RelayPro Thoracic Stent-Graft System 28-N4-40-204-40URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843576150768), received between Feb 24, 2025 and Oct 31, 2025 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Device Endoleak” (3 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.

• DeathOct 31, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  "SUBJECT PRESENTED A CHRONIC AORTIC DISSECTION, DEBAKEY TYPE III STANFORD TYPE B. ONE RELAY PRO NBS WAS USED DURING INDEX PROCEDURE. SITE RECEIVED AN ALERT THROUGH THEIR EPIC SYSTEM THAT THE PATIENT IS DECEASED AS OF (B)(6) 2024, BUT THERE IS NO DOCUMENTATION. THERE IS NO FURTHER INFORMATION IN THE PATIENT'S CHART, OUTSIDE FACILITIES, OR OBITUARY. SITE HAS TRIED CONTACTING THE PCP ON FILE, BUT THEY DO NOT HAVE ANY RECORD OF THE PATIENT. THEIR EMERGENCY CONTACT NUMBER IS OUT OF SERVICE." PATIENT OUTCOME: "DECEASED".

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 23441247 ↗
• InjuryAug 27, 2025Device Endoleak; Device Endoleak

  "ON (B)(6) 2025 SUBJECT PRESENTED A CHRONIC DISSECTION; DETAILS OF THE PROCEDURE ARE STILL PENDING FROM THE SITE, HOWEVER, THE SITE DID REPORT A TYPE IIIA ENDOLEAK CONFIRMED BY CT AT INDEX PROCEDURE; SITE REPORTED THIS AS RELATED TO PROCEDURE AND DEVICE. PRIOR TO THE PROCEDURE THE SITE STATED THAT THE SUBJECT HAD AN ACUTE ON CHRONIC DISSECTION INVOLVING JUXTA SUPERIOR MESENTERIC ARTERY AORTA EXTENDING DISTALLY INTO RIGHT EXTERNAL ILIAC ARTERY AND INTO DISTAL SUPERIOR MESENTERIC ARTERY. FOLLOWING THE INDEX PROCEDURE, THE SITE REPORTED THAT THE PATIENT DEVELOPED A SMALL ILEUS ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE), CT SCAN SHOWED AN INTRAMURAL HEMATOMA ALONG THE AORTIC ARCH ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE), CT SCAN SHOWED A LEFT PLEURAL EFFUSION WITH COMPRESSIVE ATELECTASIS OF THE LINGULA AND LEFT LOWER LOBE ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE), CT SCAN SHOWED A TREOPERITONEAL AND PELVIC HEMATOMA ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE) AND SIGNIFICANT POST-OP PAIN ((B)(6) 2025 - REPORTED AS RELATED TO PROCEDURE)." PATIENT OUTCOME: "PENDING COMPLETION OF DATA ENTRY AND SITE WAS ASKED TO UPLOAD ALL IMAGING AND PROVIDE SOURCE DOCUMENTATION.

  Patient problems: Clinical Endoleak

  MAUDE report 22907391 ↗
• InjuryApr 14, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "ENDOLEAK (TYPE IA): THE RELAY PRO STENT GRAFT WAS PLANNED TO BE PLACED OVER HALF OF THE LSA AGAINST A STEEP ARCH. AS THE DELIVERY SYSTEM PASSED THROUGH THE ARCH, THE DELIVERY SYSTEM TOOK A SHORTCUT, ADVANCING THE INNER SIDE OF THE ARCH, RESULTING IN INSUFFICIENT DEPLOYMENT AND CREATING SPACE ON THE OUTER SIDE OF THE ARCH. THE LOCATION OF THE STENT GRAFT ON THE OUTER SIDE OF THE ARCH WAS MIGRATED AND A TYPE 1A ENDOLEAK OCCURRED ON FINAL ANGIOGRAPHY. SINCE A RELAY PRO STENT GRAFT (28-N4-38-199-38U) HAD ALREADY BEEN IMPLANTED PERIPHERALLY, THERE WAS NOTHING MORE THAN THAT COULD BE DONE, AND THE PROCEDURE WAS COMPLETED. FURTHER INTERVENTION WILL BE CONSIDERED AT A LATER DATE WHILE THE PATIENT IS MONITORED. OPERATION TYPE: STENT GRAFT IMPLANTATION. NO BLOOD LOSS. ANCILLARY DEVICE USED: 28-N4-38-199-38U. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE. ADDITIONAL INFORMATION WILL BE OBTAINED. (TC#(B)(4))". PATIENT OUTCOME: "THE PATIENT IS UNDER OBSERVATION."

  Patient problems: Clinical Endoleak

  MAUDE report 21835233 ↗
• InjuryFeb 24, 2025Device Endoleak; Device Endoleak

  "ENDOLEAK (TYPE IIIA): ON (B)(6), THE RELAY PRO STENT GRAFT AND A DISTAL EXTENSION GRAFT (30 MM, COOKMEDICAL) WERE IMPLANTED IN A TEVAR CASE. ON, (B)(6), A FOLLOW-UP CT SCAN SHOWED CONTRAST ENTERING THE ANEURYSM AND IT WAS DETERMINED TO BE A TYPE IIIA ENDOLEAK. THE PATIENT IS SCHEDULED TO UNDERGO EVAR ON (B)(6), AT WHICH TIME AN ADDITIONAL TEVAR WILL BE PERFORMED. AN ADDITIONAL TOUCH-UP WITH BALLOON WILL BE PERFORMED AT THE SITE OF SUSPECTED A TYPE IIIA ENDOLEAK AND AN ADDITIONAL CUFF WILL BE IMPLANTED. OPERATION TYPE: TEVAR. NO BLOOD LOSS. ANCILLARY DEVICE USED: DISTAL EXTENSION GRAFT (30 MM, COOKMEDICAL). 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: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: Clinical Endoleak

  MAUDE report 21451963 ↗

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