RelayPro Thoracic Stent-Graft System 28-N4-26-104-26URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150430), received between Nov 6, 2024 and Nov 6, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Ejection Problem; Difficult or Delayed Separation; Ejection Problem; Difficult or Delayed Separation

  "DEFECTIVE: THE RELAYPRO CONCERNED AND A RELAYPRO (28-N4-34-154-30U, LOT#2405280110) WERE IMPLANTED STACKED IN A THORACIC AORTIC DISSECTION CASE. DURING IMPLANTATION OF THE RELAYPRO CONCERNED, THE STENT GRAFT WAS DEPLOYED WITH THE CONTROLLER IN POSITION 2 WITHOUT ANY PROBLEMS. HOWEVER, WHEN THE APEX HOLDER KNOB (MARKED 3) WAS PULLED BACK PROXIMALLY, THE CLASP WAS NOT RELEASED. ALTHOUGH THE APEX HOLDER KNOB COULD BE PULLED, THE APEX HOLDER KNOB AND THE APEX HOLDER WERE NOT INTERLOCKED, AND THE APEX HOLDER COULD NOT BE PULLED. BY USING PEAN FORCEPS TO GRASP AND PULL THE OUTER CONTROL TUBE (GREEN TUBE) IN THE SLOT AT THE PROXIMAL END OF THE STAINLESS-STEEL ROD, AND THE APEX HOLDER COULD BE PULLED, AND THE STENT GRAFT WAS SUCCESSFULLY RELEASED. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR. ANCILLARY DEVICE: 28-N4-34-154-30U (LOT#2405280110). BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY (TC# (B)(4))." PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624872 ↗

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-2160-2026 · Apr 22, 2026 · Open, Classified
  RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-
• 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