RelayPro Thoracic Stent-Graft System 28-N4-36-109-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150485), received between Aug 28, 2024 and Jul 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 reports).

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.

• MalfunctionJul 28, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  "THIS WAS THE 3RD STENT PLACED DURING THE PROCEDURE. PREVIOUS 2 WERE DEPLOYED WITHOUT AN ISSUE. THE LAST ONE WOULD NOT DEPLOY/RELEASE PROPERLY. WHEN THE SURGEON WAS ON STEP 3, RELEASING THE PROXIMAL CLASP, IT WOULD NOT CLICK COMPLETELY ALL THE WAY BACK." PATIENT OUTCOME: "PATIENT IS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636853 ↗
• MalfunctionAug 28, 2024Activation, Positioning or Separation Problem; Difficult or Delayed Separation; Activation, Positioning or Separation Problem; Difficult or Delayed Separation

  "PHYSICIAN CHOSE 36-100 GRAFT TO LAND AT LSA. INTRODUCED GRAFT ONTO THE WIRE IN POSITION 1, ADVANCED PROXIMAL OUTER SHEATH/TIP TO DISTAL LANDING ZONE. THEN ADVANCED INNER SHEATH TO LSA WHICH IS THE PROX LANDING ZONE. PUT CONTROLLER KNOB IN POSITION 2. HAD RESIDENT TURN THE DEPLOYMENT GRIP COUNTERCLOCKWISE TO UNSHEATH THE FIRST COVERED STENT. THE RESIDENT CONTINUED TO TURN THE DEPLOYMENT GRIP BUT NOTHING MOVED. AT THE SAME TIME THE DEPLOYMENT GRIP BUTTON WAS DEPRESSED. WE TRIED DIFFERENT TROUBLESHOOTING TECHNIQUES AND CONTINUED TO TRY TO UNSHEATH THE INNER SHEATH BUT NOTHING MOVED. FINALLY DR. (B)(6) SCRUBBED IN, MOVED THE DISENGAGEMENT BUTTON A FEW TIMES, TRIED TO ROTATE THE DEPLOYMENT GRIP WITH NO LUCK, THEN PUSHED THE BUTTON DOWN AND PULLLED BACK WITH SOME FORCE TO DEPLOY THE GRAFT. WHEN THE RESIDENT WENT TO STEP3 TO RELEASE THE GRAFT FROM THE DEPLOYMENT SYSTEM IT WOULD LOCK IN PLACE SO WE HELD THEM TOGETHER WHILE RETRACTING THE TIP BACK INTO THE SHEATH. GRAFT IS IN BIOHAZARD BAG AT THE HOSPITAL WAITING FOR THE REP TO COME BACK FROM VACATION TO RETURN IT. REP NAME (B)(6)." PATIENT OUTCOME: "PT. OUTCOME SUCCESSFUL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091370 ↗

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