RelayPro Thoracic Stent-Graft System 28-N4-34-209-34URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843576150737), received between Oct 16, 2024 and Nov 10, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Retraction Problem; Activation, Positioning or Separation Problem; Difficult or Delayed Separation; Retraction Problem; Activation, Positioning or Separation Problem; Difficult or Delayed Separation

  "TEVAR OF DESCENDING THORACIC AORTA PROXIMAL ZONE 4 TO DISTAL ZONE 5/PROXIMAL ZONE 6. PATIENT HAS PREVIOUSLY PLACED GORE TEVAR IN DISTAL ZONE 4 TO MID-DISTAL ZONE 5. ACCESS GAINED WITH 8 FR AND PIGTAIL CATHETER TRACKED OVER GLIDEWIRE INTO AORTIC ARCH. ANGIOGRAM AND MARKING LANDMARKS ON SCREEN, LUNDERQUIST WIRE ADVANCED THROUGH CATHETER AND CATHETER REMOVED. RELAY PRO DEVICE PER IFU. 8 FR SHEATH REMOVED AND RELAY PRO DEVICE ATTACHED INTO POSITION. DELIVERY SYSTEM SWITCHED TO POSITION 2 AND INNER CURVED SHEATH ADVANCED WITHOUT ISSUE. ATTEMPTED TO RETRACT FABRIC SHEATH TO START UNCOVERING STENT GRAFT BY TURNING HANDLE COUNTERCLOCKWISE BUT NOTICED D MARKER NOT MOVING. SWITCHED BACK TO POSITION 1 AND ADVANCE THE SYSTEM SLIGHTLY, SWITCHED BACK TO POSITION 2 AND DEPRESSED BUTTON AND UNSHEATHED STENT WITHOUT ISSUE. TURNED POSITION 3 AND TRIED TO DISCONNECT STENT BUT WAS MEETING RESISTANCE. A LITTLE MORE EFFORT AND STENT WAS DETACHED. SWITCHED TO POSITION 4 AND NOSE CONE WAS RETRACTED INTO OUTER SHEATH. DEVICE REMOVED, 18 FR DRYSEAL INSERTED SO THAT FINAL RUN COULD BE DONE WHICH SHOWED GOOD SEAL PROXIMAL AND DISTAL AND EXCLUSIVE OF ANEURYSM. CLOSURE WITH TWO PERCLOSE DEVICES." PATIENT OUTCO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512849 ↗
• MalfunctionNov 6, 2024Ejection Problem; Difficult or Delayed Separation; Ejection Problem; Difficult or Delayed Separation

  "DEFECTIVE: THE RELAY PRO STENT-GRAFT CONCERNED AND A RELAY PRO STENT-GRAFT (28-N4-30-104-30U, LOT#: 2401090104) WERE USED TO TREAT AORTIC DISSECTION. AFTER THE FIRST STENT-GRAFT (28-N4-30-104-30U, LOT#: 2401090104) WAS IMPLANTED WITHOUT ANY PROBLEM, THE SECOND STENT-GRAFT CONCERNED WAS DEPLOYED WITH THE CONTROLLER IN THE "2" POSITION WITHOUT ANY PROBLEM. HOWEVER, THE APEX HOLDER COULD NOT BE RELEASED FROM THE DELIVERY SYSTEM TIP EVEN THOUGH THE APEX HOLDER KNOB WAS PULLED IN THE "3" POSITION. ALTHOUGH THE APEX HOLDER KNOB WAS ABLE TO BE PULLED IN THE "3" POSITION AND TORQUE WAS TRANSMITTED TO THE APEX HOLDER, THE APEX HOLDER WAS PULLED ALONG WITH THE DELIVERY SYSTEM TIP DISTALLY AND WAS NOT RELEASE. (AT THAT TIME, AS BAIL-OUT TECHNIQUE, THE STAINLESS-STEEL ROD WAS PUSHED AND ROTATED IN THE "4" POSITION, AND THE APEX HOLDER KNOB WAS PULLED IN THE "3" POSITION WHILE THE STAINLESS-STEEL ROD WAS BEING PUSHED IN THE "4" POSITION. HOWEVER, THE APEX HOLDER DID NOT SEEM TO BE RELEASED.) CUT-DOWN TECHNIQUE WAS THEREFORE USED ON THE CONTRALATERAL SIDE (LEFT LEG) TO INSERT A DRY SEAL SHEATH (18FR, GORE). A BALLOON CATHETER WAS THEN ADVANCED THROUGH THE DRY SEAL SHEATH, AND THE BALLOON WAS IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623642 ↗
• InjuryOct 16, 2024Device Endoleak; Device Endoleak

  "ENDOLEAK (TYPE IIIA): STENT-GRAFT IMPLEMENTATION WAS PERFORMED TO TREAT A DESCENDING AORTIC ANEURYSM. A STENT-GRAFT (28-N4-34-209-34U) WAS FIRST IMPLEMENTED ON THE DISTAL SIDE AND THE STENT-GRAFT (28-M4-40-195-36U) WAS THEN IMPLEMENTED ON THE PROXIMAL SIDE. POST DILATATION WAS PERFORMED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ONE WEEK AFTER THE PROCEDURE, HOWEVER, CONTRAST-ENHANCED CT REVEALED A TYPE IIIA ENDOLEAK. SINCE THE PATIENT IS OLD, THE PATIENT IS BEING FOLLOWED UP. IF THE ANEURYSM TENDS TO ENLARGE, ADDITIONAL TREATMENT WILL BE SCHEDULED. OPERATION TYPE: STENT GRAFT IMPLANTATION. BLOOD LOSS: UNKNOWN. ANCILLARY DEVICE USED: 28-N4-34-209-34U. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE (SEE THE ATTACHED SCHEMA.) ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED. (TC#(B)(6))". PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: Clinical Endoleak

  MAUDE report 20465573 ↗

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