RelayPro Thoracic Stent-Graft System 28-N4-34-209-30URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843576151062), received between Sep 29, 2025 and Jan 2, 2026 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Patient-Device Incompatibility

  "SUBJECT PRESENTED AN INTRAMURAL HEMATOMA (IMH) AND WAS IMPLANTED BY A RELAYPRO NBS ON (B)(6) 2024. THE PATIENT WAS ADMITTED ON (B)(6) 2024 WITH POST-OPERATIVE STROKE (CVA). INVESTIGATOR DEEMED THIS EVENT RELATED TO PROCEDURE AND DEVICE. SUBJECT UNDERWENT THROMBECTOMY WITH STENT PLACEMENT AND WAS DISCHARGE ON (B)(6) 2024. PENDING SOURCE DOCUMENTATION AND IMAGING FOR STROKE AS WELL AS CONFIRMATION OF DEVICES USED." PATIENT OUTCOME: "PATIENT WAS DISCHARGE ON (B)(6) 2024 AND THE EVENT WAS RESOLVED WITHOUT SEQUALE."

  Patient problems: Stroke/CVA

  MAUDE report 23944208 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  "PARAPLEGIA: THE RELAY PRO STENT GRAFT WAS IMPLANTED TO TREAT A DESCENDING AORTIC ANEURYSM THAT WAS LOCATED AROUND THE T9-T10 SEGMENT OF THE THORACIC SPINAL CORD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ENDOLEAK. HOWEVER, AFTER THE PROCEDURE, THE PATIENT COULD NOT MOVE BOTH LEGS, AND PARAPLEGIA IN THE LOWER HALF OF THE BODY WAS IDENTIFIED. SINCE THE PATIENT COULD MOVE BOTH ARMS AND HAD A SENSE OF TOUCH IN THE LEGS, THE PATIENT WAS TRANSFERRED TO THE ICU FOR OBSERVATION. PHYSICIAN'S COMMENT: THE PROCEDURE WAS PERFORMED UNDER THE UNDERSTANDING OF BOTH THE PHYSICIAN AND THE PATIENT THAT IMPLANTING A STENT GRAFT WOULD COVER THE ADAMKIEWICZ ARTERY, WHICH IS LOCATED AT THE DISTAL END OF THE AORTIC ANEURYSM. THIS EVENT OCCURRED DUE TO THE IMPLANTATION OF A STENT GRAFT, BUT NOT BECAUSE THE STENT GRAFT WAS A RELAY PRO. PHYSICIAN'S COMMENT ON THE CAUSAL RELATIONSHIP: THERE WAS NO DIRECT CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THIS EVENT. (THIS EVENT WOULD HAVE OCCURRED EVEN IF IT WERE NOT A RELAY PRO.) OPERATION TYPE: TEVAR. NO BLOOD LOSS. ANCILLARY DEVICE USED: 28-N4-32-209-32U (LOT: 2410020354). NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. NO PRE-CASE PLAN AVAILABLE DUE TO HO

  Patient problems: Paraplegia

  MAUDE report 23645248 ↗
• DeathSep 29, 2025Separation Failure; Separation Failure

  "AS STATED ABOVE, PREVIOUS 30X32X 100 THORAFLEX IMPLANTED WEEK PRIOR (ON (B)(6)) WITH THE PLAN TO EXTEND WITH A TEVAR DOWN TO JUST PROXIMAL OF CELIAC. - CHRONIC DISSECTION. AFTER DISCUSSION OF CASE PLAN, WE CHOSE 34/30 X 200 TAPERED NBS. AS THE PROCEDURE COMMENCED, ALL WAS NORMAL THROUGHOUT EACH STEP OF DEPLOYMENT UNTIL STEP 3 WHEN, ALTHOUGH THE RELEASE MECHANISM DID TRAVERSE CAUDALLY (ON THE STERILE FIELD) WITH NO ISSUE AND AS PLANNED, & WE MOVED TO STEP 4 IN AN EFFORT TO REMOVE THE PUSHER ROD (PULL BACK) WE SAW THAT THE ROD WOULD NOT TRAVERSE OVER THE WIRE (WHILE ALSO WATCHING ON FLOURO) TO SEE THAT THE STENT GRAFT WAS TRAVERSING (MOVING) WITH THE ROD ITSELF ON GENTLE MOVEMENT. IT WAS THEN THAT WE DECIPHERED THAT THE CLASP WAS NOT RELEASED FROM THE STENT GRAFT. AFTER WORKING UNDER MY DIRECTION TO TROUBLESHOOT WITH FIRST STEP TO GENTLY MANEUVER THE PUSHER ROD UP/DOWN AND TWIST SIDE TO SIDE FOLLOWED BY CUTTING THE HYPO TUBE & MOVING THE (GREEN) TUBE IN A CAUDAL DIRECTION, THERE WAS NO CHANGE. I THEN REACHED OUT TO R&D TEAM (B)(6) TO PROVIDE DIRECTION IN WHICH THEY CONNECTED WITH ME VIA TEAMS CALL WHEREBY I WAS ABLE TO PROVIDE LIVE FEED OF OR AND WORK TO TROUBLESHOOT. AFTER 4 HRS OR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 23169187 ↗

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