RelayPro Thoracic Stent-Graft System 28-N4-38-259-34URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576151185), received between Sep 9, 2025 and Sep 15, 2025 — classified as 1 injury, 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.

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-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.

• MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  "RELAY PRO NBS 28-N4-38-259-34U. DEVICE WENT UP "BAREBACK" OVER 260 LUNDERQUIST WIRE ON THE PATIENT'S RIGHT SIDE VIA PERCUTANEOUS FEMORAL ACCESS. GRAFT WAS THEN SUCCESSFULLY DEPLOYED THROUGH EACH STEP 1-4 AND BACK TO 2 FOR REMOVAL. UPON REMOVAL OF THE DEVICE THE RUBBER TIP OF THE CATHETER CAME OFF AT THE PATIENT'S ARTERIOTOMY ON WITHDRAWAL. THE SURGEON THEN HAD TO ACCESS THE OTHER SIDE AND TRIED TO SNARE THE TIP. SNARING WAS UNSUCCESSFUL SO THEY HAD TO CUT DOWN ON THE RIGHT SIDE TO REMOVE THE TIP." PATIENT OUTCOME: "CUT DOWN TO RIGHT COMMON FEMORAL ARTERY AS A RESULT OF THE DISLODGED TIP. SOME ADDITIONAL ISCHEMIA TIME BECAUSE OF THE TIP OCCLUDING PART OF THE COMMON FEMORAL."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057540 ↗
• InjurySep 9, 2025Retraction Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Device Stenosis; Retraction Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Device Stenosis

  "PATIENT HAD PREVIOUS OPEN REPAIR AND HAD DACRON GRAFT SEWN INTO PROX PORTION OF DESCENDING THORACIC AORTA (DTA). WE WENT IN WITH 28-N4-38-259-34U RELAY PRO OVER A LUNDERQUIST WIRE. WENT UP "BAREBACK" WITH OUTER SHEATH ADVANCED JUST PAST VISCERAL ARTERIES. IN STEP 1, THE INNER SHEATH AND DEVICE WAS ADVANCED TO THE PROX LANDING ZONE WITHIN THE DTA. THERE WAS SOME MILD TORTUOSITY AND THE GRAFT WOULD NOT ADVANCE AS FAR UP AS DR NASLUND & DR GARRARD WANTED, HOWEVER, HE GOT IT IN A GOOD POSITION. HE THEN MOVED TO STEP 2 TO DEPLOY THE GRAFT AND THE INNER SHEATH WOULD NOT RETRACT. HE TRIED MULTIPLE TIMES GOING BACK TO STEP ONE AND THEN BACK TO STEP 2. HE THEN DEPRESSED THE BLACK, QUICK RELEASE BUTTON AND ATTEMPTED TO PULL THE INNER SHEATH BACK THAT WAY BUT IT WOULD NOT DEPLOY THE GRAFT THAT WAY EITHER. HE COULD FEEL RESISTANCE WITH EACH ATTEMPT TO RETRACT THE INNER SHEATH. AFTER MULTIPLE ATTEMPTS, HE DECIDED THAT HE WANTED TO GET THE DEVICE OUT OF THE BODY SINCE IT WASN'T RESPONDING CORRECTLY. HE ATTEMPTED TO GET THE DEVICE BACK INTO THE OUTER SHEATH BUT IT WOULD NOT GO BACK IN. HE THEN DECIDED TO REMOVE THE WHOLE SYSTEM FROM THE PATIENT. HE PULLED THE GRAFT (STILL INSIDE THE INNER SHEA

  Patient problems: Aortic dissection; Failure of Implant; Perforation of Vessels

  MAUDE report 23008571 ↗

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