RelayPro Thoracic Stent-Graft System 28-N4-38-154-38URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150621), received between Feb 6, 2025 and Nov 25, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Retraction Problem” (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.

• InjuryNov 25, 2025Retraction Problem; Activation, Positioning or Separation Problem; Retraction Problem; Activation, Positioning or Separation Problem

  "THE DEVICE WAS INSERTED BAREBACK INTO THE PATIENT THROUGH PERCUTANEOUS FEMORAL ARTERY ACCESS. IT WAS ADVANCED TO THE DIAPHRAGM WHILE IN STEP 1, THEN THE INNER SHEATH WAS PUSHED PROXIMALLY TO THE DESIRED PROXIMAL LANDING ZONE (LSA). AT THIS POINT, THE PHYSICIAN PERFORMED AN AORTOGRAM TO IDENTIFY THE LSA AND THEN PROCEEDED TO PUT THE DEVICE IN STEP 2. HE THEN BEGAN TURNING THE BLACK HANDLE COUNTERCLOCKWISE. THE D MARKER/INNER SHEATH DID NOT RETRACT, AND THE CATHETER BEGAN TO BOW UNDER FLUOROSCOPY. DR BRINK MENTIONED THE FELT STRONG RESISTANCE. HE CONTINUED TURNING THE BLACK KNOB IN THE SAME DIRECTION, BUT THE INNER SHEATH STILL DID NOT MOVE. HE THEN ATTEMPTED TO RECAPTURE THE FABRIC INNER SHEATH INTO THE HARD OUTERSHEATH IN STEP 1 BUT COULD NOT GET THE GRAFT-CONSTRAINED FABRIC INNER SHEATH BACK INTO THE HARD OUTER SHEATH IN-SITU. HE PULLED THE ENTIRE DEVICE OUT OF THE BOY, BRINGING INTIMA FROM THE EXTERNAL ILIAC ARTERY WITH IT. PATIENT THEN REQUIRED A CUTDOWN AND ILIAC-ENDARTERECTOMY. " PATIENT OUTCOME: "TRANSIENT INJURY/INTIMAL INJURY."

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 23645267 ↗
• InjuryFeb 6, 2025Premature Activation; Retraction Problem; Failure to Advance; Difficult to Advance; Premature Activation; Retraction Problem; Failure to Advance; Difficult to Advance

  "THE PATIENT HAD MULTIPLE PRIOR COMPLICATED PROCEDURES. INCLUDING 4 VESSEL SNORKELING AND RELINING OF ENTIRE AORTA FROM DESCENDING TO ILIACS USING RELAY AND TREO DEVICES. PREVIOUSLY THERE WAS A SUCCESSFUL SECONDARY PROCEDURE COMPLETED USING A RELAY TO FIX A TYPE 3 DEVICE SEPARATION. THE PT PRESENTED WITH ANOTHER SYMPTOMATIC TYPE 3 LEAK AND AN EMERGENT 3RD INTERVENTION WAS PLANNED TO BRIDGE THE SEPARATION. THE ACCESS WAS TIGHT AND THERE WAS ALOT OF MATERIAL ALREADY IMPLANTED. THE DOCTOR PERFORMED IVUS TO VERIFY HE WAS IN THE LUMAN OF THE DEVICES AND NOT IN/OUT STRUTS. WHEN DELIVERING THE RELAY UP THE RIGHT SIDE, HE MADE IT INTO THE ILIACS USING THE MAIN DELIVERY SYSTEM BUT DUE TO PRIOR STENTS WAS NOT ABLE TO ADVANCE FURTHER. THE DECISION WAS MADE TO START ADVANCING THE INNER SHEATH BECAUSE IT WOULD BE LONG ENOUGH. AS THEY WERE ADVANCING THE INNER SHEATH WITHOUT AND PROBLEMS WE NOTICED THAT THE DEVICE STARTED TO OPEN (AS IF WE WERE IN POSITION 2 BUT WE WERE STILL IN POSITION 1). IT APPEARED THAT THE INNER SHEATH COVER STARTED TO RIP. THE DISTAL END WAS STILL IN THE RIGHT ILIAC OTHERWISE HE WOULD HAVE BEEN ABLE TO SIMPLY DEPLOY. SINCE ONLY 1 STENT WAS OUT HE TRIED TO PULL THE DEVICE B

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 21327018 ↗

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