RelayPro Thoracic Stent-Graft System 28-N4-32-209-32URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843576150720), received between Jan 29, 2025 and Jan 7, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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.

• MalfunctionJan 7, 2026Retraction Problem

  "UNABLE TO DEPLOY: AS PER THE IFU, THE INNER SHEATH WAS ADVANCED OUT OF THE OUTER SHEATH WITH THE CONTROLLER IN THE "1" POSITION. THE DEPLOYMENT GRIP WAS THEN ROTATED COUNTERCLOCKWISE TO DEPLOY THE STENT-GRAFT WITH THE CONTROLLER IN THE "2" POSITION, BUT THE INNER SHEATH COULD NOT BE PULLED DOWN AND THE DEPLOYMENT GRIP JUST ROTATED WITHOUT ENGAGEMENT. THE DEPLOYMENT GRIP WAS ATTEMPTED TO BE PULLED DISTALLY BY PRESSING THE DISENGAGEMENT BUTTON, BUT IT WAS TOO STIFF TO PULL DOWN THE INNER SHEATH. AFTER THAT, THE CONTROLLER WAS TURNED TO THE "1" POSITION AGAIN TO ROTATE THE DEPLOYMENT GRIP, WHICH FUNCTIONED NORMALLY IN THAT CONDITION. THE CONTROLLER WAS THEN TURNED TO THE "2" POSITION AND THE DEPLOYMENT GRIP WAS ROTATED TO DEPLOY THE STENT-GRAFT, BUT THERE WAS NO RESPONSE. HOWEVER, AFTER ROTATING THE DEPLOYMENT GRIP FOR A WHILE, THE INNER SHEATH BEGAN TO PULL DOWN, PROBABLY BECAUSE THE GEARS ENGAGED. AFTER THAT, THE STENT-GRAFT WAS DEPLOYED AND IMPLANTED USING THE STANDARD METHOD, AND THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. OPERATION TYPE: TEVAR. BLOOD LOSS: SMALL AMOUNT. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE (SEE THE ATTACHED SCHEMA). ADDITIONAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996549 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Failure to Seal; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Failure to Seal

  "TYPE IV ENDOLEAK AND DISSECTION: THE RELAY PRO STENT-GRAFT WAS IMPLANTED TO TREAT A DESCENDING AORTIC ANEURYSM. THE FINAL ANGIOGRAPHY SHOWED A LEAKAGE IN THE ANEURYSM, WHICH WAS CONSIDERED TO BE A TYPE IV BASED ON THE TIMING AND VOLUME (ABOUT ACT400). AS A PRECAUTION, POST DILATATION WAS PERFORMED USING A TRI-LOBE BALLOON CATHETER (GORE), AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, POSTOPERATIVE CT REVEALED AORTIC DISSECTION (FALSE LUMEN OCCLUSION), WHICH WAS NOT PRESENT BEFORE THE PROCEDURE. THE DISSECTION EXTENDED FROM NEAR THE AORTIC ARCH TO JUST BEYOND THE DISTAL OF THE STENT-GRAFT. THE FALSE LUMEN IS OCCLUDED AND THERE ARE NO PROBLEMS. THE PATIENT IS BEING FOLLOWED UP. AS THE LOCATION OF THE ENTRY IS UNKNOWN, THE TIMING AND CAUSE OF THE OCCURRENCE ARE UNKNOWN. HOWEVER, SINCE THE FINAL ANGIOGRAPHY SHOWED NO PROBLEMS AND CLEARLY SHOWED THE INTERCOSTAL ARTERY, IT IS CONSIDERED THAT THE DISSECTION MAY HAVE BEEN OCCURRED AFTER THE PROCEDURE. OPERATION TYPE: STENT-GRAFT IMPLEMENTATION. NO BLOOD LOSS. ANCILLARY DEVICE USED: TRI-LOBE BALLOON CATHETER (GORE). NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE. ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAIN

  Patient problems: Clinical Endoleak; Insufficient Information; Vascular Dissection

  MAUDE report 22161644 ↗
• MalfunctionMar 26, 2025Ejection Problem; Difficult or Delayed Separation; Ejection Problem; Difficult or Delayed Separation

  "DURING STEP 3 OF THE DEPLOYMENT, PHYSICIAN RETRACTED THE BLACK GRIP OVER THE GRAY GRIP AND THE PROXIMAL CLASP DID NOT RELEASE. EXCESSIVE FORCE WAS REQUIRED TO DEPLOY. IT FINALLY DEPLOYED AFTER MULTIPLE ATTEMPTS." PATIENT OUTCOME: "GOOD PATIENT OUTCOME. NO COMPLICATIONS RELATED TO DEVICE MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701639 ↗
• MalfunctionJan 29, 2025Mechanical Problem; Failure to Advance; Difficult to Advance; Difficult or Delayed Separation; Mechanical Problem; Failure to Advance; Difficult to Advance; Difficult or Delayed Separation

  "DEVICE WAS PREPPED IN THE USUAL FASHION BY FLUSHING WIRE PORT AND MAIN STENT PORT AND WIPING DOWN SHEATH OUT OF THE BOX. THE DEVICE WAS THEN INSERTED BARE BACK FROM THE FEMORAL ARTERY IN THE NORMAL FASHION UP TO THE DISTAL LANDING ZONE. THE DEVICE WAS ON NUMBER 1 THEN ADVANCED UP USING CLOCKWISE ROTATION OF MECHANICAL ADVANTAGE AND INTO THE PRIOR RELAY STENT PLACED DURING PRIOR FET WITH NO ISSUES. THE LANDING ZONE WAS SELECTED AND AGREED,THE DEVICE WAS PLACED IN NUMBER 2 AND THE MECHANICAL ADVANTAGE WAS THEN ROTATED COUNTER CLOCKWISE TO LINE UP THE D MARKER WITH THE OVERLAP MARKER OF THE STENT. DURING THIS MOVEMENT IN NUMBER 2 THE MECHANICAL ADVANTAGED FAILED AND JUST SPUN AS IF THE GEARS WOULDN'T CATCH. PLACED BACK IN NUMBER 1, THEN BACK IN NUMBER 2 AND ONCE AGAIN THE MECHANICAL ADVANTAGE JUST ROTATED WITHOUT ENGAGING THE GEAR AND JUST SPUN NOT ALLOWING THE D MARKER TO MOVE. WE THEN JUST PROCEEDED TO DEPLOY THE DEVICE IN NUMBER 2 BY PUSHING THE BLACK BUTTON AND SLIDING IT TO THE REAR OF THE DEVICE. THIS MOVEMENT WORKED BUT WAS NOT SMOOTH IN DEPLOYING THE DEVICE. WE THEN PROCEEDED TO CONTINUE THE REST OF DEPLOYMENT, POSITION 3 WAS THEN USED TO RELEASE SENT AND NUMBER 4 WAS PLACED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264921 ↗

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