RelayPro Thoracic Stent-Graft System 28-N4-34-154-34URecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00843576150607), received between Oct 16, 2024 and May 14, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Endoleak” (2 reports).

3 FDA recall records name this device's identifier, 2 still open.

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. Feb 22, 2024Class IICompleted

   The stent-graft inside the delivery system was the incorrect size.

   Z-1383-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Device Slipped; Device Endoleak

  ENDOLEAK (TYPE IB OR IIIB) A PATIENT IN WHOM THE RELAY PRO STENT GRAFT WAS IMPLANTED WAS BROUGHT TO THE HOSPITAL DUE TO SUSPECTED AORTA RUPTURE. SINCE A TYPE 1B OR TYPE 3B CAUSED BY MIGRATION WAS SUSPECTED BASED ON A CT SCAN, AN EMERGENCY TEVAR WAS PERFORMED. ANGIOGRAPHY DURING THE PROCEDURE ALSO SHOWED AN ENDOLEAK FLOWING INTO THE ANEURYSM. THEREFORE, THE PHYSICIAN ADDITIONALLY IMPLANTED A CTAG STENT GRAFT (GORE). AFTER IMPLANTING THE CTAG STENT GRAFT, THE ENDOLEAK DISAPPEARED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR: NO BLOOD LOSS, NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY, NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY, NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY, DELIVERY SYSTEM WAS DISCARDED BY USER, ((B)(4)). PATIENT OUTCOME: "NO HEALTH HAZARD TO THE PATIENT".

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25172568 ↗
• InjuryFeb 18, 2026Device Endoleak

  "ENDOLEAK (SUSPECTED TYPE IIIB) AND ENLARGED ANEURYSM: A PATIENT WHO HAD THE RELAY PRO STENT-GRAFT IMPLANTED ON (B)(6) 2024, UNDERWENT A FOLLOW-UP CT SCAN THIS MONTH, WHICH REVEALED AN ENDOLEAK IN THE ANEURYSM AND ENLARGEMENT OF THE ANEURYSM. THE ENDOLEAK WAS SUSPECTED OF BEING TYPE IIIB. NO ENDOLEAK WAS NOTED DURING AND AFTER THE PROCEDURE. THE PATIENT WILL UNDERGO ADDITIONAL TEVAR THIS MONTH, USING A STENT-GRAFT OF A DIFFERENT MODEL. PHYSICIAN'S COMMENT ON CAUSALITY: CAUSAL RELATIONSHIP WITH THE PRODUCT CANNOT BE RULED OUT. OPERATION TYPE: TEVAR NO BLOOD LOSS COMPLICATIONS: UNKNOWN MEDICAL HISTORY: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. (TC# (B)(4). PATIENT OUTCOME: "THE PATIENT'S OUTCOME IS UNKNOWN."

  Patient problems: Clinical Endoleak

  MAUDE report 24384018 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  "IS THIS EVENT RELATED TO A DEVICE FAILURE/DEFICIENCY? NO. THE SITE INITIALLY REPORTED THE EVENT OF " MYELOPATHY" IN THE STUDY DATABASE ON 17-DEC-2024. THE EVENT DESCRIPTION IS: "PATIENT HAD ONSET WEAKNESS OF LOWER EXTREMITIES". THE SITE RESPONDED "NO" TO THE QUESTION "WAS THE ADVERSE EVENT ASSOCIATED WITH A DEVICE DEFICIENCY?" THEREFORE, THE RESPONSE PROVIDED ABOVE IS BASED UPON THE SITES ASSESSMENT. THE SITE REPORTED THE EVENTS AS BEING NOT RELATED TO THE DEVICE, POSSIBLY RELATED TO THE PROCEDURE, AND RELATED TO A PRE-EXISTING CONDITION. THESE RESPONSES HAVE BEEN USED TO POPULATE THE QUESTIONS BELOW. PLEASE NOTE THAT THIS EVENT IS BEING REPORTED TO QA COMPLAINTS BASED UPON THE CLINICAL EVENT COMMITTEES (CECS) ADJUDICATION OF THE EVENT. THE CEC ADJUDICATED THIS EVENT AS BEING RELATED TO THE RELAY STENT-GRAFT. THE NAMSA SAFETY SPREADSHEET WHICH WAS SUBMITTED TO TA ON 09-DEC-25 HAS BEEN SUBMITTED TO QA COMPLAINTS SEPARATELY. WAS THIS EVENT AN ANTICIPATED/EXPECTED EVENT? YES. WAS SURGICAL INTERVENTION REQUIRED? NO. IS THIS EVENT RELATED TO THE PROCEDURE? POSSIBLY. IS THIS EVENT RELATED TO A PRE-EXISTING CONDITION? YES. THE FOLLOWING IMAGING IS AVAILABLE IN THE MEDIDATA DATABASE: PRE-

