RelayPro Thoracic Stent-Graft System 28-N4-42-159-42URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150645), received between Jan 2, 2025 and Jan 2, 2025 — classified as 1 death.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJan 2, 2025Retraction Problem; Material Deformation; Insufficient Device Problem Information; Retraction Problem; Material Deformation; Insufficient Device Problem Information

  "PATIENT HAD PREVIOUS TEVAR WITH CHRONIC TYPE B DISSECTION AND 7.2 CM ANEURYSM; HE RUPTURED AND WAS STABLE AT TIME OF IMPLANTATION. HIS PREVIOUS TEVAR EXTENDED TO 5 CM PROXIMAL TO CELIAC ARTERY; THE RUPTURE WAS AT THE DISTAL END OF THE EXISTING GRAFT. WE OPENED N4-42-159-42U REF#(B)(4) AND "BAREBACKED IT" INTO THE R CIA. DEVICE WENT UP WITH NO ISSUE; IN THE VISCERAL SEGMENT WE TOOK THE FLEXIBLE INNER SHEATH OUT OF HARD OUTER SHEATH "IN STEP 1" AND PLACED IT IN LANDING ZONE; WE MOVED TO STEP 2 AND DR (B)(6) ATTEMPTED TO TURN HANDLE COUNTER CLOCKWISE TO LINE UP D MARKER WITH GRAFT MARKER. DR (B)(6) HAS DEPLOYED OVER 50 RELAY PROS AND IS A TRAINER FOR TA. HE COMPLAINED THAT THE HANDLE KEPT RECOILING BACK TO ORIGINAL POSITION EVERY TIME HE TURNED IT; UNDER FLUORO, IT WAS CLEAR THAT THE D MARKER WASN'T MOVING, AND EVERY TIME HE TURNED THE HANDLE, THE NOSE CONE WOULD RECOIL DOWN TOWARD THE PATIENTS FEET. AFTER A FEW ATTEMPTS IT WAS CLEAR THE GRAFT WAS GETTING SCRUNCHED WITH EVERY ATTEMPTED TURN OF THE HANDLE. WE MOVED THE CONTROL PANEL TO STEP 1 IN AN ATTEMPT TO RECAPTURE THE GRAFT (STILL CONSTRAINED BY INNER SHEATH) AND WERE UNABLE TO (EVEN THOUGH WE HAVE DONE THIS BEFORE IN THE PAST).

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054799 ↗

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