RelayPro Thoracic Stent-Graft System 28-N4-42-159-38URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843576151000), received between Nov 20, 2024 and Mar 12, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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

• InjuryMar 12, 2026Material Invagination; Material Deformation; No Apparent Adverse Event

  "ON FOLLOW UP CT THE DEVICE HAS INVAGINATED AT THE PROXIMAL EDGE. PRE AND POST OP IMAGING WILL BE PROVIDED." PATIENT OUTCOME: "THIS WAS FOUND ON ROUTINE F/U CT, PATIENT IS STABLE. NO ADDITIONAL TREATMENT HAS BEEN DONE YET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584378 ↗
• InjuryFeb 14, 2026Material Invagination; Material Deformation; No Apparent Adverse Event

  "ON FOLLOW UP CT, THE DEVICE HAS INVAGINATED AND IS NO LONGER SEALING THE DISSECTION. PRE AND POST OP IMAGING WILL BE PROVIDED." PATIENT OUTCOME: "THIS WAS FOUND ON ROUTING F/U CT, PATIENT IS STABLE. NO ADDITIONAL TREATMENT HAS BEEN DONE YET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340442 ↗
• MalfunctionNov 20, 2024Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  "DURING POST STENT DEPLOYMENT IN ZONE ¾ OF THE THORACIC AORTA THE PATIENT LOOKED TO HAVE A PRIOR POST ELEPHANT TRUNK. POST DEPLOYMENT OF RELAY PRO STENT WAS SUCCESSFUL IN ZONE ¾ , BUT RECAPTURING THE TIP (NOSE CONE) SEEMED TO BE DIFFICULT DUE TO THE ANGLE OF ANATOMY AND POST SURGICAL INTERVENTION FROM PRIOR REPAIR. SEVERAL ATTEMPTS WHERE MADE TO CAPTURE THE TIP (NOSE CONE) AND AFTER A FEW TRIES WE WERE ABLE TO SUCCESSFULLY MARRY THE NOSE CONE TO THE OUTER SHEATH PER IFU. NO SHEATH WAS USED DURING THE CASE, THE VESSELS WHERE DILATED USING TRADITIONAL DILATION TECHNIQUE USING MULTIPLE DILATORS. THE DEVICE WAS PULLED DOWN TO THE LEVEL OF THE LEFT ACCESS ARTERIOTOMY (LCFA 9.4MM) AND AT THAT POINT WAS READY TO BE REMOVED OVER A STIFF WIRE. IN THE PROCESS OF THIS ACTION, AS THE DEVICE WAS BEING PULLED THROUGH THE ARTERIOTOMY SITE; THE TIP (NOSE CONE) WAS DETACHED FROM THE MAIN DEVICE AND STAYED IN THE ARTERY." PATIENT OUTCOME: "PATIENT NEEDED CUT DOWN TO REMOVE THE TIP (NOSE CONE) FROM THE ARTERY."

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

  MAUDE report 20738050 ↗

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