CONDITION SUDDENLY CHANGED, AND THE PATIENT DIED. AFTER DEATH, A CT SCAN REVEALED THAT THE INTERNAL PRESSURE IN THE FALSE LUMEN HAD INCREASED DUE TO THE EXPANSION OF THE TRUE LUMEN CAUSED BY THE IMPLANTATION OF THE STENT GRAFTS, AND THE FALSE LUMEN HAD RUPTURED AROUND THE ABDOMEN. PHYSICIAN'S COMMENT: THE PHYSICIAN DID THE BEST THAT HE COULD WITH THE MEANS AVAILABLE TO THE HOSPITAL. THERE WAS NO OTHER CHOICE. PHYSICIAN'S COMMENT ON CAUSAL RELATIONSHIP: THE MEANS TAKEN FOR THE AORTIC DISSECTION WERE THE BEST, GIVEN THE EMERGENCY TREATMENT ON (B)(6), BUT THE TRUE LUMEN EXPANDED MORE THAN EXPECTED. OPERATION TYPE: EMERGENCY TEVAR FOR AN AORTIC DISSECTION, NO BLOOD LOSS, ANCILLARY DEVICE USED: 28-N4-32-164-28U (LOT#: 2407130037), NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY, NO PRE-CASE PLAN AVA

  Patient problems: Reduced Blood Flow; Vascular Dissection

  MAUDE report 21935240 ↗
• MalfunctionFeb 12, 2025Mechanical Problem; Failure to Advance; Difficult to Advance; Mechanical Problem; Failure to Advance; Difficult to Advance

  "WE ADVANCED THE INNER SHEATH IN POSITION ONE USING THE MECHANICAL ADVANTAGE, THE DISENGAGEMENT BUTTON WAS PRESSED AND THE MECHANICAL ADVANTAGE HANDLE ADVANCED FORWARD TO REMOVE THE INNER SHEATH AND DEVICE FROM THE OUTER SHEATH. THE MECHANICAL ADVANTAGE WAS ADVANCED AS FAR AS IT COULD GO, HOWEVER, THE DISTAL 15MM OF THE DEVICE WAS STILL INSIDE THE OUTER SHEATH. WE TRIED TURNING THE MECHANICAL ADVANTAGE TO ADVANCE THE DEVICE THE REST OF THE WAY, BUT IT WOULD NOT ADVANCE AND REMAINED INSIDE THE OUTER SHEATH. WE PULLED AND ADVANCED THE ENTIRE DELIVERY SYSTEM AND THAT ALLOWED THE DEVICE TO EXIT THE OUTER SHEATH, BUT ONLY BY A COUPLE MM'S. AT THAT POINT, WE WENT TURNED TO POSITION TWO, IT TOOK SEVERAL TURNS BEFORE THE INNER SHEATH BEGAN TO MOVE AND DEPLOY THE DEVICE. WHEN IT DID START TO MOVE, IT QUICKLY OPENED THE PROXIMAL END OF THE DEVICE. WE FULLY DEPLOYED THE REST OF THE DEVICE AND POSITION 3 AND 4 OPERATED NORMALLY." PATIENT OUTCOME : "NO CONSEQUENCE TO PATIENT, DEVICE STILL DEPLOYED IN THE INTENDED LOCATION. "

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370604 ↗

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