RelayPro Thoracic Stent-Graft System 28-N4-40-259-40URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150898), received between Mar 14, 2025 and Mar 14, 2025 — classified as 1 malfunction.

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

• MalfunctionMar 14, 2025Difficult to Remove; Retraction Problem; Ejection Problem; Difficult or Delayed Separation; Difficult to Remove; Retraction Problem; Ejection Problem; Difficult or Delayed Separation

  "DURING THE CASE WHEN AT STEP 3 THE RELEASE CLASP DEPLOYMENT REQUIRED A HIGHER THAN USUAL AMOUNT OF FORCE TO DISCONNECT THE PROXIMAL INNER CORE NOSECONE FROM THE STENT. PHYSICIAN FOLLOWED STEP 3 AS RECOMMENDED IN IFU. UPON SLIDING THE BLACK GRIP OVER THE GRAY GRIP WITH NORMAL FORCE, THE STENT DID NOT VISUALLY DISENGAGE FROM THE NOSECONE UNDER LIVE FLOUROSCOPY. A HIGH LEVEL OF FORCE WAS APPLIED TO SLIDE THE BLACK GRIP BACK TO DISENGAGE THE STENT. IN ADDITION, UPON WITHDRAWING THE ENTIRE DEVICE, AFTER STEP 4 AND A RETURN TO STEP 2 THE DEVICE DID NOT REMOVE AS EASY AS IT DID ON ADVNCEMENT THROUGH THE ACCESS VESSELS. PHYSICIAN ROTATED, ADVANCED THEN RETRACTED MULTIPLE TIMES BEFORE DEVICE RELAEASE FROM ACCESS VESSELS. TWO PICTURES OF PROXIMAL DEVICE ARE AVAILABLE. DEVICE WAS DISCARDED." PATIENT OUTCOME: "NO COMPLICATIONS. ANTICIPATED OUTCOME ACHIEVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610050 ↗

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