RelayPro Thoracic Stent-Graft System 28-N4-46-209-46URecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843576150799), received between Aug 27, 2024 and Jan 16, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Use of Device Problem

  "PATIENT PREPPED PER NORMAL PROTOCOLS. BOTH LSA AND CELIAC MARKED WITH IVUS. A 46X42X200 RELAY PRO NBS PLACED JUST PROXIMAL TO CELIAC. SURGEON THAN LANDED A 46X46X200 RELAY PRO NBS DISTAL TO LSA. VASCULAR FELLOW WAS DEPLOYING RELAY PRO UNDER INSTRUCTION FROM ATTENDING PHYSICIAN. FELLOW DID NOT TURN CONTROL PANEL TO #2 WHILE TRYING TO DEPLOY GRAFT. GRAFT MAY HAVE BEEN PULLED SLIGHTLY BACK WHEN PROBLEM IDENTIFIED AND FIXED AND GRAFT ULTIMATELY IDENTIFIED. SURGEON SEEMED FINE WITH GRAFT PLACEMENT ON FINAL ANGIO AND CLOSED PATIENT." PATIENT OUTCOME: "PHYSICIAN NOTIFIED REP OF INFOLDING ISSUE ON INNER CURVE OF THE 46X46X200 GRAFT. PLAN TO TREAT PATIENT ON 12-19 BY BALLOONING OR USE OF PALMAZ STENT. CASE PLAN AVAILABLE, BILLING SHEET AND BEFORE/AFTER CT SCANS AVAILABLE."

  Patient problems: Insufficient Information

  MAUDE report 24097402 ↗
• MalfunctionDec 26, 2025Material Invagination; Material Deformation; No Apparent Adverse Event; Material Invagination; Material Deformation; No Apparent Adverse Event

  "INFOLDING OF THE STENT-GRAFT: A CT SCAN PERFORMED ONE WEEK AFTER THE PROCEDURE REVEALED THAT INFOLDING HAD OCCURRED ON THE PROXIMAL SIDE OF THE STENT-GRAFT. THE PHYSICIAN THEN REVIEWED THE FINAL ANGIOGRAPHY PERFORMED IMMEDIATELY AFTER THE PROCEDURE AND FOUND THAT THE INFOLDING HAD ALREADY OCCURRED BY THAT POINT. NO ADDITIONAL TREATMENT HAS BEEN PERFORMED OR IS PLANNED. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. IMAGE AVAILABLE UPON REQUEST. PRE-CASE PLAN AVAILABLE UPON REQUEST. ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST. ((B)(4))" PATIENT OUTCOME: "NO DAMAGE TO THE PATIENT'S HEALTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898536 ↗
• MalfunctionDec 18, 2025Material Deformation; No Apparent Adverse Event; Material Deformation; No Apparent Adverse Event

  "INFOLDING OF THE STENT GRAFT: ON (B)(6) 2023, THE PATIENT UNDERWENT TAR (TRIPLEX 30 MM), ET (TRIPLEX 30 M) AND CABG. ON (B)(6) 2025, TEVAR WAS PERFORMED USING THE RELAYPRO DEVICES. IN THIS CASE, A RELAYPRO (28-N4-40-204-40U) WAS IMPLANTED CENTRALLY, NOT COVERING THE PERIPHERAL ANASTOMOSIS OF THE ET, AND THE RELAYPRO CONCERNED (28-N4-46-209-46U) WAS THEN IMPLANTED PERIPHERALLY, JUST ABOVE THE CELIAC ARTERY. THREE STENT RINGS OF THE RELAY PRO CONCERNED WERE EXPOSED FROM THE ET, AND THE RELAYPRO CONCERNED WAS IMPLANTED WITHOUT COVERING THE ENTRY OF THE ET. THE TWO RELAYPRO DEVICES WERE IMPLANTED WITH THREE STENTS OVERLAPPING. ON (B)(6) THE INFOLDING OF THE FIRST STENT OF THE RELAYPRO CONCERNED WAS CONFIRMED, AND BALLOONING WAS PERFORMED. HOWEVER, THE INFOLDING WAS NOT RESOLVED. TEVAR IS SCHEDULED FOR A LATER DATE. OPERATION TYPE: TEVAR ANCILLARY DEVICE: 28-N4-40-204-40U BLOOD LOSS: NONE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839478 ↗
• InjurySep 25, 2025Material Invagination; Material Deformation; No Apparent Adverse Event; Device Endoleak; Material Invagination; Material Deformation; No Apparent Adverse Event; Device Endoleak