  Patient problems: Neuropathy; Paraplegia

  MAUDE report 24003881 ↗
• InjuryNov 12, 2025Mechanical Jam; Mechanical Jam

  "DEFECTIVE: AFTER ADVANCING THE INNER SHEATH, IT WAS FOUND THAT THE CONTROLLER COULD NOT BE TURNED FROM THE "1" POSITION. BASED ON THIS FINDING, IT WAS DETERMINED THAT THE IMPLEMENTATION OF THE RELAY PRO STENT GRAFT WOULD BE IMPOSSIBLE. THE DELIVERY SYSTEM WAS THEN REMOVED FROM THE PATIENT WITHOUT RETRACTING THE INNER SHEATH INTO THE OUTER SHEATH, WHICH RESULTED IN DAMAGE TO THE EIA. THE DAMAGED EIA WAS TREATED WITH A BARE STENT. THE PROCEDURE WAS THEN COMPLETED. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. ANCILLARY DEVICES USED: LUNDERQUIST GUIDEWIRE (COOK MEDICAL), CHECK-FLO SHEATH (18 FR, COOK MEDICAL), CODA BALLOON CATHETER (COOK MEDICAL.) ANCILLARY MEDICATIONS USED: HEPARIN, PROTAMINE. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE UPON REQUEST. ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST. TC# (B)(4). PATIENT OUTCOME: "THE PATIENT HAS RECOVERED."

  Patient problems: Laceration(s); Perforation

  MAUDE report 23535544 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  "SUBJECT PRESENTED A SACCULAR AORTIC ANEURYSM THAT WAS TREATED WITH A RELAYPRO NBS ON (B)(6) 2023. ON (B)(6) 2025, DURING THE 2Y FOLLOW-UP VISIT, A NEW FOCAL TEAR AND DISSECTION AT DISTAL EDGE OF TEVAR STENT. PI DETERMINED THIS NOT RELATED TO THE PROCEDURE BUT RELATED TO THE MAIN BODY OF DEVICE. " PATIENT OUTCOME: "PHYSICAN DISCUSSING INTERVENTION OR SURVEILLANCE. WILL UPDATE ACTION WHEN DECIDED."

  Patient problems: Vascular Dissection

  MAUDE report 23433188 ↗
• InjuryMay 16, 2025Material Separation; Separation Problem; Material Separation; Separation Problem

  "LEAKAGE OF BLOOD FROM THE CONTROLLER: THE RELAY PRO STENT GRAFT WAS USED FOR TEVAR. DURING INSERTION OF THE DELIVERY SYSTEM INTO THE ARTERY, BLOOD LEAKAGE WAS OBSERVED ON THE LEFT SIDE OF THE CONTROLLER. AS THE AMOUNT OF BLOOD LEAKAGE WAS SMALL (ONLY A SLIGHT DROP), IT WAS DETERMINED THAT THE LEAKAGE DID NOT AFFECT EITHER THE PROCEDURE OR THE PATIENT. THERE WAS NO PROBLEM WITH THE USE OF THE STENT GRAFT ITSELF. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR BLOOD LOSS: UNKNOWN ANCILLARY DEVICE USED: 28-N4-32-164-32U. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY PRE-CASE PLAN AVAILABLE UPON REQUEST NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. (TC#(B)(4)). PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22036172 ↗
• MalfunctionOct 16, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  "BROKEN/DEFECTIVE": WHEN THE RELAY PRO WAS UNPACKED, THERE WAS SOMETHING WRONG WITH THE RADIOPAQUE TIP OF THE OUTER SHEATH (DETAILS UNKNOWN). IT WAS DIFFICULT TO INSERT THE DELIVERY SYSTEM, BUT THE DELIVERY SYSTEM WAS INSERTED WITHOUT PROBLEMS. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER THE PROCEDURE, ANGIOGRAPHY OF THE LEG CONFIRMED THAT THERE WAS NO PROBLEM WITH THE ACTUAL USE OF THE PRODUCT. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY, NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY, NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY, DELIVERY SYSTEM WAS DISCARDED BY USER. (TC#: (B)(4)." PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466450 ↗