RelayPro Thoracic Stent-Graft System 28-N4-40-154-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576150997), received between Nov 20, 2024 and Jan 29, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Retraction Problem

  "22F DRY SEAL WAS INSERTED PRIOR TO RELAY PRO DELIVERY. THE RELAY PRO DEVICE WAS DELIVERED TO THE INTENDED SEGMENT OF THE AORTA. IN STEP 1 WE UNSHEATHED THE DEVICE. WE TURNED IT TO STEP 2; DR (B)(6) STARTED TO TURN THE GRAY HANDLE AND FELT STRONG RESISTANCE IN THE HANDLE. I CONFIRMED THAT HE WAS TURNING THE HANDLE IN THE CORRECT POSITION. HE SAID THERE WAS TOO MUCH RESISTANCE (DR (B)(6) HAS DEPLOYED OVER 50 RELAY PROS AND KNOWS THE APPROPRIATE EFFORT REQUIRED). WE PULLED THE DEVICE OUT OF THE BODY WITH NO ATTEMPT TO RECAPTURE IT INTO STEP 1, SINCE WE WERE PULLING IT OUT THROUGH A DRY SEAL SHEATH, SO NO INJURY WAS DONE TO THE VESSELS." PATIENT OUTCOME: "NONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210303 ↗
• MalfunctionNov 20, 2024Material Separation; Separation Problem; Material Separation; Separation Problem

  "THE 40/36X754 RELAY PRO NBS WAS PREPPED FOLLOWING IFU INSTRUCTIONS. THE DEVICE WAS PUT INTO POSITION IN OVER AN 0.35 LUNDERQUIST WIRE IN THE DESCENDING THORACIC AORTA. DR. (B)(6) CONFIRMED THE DELIVERY SYSTEM WAS IN POSITION 1 AND BEGAN TURNING THE DEPLOYMENT GRIP CLOCKWISE. AFTER 2 OR 3 TURNS OF THE DEPLOYMENT GRIP, A "CRACK"/"POP" NOISE WAS HEARD, SEEMING TO COME FROM THE CONTROLLER KNOB/GREY GRIP AREA. DR. (B)(6) ANNOUNCED HE HEARD A "POP" NOISE. THE DEVICE APPEARED TO BE UNAFFECTED VISUALLY. DR. (B)(6) CONTINUED TO ADVANCE THE INNER SHEATH OUT OF THE OUTER SHEATH IN NORMAL FASHION UNTIL THE GRAFT WAS IN POSITION. WHEN DR. (B)(6) WENT TO CHANGE TO POSITION 2 ON THE CONTROL KNOB, BLOOD WAS NOTICED COMING OUT OF THE DELIVERY SYSTEM IN THE ADVANCEMENT INDICATOR AREA. DR. (B)(6) DEPLOYED THE ENDOGRAFT WITHOUT ISSUE BUT NOTICED ABOUT 100CC BLOOD LOSS." PATIENT OUTCOME: "THE RELAY PRO NBS 40/36X154 WAS DEPLOYED SUCCESSFULLY. THE DELIVERY SYSTEM WORKED TO DEPLOYED AND REMOVE WITHOUT ISSUE A UNIT OF BLOOD WAS ORDERED FOR THE PATIENT."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20735168 ↗

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