RelayPro Thoracic Stent-Graft System 28-N4-32-164-32URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843576150591), received between Jun 13, 2024 and Aug 1, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2025Failure to Advance; Failure to Advance

  "THE SURGEON ATTEMPTED TO ADVANCE A 32X164 NBS RELAY PRO TO THE PROXIMAL LANDING ZONE. TORTUOUS DESCENDING AORTIC ANATOMY AND PROXIMAL ANGULAR GOTHIC ARCH ANATOMY APPEARED TO LIMIT THE DEVICE'S ABILITY TO REACH THE DESIRED LANDING ZONE. THE DEVICE WOULD NOT ADVANCE, AND THE WIRE WAS STUCK IN THE DELIVERY SYSTEM, (WOULD NOT ADVANCE OR RETRACT). THE SURGEON WAS FORCED TO REMOVE THE DEVICE. UPON INSPECTION THE PROXIMAL ASPECT OF THE DELIVERY SYSTEM WAS DAMAGED AT THE JUNCTION OF THE NOSE CONE AND DELIVERY SYSTEM. THE MID PORTION OF THE OUTER SHEATH WAS "ACCORDIONED", AS WAS THE DISTAL ASPECT OF THE OUTER SHEATH. THE STIFF WIRE WAS AGAIN ADVANCED JUST PROXIMAL TO THE AORTIC VALVE. A SECOND DEVICE WAS ATTEMPTED (32X104 NBS). SIMILAR RESULTS OCCURRED WITH SIGNIFICANT DAMAGE AGAIN OCCURRING TO THE DELIVERY SYSTEM. THE WIRE AGAIN WAS TRAPPED IN THE DELIVERY SYSTEM UNABLE TO RETRACT OR ADVANCE." PATIENT OUTCOME: "TEVAR COMPLETED WITH GORE CTAG PROXIMALLY AND A TERUMO AORTIC RELAY PRO EXTENDED DISTALLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22692176 ↗
• InjuryMay 22, 2025Separation Failure; Failure to Eject; Separation Failure; Failure to Eject

  "UNABLE TO DEPLOY THE STENT GRAFT: DURING DEPLOYMENT OF THE STENT-GRAFT AS USUAL, THE APEX HOLDER KNOB COULD NOT BE PULLED WITH THE CONTROLLER IN THE "3" POSITION. ALTHOUGH THE PHYSICIAN PULLED THE APEX HOLDER KNOB, IT ONLY APPLIED TENSION. WHEN THE PHYSICIAN REMOVED HIS HAND FROM THE APEX HOLDER KNOB, IT RETURNED TO ITS ORIGINAL POSITION. (WHEN PULLING THE INNER SHEATH WITH THE CONTROLLER IN THE "2" POSITION, THE PHYSICIAN FIRST FELT SOMETHING CAUGHT. WHEN THE STENT-GRAFT WAS ATTEMPTED TO BE DEPLOYED, THE INNER SHEATH DID NOT MOVE; HOWEVER, THE INNER SHEATH WAS PULLED AT ONCE AS IF SOMETHING CAUGHT HAD BEEN REMOVED. AS SOON AS ONE STENT OF THE STENT-GRAFT WAS DEPLOYED, THE ENTIRE STENT-GRAFT WAS DEPLOYED TO THE DISTAL END; THEREFORE, THE POSITION TO BE IMPLANTED ON THE PROXIMAL SIDE WAS AS INTENDED.) THE PHYSICIAN TRIED EVERYTHING HE COULD WITH MANIPULATION OF THE DELIVERY SYSTEM. DILATATION USING A BALLOON CATHETER TO STIMULATE EXTERNALLY DID NOT WORK AT ALL. USING ANOTHER STENT-GRAFT (STOCK), THE PHYSICIAN ATTEMPTED SEVERAL TIMES TO DIRECTLY PULL THE GREEN TUBE. HOWEVER, AS IT WAS PRACTICALLY DIFFICULT AND WOULD RESULT IN AN UNCOLLECTIBLE SITUATION IF THE DEVICE WAS BROKEN, THE

