RelayPro Thoracic Stent-Graft System 28-N4-36-199-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150744), received between Nov 20, 2024 and Mar 10, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMar 10, 2025Mechanical Problem; Failure to Advance; Difficult to Advance; Mechanical Problem; Failure to Advance; Difficult to Advance

  "THE DEVICE WAS OPENED AND FLUSHED CORRECTLY. I HAD THE PHYSICIAN ADVANCE THE DEVICE TO OUR DISTAL LANDING ZONE. HE BEGAN TO ADVANCE THE INNER CANNULA IN POSITION 1. WHEN HE BEGAN TURNING THE MECHANICAL ADVANTAGE IN THE CORRECT DIRECTION, IT SOUNDED LIKE THE INTERNALS OF THE "DEVICE" WERE GRINDING AND BREAKING. THE PHYSICIAN EXPRESSED THAT HE COULD FEEL "GRINDING" IN THE MECHANICAL ADVANTAGE. I HAD HIM IMMEDIATELY REMOVE THE DEVICE FOR A NEW DEVICE. " PATIENT OUTCOME:"PATIENT WAS NOT INJURED/HARMED. NO FURTHER SURGICAL PROCEDURES WERE REQUIRED DUE TO THE DEVICE. WE PROCEEDED WITH THE PROCEDURE WITH ANOTHER RELAY PRO GRAFT THAT PERFORMED PERFECTLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566751 ↗
• InjuryNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  "BROKEN: THE RELAY PRO STENT-GRAFT WAS USED IN EMERGENCY TEVAR. THE STENT-GRAFT WAS IMPLANTED IN A SEVERELY TORTUOUS AORTA VIA PULL-THOUGH TECHNIQUE. AFTER IMPLANTATION, WHEN THE ENTIRE DELIVERY SYSTEM WAS BEING WITHDRAWN WITH THE DIAL SET TO "4", THE INNER CANNULA GOT CAUGHT ON THE LESSER CURVATURE SIDE OF THE STENT-GRAFT AND WAS DIFFICULT TO BE REMOVED. SEVERAL ATTEMPTS WERE MADE TO REMOVE IT BY PUSHING, PULLING, AND ROTATING THE SILVER ROD, BUT THE PHYSICIAN FELT SOMETHING WRONG. IT WAS FOUND THAT WHEN THE SILVER ROD WAS PULLED, THE ROD WAS ABLE TO BE PULLED, BUT THE DELIVERY SYSTEM TIP DID NOT SEEM TO MOVE UNDER FLUOROSCOPY. WHEN THE ENTIRE DELIVERY SYSTEM WAS PULLED SLOWLY, THE ENTIRE DELIVERY SYSTEM WAS ABLE TO BE PULLED IN THE SAME WAY, BUT THE DELIVERY SYSTEM TIP DID NOT APPEAR TO MOVE UNDER FLUOROSCOPY. IT WAS DETERMINED THAT THE DELIVERY SYSTEM TIP (INNER CANNULA) HAD TORN OFF. THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED OVER THE GUIDEWIRE, BUT THE DELIVERY SYSTEM TIP AND INNER CANNULA WERE LEFT IN THE BODY. FORTUNATELY, SINCE THE PROCEDURE WAS BEING PERFORMED VIA PULL-THROUGH TECHNIQUE, A GUIDING SHEATH (6 FR) WAS ADVANCED FROM THE BRACHIOCEPHALIC ARTERY SIDE AND WAS PUSH

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735113 ↗

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