RelayPro Thoracic Stent-Graft System 28-N4-36-259-36URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576150874), received between Sep 25, 2024 and Sep 25, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

1 FDA recall record name this device's identifier, 1 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 ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation

  "PHYSICIAN CHOSE 36-100 GRAFT TO LAND AT LSA. INTRODUCED GRAFT ONTO THE WIRE IN POSITION 1, ADVANCED PROXIMAL OUTER SHEATH/TIP TO DISTAL LANDING ZONE. THEN ADVANCED INNER SHEATH TO LSA WHICH IS THE PROX LANDING ZONE. PUT CONTROLLER KNOB IN POSITION 2. HAD RESIDENT TURN THE DEPLOYMENT GRIP COUNTERCLOCKWISE TO UNSHEATH THE FIRST COVERED STENT. THE RESIDENT CONTINUED TO TURN THE DEPLOYMENT GRIP BUT NOTHING MOVED. AT THE SAME TIME THE DEPLOYMENT GRIP BUTTON WAS DEPRESSED. WE TRIED DIFFERENT TROUBLESHOOTING TECHNIQUES AND CONTINUED TO TRY TO UNSHEATH THE INNER SHEATH BUT NOTHING MOVED. FINALLY, DR (B)(6) SCRUBBED IN, MOVED THE DISENGAGEMENT BUTTON A FEW TIMES, TRIED TO ROTATE THE DEPLOYMENT GRIP WITH NO LUCK, THEN PUSHED THE BUTTON DOWN AND PULLLED BACK WITH SOME FORCE TO DEPLOY THE GRAFT. WHEN THE RESIDENT WENT TO STEP3 TO RELEASE THE GRAFT FROM THE DEPLOYMENT SYSTEM IT WOULD LOCK IN PLACE SO WE HELD THEM TOGETHER WHILE RETRACTING THE TIP BACK INTO THE SHEATH. GRAFT IS IN BIOHAZARD BAG AT THE HOSPITAL WAITING FOR THE REP TO COME BACK FROM VACATION TO RETURN IT. REP NAME (B)(6). UPDATE OF EVENT NARRATIVE (RECEIVED ON 09/23/2024): WE ARE INITIATING AN ADDITIONAL COMPLAINT FOR THE FIRST R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300497 ↗

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