  Patient problems: Paresis

  MAUDE report 22070004 ↗
• MalfunctionSep 12, 2024Difficult to Insert; Failure to Advance; Material Deformation; Difficult to Insert; Failure to Advance; Material Deformation

  "TIP OF THE OUTER SHEATH WAS DEFORMED: TREATMENT WAS PLANNED VIA PERCUTANEOUS APPROACH. SEVERAL PERCLOSES WERE PUT IN AND THEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE INSERTED INTO THE ARTERY. HOWEVER, THE DELIVERY SYSTEM ENCOUNTERED RESISTANCE AND INSERTION WAS ABORTED. INSPECTION OF THE DELIVERY SYSTEM REVEALED THAT THE TIP OF THE OUTER SHEATH WAS DEFORMED. IT WAS UNCLEAR WHETHER THE OUTER SHEATH WAS DEFORMED BEFORE INSERTION OR DURING INSERTION. THE DELIVERY SYSTEM WAS RE-INSERTED USING AN INTRODUCER SHEATH (DRYSEAL, GORE). INSERTION WAS SUCCESSFUL. HOWEVER, THE SYSTEM WAS UNABLE TO REACH THE TARGET LANDING ZONE. USE OF THE DELIVERY SYSTEM WAS THEREFORE ABORTED. AS THE INNER SHEATH WAS ALREADY ADVANCED OUT OF THE OUTER SHEATH, THE PROCEDURE WAS CHANGED TO SURGICAL CUT-DOWN AND THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT TOGETHER WITH THE DRYSEAL. THE PROCEDURE WAS CONTINUED USING A COMPETITOR'S STENT-GRAFT SYSTEM (VALIANT CAPTIVIA, MEDRONIC) AND ITS STENT-GRAFT WAS SUCCESSFULLY IMPLANTED. PHYSICIAN'S COMMENT: THE PHYSICIAN REQUESTED US TO CHECK IF THERE HAVE BEEN ANY REPORTS OF DEFORMATION OF THE TIP OF THE OUTER SHEATH. OPERATION TYPE: TEVAR IMAGE AVAILABLE NO PRE-CASE PLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200025 ↗
• MalfunctionJun 13, 2024

  MIDDLE-AGED FEMALE WITH HISTORY OF ACUTE TYPE A AORTIC DISSECTION STATUS POST ASCENDING AND HEMIARCH AORTIC REPAIR ALONG WITH ANTEGRADE THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) AND LEFT SUBCLAVIAN STENTING, WHO PRESENTED WITH EXTREMELY LARGE AORTIC ARCH AND DESCENDING AORTIC ANEURYSM ASSOCIATED WITH THE RESIDUAL TYPE B AORTIC DISSECTION, PRESENTED FOR TEVAR PROCEDURE. DURING THE PROCEDURE, THE GRAFT WAS DEPLOYED AND AS THE MAIN STENT GRAFT SYSTEM CAME OUT FROM THE RIGHT FEMORAL ARTERY, THE NOSE CONE WAS SEPARATED FROM THE DEVICE. IT WAS LEFT IN THE EXTERNAL ILIAC ARTERY. THE RIGHT FEMORAL ACCESS WAS UPSIZED TO 24 FR AND 10 MM SNARE RETRIEVAL WAS EMPLOYED. THE NOSE CONE WAS ABLE TO BE RETRIEVED WITHOUT MAJOR ISSUES. MANUFACTURER RESPONSE FOR THORACIC STENT SYSTEM, TERUMO (PER SITE REPORTER). THEY STATED AN INSPECTION OF THE THREAD ON THE DISTAL INDICATED FOUND THAT THE EPOXY APPLICATION WAS IN THE INCORRECT LOCATION AND WAS NOT UNIFORMLY ALL THE WAY AROUND. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE OF THE TIP SEPARATING FROM THE DELIVERY SYSTEM WAS NOT PROCEDURE COMPLIANCE. THE OPERATORS DID NOT COMPLY TO THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19527552 ↗

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