RelayPro Thoracic Stent-Graft System 28-N4-40-204-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843576151093), received between Dec 19, 2024 and Aug 18, 2025 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathAug 18, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  "ON POST-OPERATIVE DAY 189 (B)(6) 2024) OF THE THORAFLEX HYBRID PLEXUS, SUBJECT (B)(6) EXPERIENCED AN AE OF RIGHT COMMON FEMORAL ARTERY PSEUDOANEURYSM, WITH FURTHER DETAILS STATING "A SMALL RIGHT COMMON FEMORAL ARTERY PSEUDOANEURYSM (14MM) WITH FOCAL DISSECTION". THERE IS CURRENTLY NO INFORMATION AVAILABLE ON THE TREATMENT OR OUTCOME OF THE EVENT. AS EXPLAINED ABOVE, THERE IS NO CAUSALITY ASSESSMENT FOR THE EVENT, AND SITE HAS BEEN REQUESTED TO COMPLETE AS SOON AS POSSIBLE. MEDICAL MONITOR HAS ASSESSED THE EVENT AS POSSIBLY RELATED TO BOTH THORAFLEX HYBRID AND RELAYPRO NBS DEVICES, HENCE REPORTABLE. PATIENT DEATH: (B)(6) 2025 - CAUSE OF DEATH IS UNKNOWN, UNDETERMINED IS CAUSE OF DEATH IS RELATED TO THE DEVICE." PATIENT OUTCOME: "THERE IS CURRENTLY NO DETAILS AVAILABLE ON THE OUTCOME OF THE EVENT. 59 DAYS POST-OP THE PATIENT CHART WAS UPDATED TO DECEASED, ADDITIONAL INFORMATION PENDING PATIENT DEATH: (B)(6) 2025 - CAUSE OF DEATH IS UNKNOWN, UNDETERMINED IS CAUSE OF DEATH IS RELATED TO THE DEVICE."

  Patient problems: Pseudoaneurysm; Vascular Dissection

  MAUDE report 22833908 ↗
• InjuryAug 6, 2025Material Deformation; No Apparent Adverse Event; Material Deformation; No Apparent Adverse Event

  "WHEN DEPLOYING THE FIRST STENT GRAFT, AS WE WERE DELIVERING, THERE SEEMED NO ISSUES DEPLOYING THE STENT GRAFT. WE CONTINUE TO DEPLOY THE REST OF THE GRAFT JUST FINE UNTIL IT WAS NOTICED THERE WAS SOME INFOLDING IN THE PROXIMAL SEAL ZONE OF THE INNER CURVE OF THE GRAFT. THERE WAS AN AREA OF THE NATIVE ANATOMY IN THE AORTA THAT WE DISCUSSED COULD HAVE CAUSED THE PROBLEM BECAUSE IT SEEMED TO BE ULCERATED NEAR THE ZEAL ZONE. THIS PROBLEM WAS THEN RESOLVED BY PLACING ANOTHER THORACIC GRAFT MORE PROXIMAL AND FLATTENING THE INFOLDING THAT HAD HAPPENED. NO LIVE PICTURES OF THE CASE WERE TAKEN." PATIENT OUTCOME: "THERE WAS NO PATIENT HARM. OUTCOME WAS GREAT AND ISSUE WAS RESOLVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22725944 ↗
• InjuryJan 15, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "DURING THE EARLY FOLLOW-UP A TYPE 1B ENDOLEAK WAS FOUND ON THE IMAGING. CONTRAST MATERIAL IN EXCLUDED SAC AT THE DISTAL ASPECT OF THE STENT, WHICH THE PI DEEMED RELATED TO MAIN BODY OF DEVICE. SUBJECT ALSO HAD LOWER EXTREMITY PARESTHESIA. WEAKNESS, TINGLING, AND NUMBNESS IN BOTH LEGS FROM LOW BLOOD PRESSURE." PATIENT OUTCOME: "PI MONITORING EVENT; AND DETERMINE IF INTERVENTION IS NEEDED."

  Patient problems: Clinical Endoleak; Neuropathy

  MAUDE report 21162188 ↗
• InjuryDec 19, 2024Difficult to Advance; Insufficient Device Problem Information; Difficult to Advance; Insufficient Device Problem Information

  "PATIENTS WAS SCHEDULED FOR TEVAR PROCEDURE ON (B)(6)2024. PROCEDURE WAS GOING WELL UNTIL "S" THORACIC AORTIC WOULD NOT STRAIGHTEN OUT WITH 2 BILATERAL LUNDQUIST WIRES. THE FIRST DEVICE WAS ABLE TO ADVANCE THE TRANSFERS AORTA BUT NO FURTHER DUE TO THE ANGULATION OF THE THORACIC AORTA. THE DEVICE WAS DEPLOYED 4CM DISTAL TO LSA WITHOUT INCIDENT. THE 2ND DEVICE NEEDED TO BE ADVANCED PROXIMALLY TO EXISTING STENT GRAFT JUST DISTAL TO LSA. THE DECISION WAS TO USE BODY-FLOSS FROM THE RIGHT BRACHIAL TO RIGHT FEMORAL TO CREATE ENOUGH TENSION ON THE WIRE TO RAIL THE DEVICE. THIS WAS DONE SUCCESSFULLY BUT THE DISTAL ANGIOGRAM SHOWED AN AORTIC DISSECTION. THIS DECISION WAS TO LEAVE IT ALONE AS THE DISSECTION DID NOT EXTEND ABOVE EXISTING STENT GRAFT OUR BELOW EXISTING ABDOMINAL STENT GRAFT. ON (B)(6) 2024 AT 1330 THE PHYSICIAN CALLED ME TO INFORM ME THAT THE PATIENT'S HEMOGLOBIN HAD DECREASED, AND CT WAS ORDERED AND SHOWS A THORACIC RUPTURE AT THE LEVEL OF THE VISCERAL VESSELS. PHYSICIAN HAS DECIDED TO NOT TREAT AS THE PATIENT IS 85 YEARS OLD AND HAS OTHER CO-MOBILITIES. (PHYSICIAN SENT ME VIDEO OF CT THAT SHOWS RUPTURE)." PATIENT OUTCOME: "PATIENT CURRENTLY IS STABLE, BUT HOSPICE HAS BEEN CON

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Rupture; Vascular Dissection

  MAUDE report 20982026 ↗

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