RelayPro Thoracic Stent-Graft System 28-N4-32-164-28URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843576150959), received between Apr 30, 2025 and Dec 23, 2025 — classified as 1 death, 2 injuries, 1 malfunction.

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

• InjuryDec 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  "DISSECTION: ON (B)(6) 2025, THE RELAY PRO STENT-GRAFT (NBS) WAS IMPLANTED FOR EMERGENCY TYPE B DISSECTION. ALTHOUGH THE PATIENT HAD NO SYMPTOMS AFTER THE PROCEDURE, FOLLOW-UP CONTRAST-ENHANCED CT ON (B)(6) REVEALED RETROGRADE TYPE A AORTIC DISSECTION (RTAD) WITH AN ENTRY AT THE LESSER CURVATURE AROUND THE PROXIMAL END OF THE STENT-GRAFT. EMERGENCY TAR-FET USING A FROZENIX (JAPAN LIFELINE) WAS THEN PERFORMED. PHYSICIAN'S COMMENT: AS THE STENT-GRAFT IS NOT OVERSIZED FOR THE NATIVE VESSEL, THE PHYSICIAN DOES NOT KNOWN WHY RTAD OCCURRED. 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 (TC#(B)(4))" PATIENT OUTCOME: "HEALTH DAMAGE TO THE PATIENT IS UNKNOWN."

  Patient problems: Vascular Dissection

  MAUDE report 23884489 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "ON POST OPERATIVE DAY 8 (B)(6) 2025), SITE REPORTED AN ADVERSE EVENT (AE) OF NON-OCCLUSIVE LEFT SUBCLAVIAN ARTERY THROMBUS - FURTHER COMMENTS DETAIL "NEW NON-OCCLUSIVE THROMBUS PRESENT AT THE LEFT SUBCLAVIAN ARTERY ON (B)(6) 2025) CTA. DUAL ANTIPLATELET THERAPY CONTINUED. CONCOMITANT MEDICATIONS INCLUDE ASPIRIN, ATORVASTATIN, HEPARIN, HYDRALAZINE, LABETALOL, AMIODARONE, NOREPINEPHRINE, EPINEPHRINE, METOPROLOL TARTRATE, NICARDIPINE, NITROPRUSSIDE, CLEVIDIPINE, ESMOLOL, NITROGLYCERIN, CLOPIDOGREL AND LOSARTAN. THE INVESTIGATOR CONSIDERS THE AE AS ANTICIPATED, RELATED TO PROCEDURE, NOT RELATED TO DEVICE, NOT RELATED TO DEVICE DEFICIENCY AND NOT RELATED TO A PRE-EXISTING CONDITION. THE AE WAS CONSIDERED MILD IN SEVERITY." PATIENT OUTCOME: "AT TIME OF REPORTING, THE EVENT IS STILL ONGOING, WITH CURRENT STATUS UNRESOLVED STILL TREATING. SUBJECT CONTINUES ON THE STUDY."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22482591 ↗
• MalfunctionJun 20, 2025Activation, Positioning or Separation Problem; Difficult to Advance; Activation, Positioning or Separation Problem; Difficult to Advance

  "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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301447 ↗
• 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 APRIL 14, 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 A

  Patient problems: Reduced Blood Flow; Vascular Dissection

  MAUDE report 21935239 ↗

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