RelayPro Thoracic Stent-Graft System 28-N4-36-154-32URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150973), received between Nov 5, 2024 and Sep 15, 2025 — classified as 2 malfunctions.

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

• MalfunctionSep 15, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  "THE PATIENT NEEDED 2 TEVAR GRAFTS TO EXTEND DOWN THE THORACIC AORTA TO THE SMA ARTERY. THE CELIAC WAS CHRONICALLY OCCLUDED. THE PHYSICIAN USED THE RELAYPRO NBS FOR BOTH DEVICES WITHOUT A SHEATH. THE FIRST DEVICE WENT IN AND DEPLOYED WITHOUT ANY ISSUES. THE PHYSICIAN THEN INTRODUCED THE COMPLAINT DEVICE INTO THE PATIENT. THE DEVICE WAS ADVANCED SMOOTHLY THROUGH THE VASCULATURE AND THE GRAFT WAS THEN PUSHED OUT IN POSITION 1. NO ISSUES WERE NOTICED DURING THOSE STEPS. THE INNER SLEEVE WAS RETRACTED BACK IN POSITION 2 WITHOUT ANY ISSUES. DURING THE RETRACTION OF THE CLASPING MECHANISM OF STEP THREE I NOTICED THE SUPPORT WIRES MOVING BUT THE PROXIMAL CLASP ONLY MOVED 2-4MM. THE PHYSICIAN TRIED PUSHING THE CATHETER UP AND DOWN AS WELL AS ROTATING, BUT IT WOULD NOT RELEASE. WE GOT DOWN TO THE GREEN HYPOTUBE IN THE BACK AND TRIED CUTTING THAT LONGITUDINALLY TO SEE IF IT WOULD HELP AND IT DID NOT. EVENTUALLY WE WERE ABLE TO GET A SNARE AROUND THE CLASP WHILE MOVING THE NOSECONE UP AND THE 2 PIECES RELEASED. THE DEVICE WAS THEN REMOVED FROM THE BODY WITHOUT FURTHER ISSUES." PATIENT OUTCOME: "NO PATIENT CONSEQUENCE HAS BEEN REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057525 ↗
• MalfunctionNov 5, 2024

  DEPLOYING DEVICE IN THORACIC AORTA, THE INNER SHEATH JUMPED BACKWARDS CAUSING THE GRAFT TO "WIND-SOCK" AND DEPLOY LOWER THAN INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609120 ↗

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