RelayPro Thoracic Stent-Graft System 28-N4-30-209-26URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843576151048), received between Dec 5, 2024 and Oct 29, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Seal” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls 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. 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.

• InjuryOct 29, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE DEVICE. AS INDICATED IN THE NARRATIVE, THE PRE-CASE PLAN, PRE/POST CT IMAGING, AND ADDITIONAL INFORMATION WERE NOT AVAILABLE DUE TO HOSPITAL POLICY. THE PATIENT UNDERWENT A TEVAR PROCEDURE TO TREAT A THORACIC ANEURYSM WITH A RELAY PRO NBS DEVICE (28-N4-30-209-26U). THERE WERE NO ISSUES REPORTED DURING ADVANCEMENT AND DEPLOYMENT OF THE IMPLANTED DEVICE. A TYPE IA ENDOLEAK WAS REVEALED AT THE 6-MONTH FOLLOW-UP. WITHOUT THE IMAGING FOR EVALUATION, THE ASSESSMENT OF THE ANATOMY, VERIFICATION OF THE CORRECT SIZING, GRAFT SELECTION, AND POSITIONING OF THE STENT-GRAFT COULD NOT BE CONFIRMED. THE TYPE IA ENDOLEAK COULD NOT BE CONFIRMED; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED." PATIENT OUTCOME: "REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WITH THE MANUFACTURE OF THE DEVICE. WITH THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED FAILURE OF TYPE IA ENDOLEAK COULD NOT BE DETERMINED. ENDOLEAKS ARE KNOWN ADVERSE EVENTS OF TEVAR PROCEDURES."

  Patient problems: Clinical Endoleak

  MAUDE report 23417523 ↗
• InjuryMay 22, 2025Patient Device Interaction Problem; Failure to Seal; Patient Device Interaction Problem; Failure to Seal

  "DISTAL SINE AND PROXIMAL SINE (SUSPECTED) / COAGULOPATHY / DIC/ LOWER LIMB ISCHEMIA: THE PATIENT DEVELOPED DSINE AND PSINE (SUSPECTED) AFTER WE REPORTED THE CEREBRAL INFARCTION UNDER #(B)(4). THE EFFECTS OF CEREBRAL INFARCTION HAVE LESSENED SINCE THE PREVIOUS REPORT. THE PATIENT FELL IN THE COURSE OF HIS/HER NORMAL ACTIVITIES AND A CT WAS TAKEN AT THE HOSPITAL ON (B)(6) 2024, WHICH SHOWED DSINE. ALTHOUGH THE CENTRAL SIDE ALSO APPEARED TO BE DISSECTED, IT WAS DETERMINED THAT NO TREATMENT WAS NECESSARY. ALTHOUGH THE PATIENT HAS DSINE, THE ISCHEMIA TO THE LOWER LIMBS HAS NOT DEVELOPED MUCH SO FAR, THE PROCEDURE WILL BE PERFORMED ON MAY 9 TO IMPLANT A DEVICE FOR TEVAR ON THE PERIPHERAL SIDE, SLIGHTLY ABOVE THE CELIAC ARTERY INSTEAD OF AN EMERGENCY PROCEDURE. PHYSICIAN'S COMMENT: COAGULOPATHY, DIC, AND LOWER LIMB ISCHEMIA DEVELOPED. OPERATION TYPE: TEVAR. BLOOD LOSS: AMOUNT IS UNKNOWN. IMAGE AVAILABLE UPON REQUEST. PRE-CASE PLAN AVAILABLE: SCHEMA ATTACHED. ADDITIONAL INFORMATION AVAILABLE UPON REQUEST. (TC# (B)(4))". PATIENT OUTCOME: "THERE WAS MINOR HEALTH DAMAGE TO THE PATIENT. THE PATIENT IS SCHEDULED FOR PROCEDURE."

  Patient problems: Vascular Dissection

  MAUDE report 22073580 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Patient Device Interaction Problem

  "DISTAL STENT GRAFT-INDUCED NEW ENTRY (DSINE): THE STENT-GRAFT WAS PLACED ON (B)(6) 2023. THERE WAS NO ENDOLEAK INTRAOPERATIVELY, AND POSTOPERATIVE CT SCAN SHOWED NO PROBLEMS. HOWEVER, A FOLLOW-UP CT SCAN PERFORMED ON (B)(6) 2025, REVEALED DSINE. AN ADDITIONAL TEVAR IS PLANNED FOR (B)(6) (DATE TO BE DETERMINED). 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. DELIVERY SYSTEM WAS DISCARDED BY USER. (TC#(B)(4))". PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH."

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 21953925 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  "CEREBRAL INFARCTION: TEVAR WAS PERFORMED ALTHOUGH IT WAS A PREEMPTIVE TREATMENT. NORMALLY, TEVAR SHOULD BE PERFORMED AFTER DEBRANCHING, BUT SINCE THERE WAS A LARGE ENTRY IN ZONE 4, THE RELAYPRO WAS IMPLANTED FROM NEAR THE TOP OF THE AORTIC ARCH, EVEN THOUGH IT WAS NOT A HEALTHY AREA OF THE VESSEL. THE PRESSURE GRADIENT IN THE LEFT COMMON FEMORAL ARTERY WAS RESOLVED BY CLOSING THE ENTRY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. WHEN THE PATIENT AWOKE, HIS/HER COMMUNICATION LEVEL AND GAIT FUNCTION HAD DETERIORATED FROM BEFORE THE PROCEDURE, AND A CEREBRAL INFARCTION WAS SUSPECTED. UPON EXAMINATION, A CEREBRAL INFARCTION WAS CONFIRMED. THE PATIENT IS SCHEDULED TO UNDERGO REHABILITATION TO RECOVER HIS/HER FUNCTIONS (CURRENTLY HOSPITALIZED). PHYSICIAN'S COMMENT: IT IS UNKNOWN IF THE DEBRIS WAS MIGRATED DURING THE ADVANCEMENT OF THE RELAYPLUS OR BY MANIPULATION OF THE CATHETER. I WAS VERY CAREFUL WITH ALL MY MANIPULATIONS, BUT IT TURNED OUT LIKE THIS. I THOUGHT THE INCIDENCE OF THE EMBOLISM WAS LOW FOR A DISSECTION CASE, BUT I HAVE TO BE CAREFUL. OPERATION TYPE: TEVAR. BLOOD LOSS: AMOUNT IS UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE: SCHEMA ATTACHED

  Patient problems: Insufficient Information; Stroke/CVA

  MAUDE report 20857837 ↗

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-2160-2026 · Apr 22, 2026 · Open, Classified
  RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-
• 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