RelayPro Thoracic Stent-Graft System 28-N4-46-164-42URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576151024), received between Jun 17, 2025 and Jun 17, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Seal” (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.

• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Failure to Seal; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Failure to Seal

  "PARAPLEGIA / CEREBRAL INFARCTION AND NEUROPARALYSIS (POSSIBLE): A CUTDOWN TECHNIQUE WAS USED FOR THE FEMORAL ARTERY ON BOTH SIDES, AND THE LEFT BRACHIAL ARTERY WAS PUNCTURED. A SELECON CATHETER WAS USED AS A PROTECTION FOR THE LSA. PTA WAS PERFORMED IN THE RIGHT FA USING A LUNDERQUIST GUIDEWIRE (COOK) AND A SHIDEN CATHETER (KANEKA). A DRYSEAL (22 FR, GORE) WAS INSERTED AND DEEMED PASSABLE. A RELAY PRO STENT GRAFT (28-N4-36-109-36U) WAS IMPLANTED MATCHING WITH THE LOWER PORTION OF THE ANEURYSM. THE RELAY PRO STENT GRAFT CONCERNED (28-N4-46-209-42U) WAS THEN INSERTED AND DEPLOYED WITHOUT COVERING THE LSA. THE STENT GRAFT WAS IMPLANTED AND WAS SLIGHTLY OFF TO THE PERIPHERY. THE DELIVERY SYSTEM WAS THEN REMOVED AND THE DRYSEAL WAS INSERTED. BALLOONING WAS PERFORMED USING A TRI-LOBE BALLOON CATHETER (GORE). ANGIOGRAPHY WAS PERFORMED AND SHOWED A SLIGHT LEAK. IT WAS DECIDED THAT AN ADDITIONAL RELAY PRO STENT GRAFT (28-N4-46-164-42U) WOULD BE IMPLANTED AS THE THIRD STENT GRAFT. THE STENT GRAFT WAS IMPLANTED RIGHT BELOW THE LSA AND BALLOONING WAS ALSO PERFORMED. THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK AND NO DAMAGE TO THE ACCESS ROUTE. AFTER AWAKENING FROM THE ANESTHESIA, IT WAS CONFIRME

  Patient problems: Aneurysm expansion; Clinical Endoleak; Insufficient Information; Paraplegia; Stroke/CVA

  MAUDE report 22229498 ↗

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