RelayPro Thoracic Stent-Graft System 28-M4-34-145-34URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843576149786), received between Oct 2, 2024 and Dec 20, 2024 — classified as 2 injuries, 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls 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. Dec 20, 2022Class IIOpen, Classified

   The product may be shorter than packaging indicates

   Z-0997-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• InjuryDec 20, 2024Device Endoleak; Device Endoleak

  "ENDOLEAK (MINOR TYPE IA ENDOLEAK REMAINED): ONLY 2-DEBRANCHING WAS PERFORMED ON NOVEMBER 15, AND TEVAR WAS THEN PERFORMED ON NOVEMBER 22. AS THE ACCESS ARTERY COULD NOT BE PUNCTURED DUE TO ITS POOR CONDITION, A CUT-DOWN METHOD WAS USED INSTEAD. TEVAR WAS THEN PERFORMED AS USUAL. AS A 200 MM LONG STENT-GRAFT WOULD BE TOO LONG, TWO 150 MM LONG STENT-GRAFTS WERE USED. THE STENT-GRAFT CONCERNED (28-M4-34-145-34U, LOT#2406220121) WAS FIRST IMPLANTED FROM RIGHT UNDER ZONE 1, AND THE SECOND STENT-GRAFT (28-M4-34-145-34U, LOT#2407190457) WAS THEN IMPLANTED RIGHT ABOVE A DESCENDING THORACIC AORTIC ANEURYSM ON THE DISTAL SIDE. THE FINAL ANGIOGRAPHY REVEALED A TYPE IA ENDOLEAK. AFTER CAREFUL POST DILATATION, ANOTHER ANGIOGRAPHY CONFIRMED THAT A SLIGHT TYPE IA ENDOLEAK REMAINED. SINCE THE DESCENDING THORACIC AORTIC ANEURYSM ON THE DISTAL SIDE IS GOING TO BE TREATED IN THE NEAR FUTURE, THIS PROCEDURE WAS COMPLETED AND THE PATIENT WAS TO BE FOLLOWED UP. ADDITIONAL INFORMATION OBTAINED ON NOVEMBER 27: CONTRAST-ENHANCED CT CONFIRMED ON NOVEMBER 26 THAT THE ENDOLEAK HAD DISAPPEARED OPERATION TYPE: 2-DEBRANCHING TEVAR BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVA

  Patient problems: Clinical Endoleak

  MAUDE report 20989450 ↗
• InjuryDec 20, 2024Device Endoleak; Device Endoleak

  "ENDOLEAK (MINOR TYPE IA ENDOLEAK REMAINED): ONLY 2-DEBRANCHING WAS PERFORMED ON NOVEMBER 15, AND TEVAR WAS THEN PERFORMED ON NOVEMBER 22. AS THE ACCESS ARTERY COULD NOT BE PUNCTURED DUE TO ITS POOR CONDITION, A CUT-DOWN METHOD WAS USED INSTEAD. TEVAR WAS THEN PERFORMED AS USUAL. AS A 200 MM LONG STENT-GRAFT WOULD BE TOO LONG, TWO 150 MM LONG STENT-GRAFTS WERE USED. THE STENT-GRAFT CONCERNED (28-M4-34-145-34U, LOT#2406220121) WAS FIRST IMPLANTED FROM RIGHT UNDER ZONE 1, AND THE SECOND STENT-GRAFT (28-M4-34-145-34U, LOT#2407190457) WAS THEN IMPLANTED RIGHT ABOVE A DESCENDING THORACIC AORTIC ANEURYSM ON THE DISTAL SIDE. THE FINAL ANGIOGRAPHY REVEALED A TYPE IA ENDOLEAK. AFTER CAREFUL POST DILATATION, ANOTHER ANGIOGRAPHY CONFIRMED THAT A SLIGHT TYPE IA ENDOLEAK REMAINED. SINCE THE DESCENDING THORACIC AORTIC ANEURYSM ON THE DISTAL SIDE IS GOING TO BE TREATED IN THE NEAR FUTURE, THIS PROCEDURE WAS COMPLETED AND THE PATIENT WAS TO BE FOLLOWED UP. ADDITIONAL INFORMATION OBTAINED ON NOVEMBER 27: CONTRAST-ENHANCED CT CONFIRMED ON NOVEMBER 26 THAT THE ENDOLEAK HAD DISAPPEARED OPERATION TYPE: 2-DEBRANCHING TEVAR. BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AV

  Patient problems: Clinical Endoleak

  MAUDE report 20989433 ↗
• MalfunctionOct 2, 2024Difficult to Advance; Difficult or Delayed Separation; Difficult to Advance; Difficult or Delayed Separation

  "UNABLE TO ADVANCE THE INNER SHEATH: WHEN THE SALES REPRESENTATIVE ENTERED THE OPERATION ROOM, THE PHYSICIAN HAD ADVANCED THE DELIVERY SYSTEM TO THE LEFT SUBCLAVIAN ARTERY AND WAS ATTEMPTING TO DEPLOY THE STENT GRAFT WITH THE CONTROLLER PLACED IN POSITION "2". HOWEVER, THE SALES REPRESENTATIVE OBSERVED THAT ALTHOUGH THE DEPLOYMENT GRIP HAD ADVANCED PAST THE ARROW MARKER AND WAS SO CLOSE TO THE CONTROLLER THAT THERE WAS ALMOST NO DISTANCE TO THE CONTROLLER, THE INNER SHEATH HAD ONLY EXTENDED ONE STENT LENGTH OUT OF THE OUTER SHEATH. WHILE PRESSING THE DISENGAGEMENT BUTTON, THE REVERSE SLIDER TECHNIQUE WAS ATTEMPTED, BUT THE OUTER SHEATH WAS UNABLE TO BE RETRACTED. ROTATING THE DEPLOYMENT GRIP CLOCKWISE WAS ABLE TO ONLY PARTIALLY ADVANCE THE INNER SHEATH, LEAVING THREE STENT LENGTH OF INNER SHEATH REMAINING IN THE OUTER SHEATH, AND ALSO LEAVING NO SPACE BETWEEN THE CONTROLLER AND THE DEPLOYMENT GRIP FOR FURTHER MANIPULATION. THE CONTROLLER WAS PLACED IN THE "4" POSITION AND THE STAINLESS-STEEL ROD WAS PUSHED, BUT THE INNER SHEATH WAS UNABLE TO BE MOVED. SINCE THE REVERSE SLIDE TECHNIQUE WAS INEFFECTIVE, IT WAS DETERMINED THAT THERE WAS NO ALTERNATIVE BUT TO TURN THE DEPLOYMENT GRIP A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354220 ↗

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-2160-2026 · Apr 22, 2026 · Open, Classified
  RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-
• 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