  "ENDOLEAK / INFOLDING OF THE STENT GRAFT: STENT-GRAFT IMPLANTATION WAS PERFORMED TO TREAT AN AORTIC ANEURYSM. THE RELAY PRO STENT-GRAFT CONCERNED WAS STACKED WITH ANOTHER RELAY PRO STENT-GRAFT (28-N4-42-159-42U). THE PROCEDURE WAS COMPLETED WITHOUT ANY ENDOLEAK. HOWEVER, A POSTOPERATIVE CT SCAN REVEALED AN ENDOLEAK AND INFOLDING OF THE PERIPHERAL END OF THE RELAY PRO STENT-GRAFT CONCERNED THAT WAS IMPLANTED AS A CENTRAL DEVICE. NO ADDITIONAL TREATMENT HAS BEEN PERFORMED, BUT IMPLANTING ANOTHER STENT-GRAFT TO REINFORCE THE IMPLANTED STENT-GRAFTS IS BEING CONSIDERED. SINCE THERE IS A POSSIBILITY THAT THE REMAINING ENDOLEAK IN THE LESSER CURVATURE IS AN ENDOLEAK TYPE 3A, RESULTING FROM THE INFOLDING, ADDITIONAL TREATMENT IS BEING CONSIDERED WHILE MONITORING TRANSITION OF THE ANEURYSM DIAMETER. OPERATION TYPE: STENT-GRAFT IMPLANTATION ANCILLARY DEVICE USED: 28-N4-42-159-42U NO BLOOD LOSS NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY PRE-CASE PLAN AVAILABLE: SEE THE ATTACHED SCHEMA ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST (TC#BM250802376)" PATIENT OUTCOME: "THE PATIENT HAS NOT EXPERIENCED ANY HEALTH ISSUES THUS FAR, BUT ADDITIONAL TREATMENT IS BEING CONSIDERED."

  Patient problems: Clinical Endoleak; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23142466 ↗
• MalfunctionJan 17, 2025Material Invagination; Difficult or Delayed Separation; Material Invagination; Difficult or Delayed Separation

  "UNABLE TO RELEASE THE SUPPORT WIRES: THE TREATMENT OF THE DESCENDING AORTIC ANEURYSM WAS PERFORMED WITH A PLAN TO PLACE A STENT-GRAFT (RELAYPRO 28-N4-40-154-40U, LOT# 2301110006) DISTALLY AND THEN THE STENT-GRAFT CONCERNED (RELAYPRO28-N4-46-209-46U, LOT#2410180344) PROXIMALLY. AFTER THE DISTAL STENT-GRAFT WAS SUCCESSFULLY IMPLANTED, THE PROXIMAL STENT-GRAFT WAS DELIVERED BY ADVANCING THE INNER SHEATH WITH THE CONTROLLER IN THE "1" POSITION, AND THEN SUCCESSFULLY DEPLOYED WITH THE CONTROLLER IN THE "2" POSITION. TO RELEASE THE PROXIMAL CRISP, THE APEX RELEASE GRIP WAS ROTATED AND PULLED BACK. THE CLASP ON THE GREATER CURVATURE SIDE WAS ABLE TO BE RELEASED, HOWEVER, THE SUPPORT WIRES ON THE LESSER CURVATURE SIDE WERE UNABLE TO BE RELEASED FROM THE STENT-GRAFT. ALTHOUGH RELEASE OF THE SUPPORT WIRES WAS ATTEMPTED BY ADVANCING AND RETRACTING THE DELIVERY SYSTEM OR RETRACTING THE STAINLESS-STEEL ROD WITH THE CONTROLLER IN THE "4" POSITION, THE SUPPORT WIRES WERE STILL UNABLE TO BE RELEASED FROM THE STENT-GRAFT, BUT RATHER SHOWED MOVEMENT PULLING THE LESSER CURVATURE STENT-GRAFT INWARD. THE OUTER SHEATH WAS ADVANCED TOWARD THE SUPPORT WIRES WHILE VARYING THE DIRECTION OF THE FORCE APPLIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180215 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  "AN EXTENSION PROCEDURE WAS PLANNED BUT NOT AT THE SAME TIME AS THE THORAFLEX HYBRID. THORAFLEX HYBRID WAS IMPLANTED ON (B)(6) 2024. NO DISTAL SEAL WAS INTENDED DUE TO A PLANNED EVAR EXTENSION AND DISTAL SEAL WAS OBTAINED. NO ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE. DELIVERY OF THE THORAFLEX HYBRID WAS SUCCESSFUL, DEPLOYED IN PLANNED LOCATION AND WITHDRAWAL OF DELIVERY SYSTEM WAS SUCCESSFUL. NO DEVICE DEFICIENCIES OCCURRED DURING THE INDEX TH PROCEDURE. PATIENT RECEIVED A EXTENSION ON (B)(6) 2024. A RELAY PRO NBS WAS IMPLANTED. THE PROCEDURE WAS ENDOVASCULAR - TEVAR AND RIGHT GROIN CUTDOWN. A TYPE IB ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE - THIS WAS INTENTIONAL. NO DEVICE DEFICIENCIES OCCURRED DURING THE PROCEDURE. DELIVERY OF THE STENT GRAFT WAS SUCCESSFUL, DEPLOYED IN PLANNED LOCATION AND WITHDRAWAL OF DELIVERY SYSTEM WAS SUCCESSFUL. EVENT DETAILS: ANEURYSM EXPANSION A FOLLOW UP CT CHEST/ABDOMEN/PELVIS SHOWING ANEURISM EXPANSION TO 8.9CM (AFTER NBS EXTENSION PROCEDURE)." PATIENT OUTCOME: "SURGICAL PROCEDURE CARRIED OUT - TEVAR, 4 VESSEL PMEG, EVAR. AE IS ONGOING, UNRESOLVED STILL TREATING AND THE SUBJECT REMAINS IN THE STUDY."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20075638 ↗

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