TREO Abdominal Stent-Graft System 28-B2-24-100URecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843576152427), received between Mar 6, 2025 and Feb 24, 2026 — classified as 2 injuries, 3 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (P190015); 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Device Endoleak

  "SIZED CORRECTLY, GOOD ANATOMY, DISTAL TYPE 1B ENDO LEAK. BALLOONED MULTIPLE TIMES BUT DIDN'T GO AWAY." PATIENT OUTCOME: "PATIENT IS FINE. THEY WILL PERFORM A FOLLOW UP CT TO SEE IF THE LEAK GOES AWAY ONCE THEY REVERSE THE HEPARIN."

  Patient problems: Clinical Endoleak

  MAUDE report 24428773 ↗
• MalfunctionNov 11, 2025Fracture; Fracture

  "ON (B)(6) 2025, THE CORE LAB SENT A SIGNIFICANT FINDING NOTIFICATION REGARDING SUBJECT TPA-056-003'S 4-YEAR X-RAY DATED (B)(6) 2025 REFLECTING A STENT FRACTURE AT THE PROXIMAL ASPECT OF THE STENT. THE FOLLOWING DAY ON (B)(6) 2025, THE CORE LAB PROVIDED A 2ND NOTIFICATION THAT THE CORE LAB PI FURTHER CONFIRMED THE FRACTURE WAS ALSO PRESENT ON THE 3-YEAR IMAGING DATED (B)(6) 2024. PENDING FURTHER SITE DETAILS." PATIENT OUTCOME: "PENDING FURTHER SITE DETAILS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523162 ↗
• MalfunctionSep 15, 2025Separation Failure; Difficult or Delayed Separation; Separation Failure; Difficult or Delayed Separation

  "UNABLE TO DEPLOY THE STENT GRAFT: AFTER DEPLOYING THE CONTRALATERAL GATE OF THE STENT-GRAFT, THE PHYSICIAN ATTEMPTED TO PULL THE RELEASE GRIP TOWARDS THE DISTAL SIDE TO RELEASE THE BARE STENT. ALTHOUGH THE RELEASE GRIP WAS UNLOCKED, THE RELEASE GRIP DID NOT MOVE TOWARDS THE DISTAL SIDE, AND THE BARE STENT COULD NOT BE RELEASED. THE FOUR SCREWS OF THE RELEASE GRIP WERE REMOVED USING A HEX WRENCH, AND THE SLOT OF THE STAINLESS-STEEL ROD WAS WIDENED USING PLIERS. THE BARE STENT WAS THEN RELEASED TOWARDS THE DISTAL SIDE BY PINCHING THE GREEN TUBE USING FORCEPS. PHYSICIAN'S COMMENT: WHEN THE RELEASE GRIP WAS UNLOCKED, THE STAINLESS-STEEL ROD MAY HAVE BENT. (FROM THE MANUFACTURER'S POINT OF VIEW, THE STAINLESS-STEEL ROD DID NOT APPEAR TO BE BENT IN APPEARANCE.) OPERATION TYPE: EVAR. NO BLOOD LOSS. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED. (TC#(B)(4))". PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057536 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  "ENDOLEAK TYPE III B: AN ENDOLEAK WAS OBSERVED AT THE BIFURCATION PART OF THE MAIN BIFURCATED STENT-GRAFT AFTER THE TREO STENT GRAFT SYSTEM WAS IMPLANTED. IT WAS PRESUMED TO BE AN ENDOLEAK TYPE III B FROM A PIT HOLE. THE RIGHT LEG WAS OCCLUDED WITH A BALLOON, AND THEN ANGIOGRAPHY WAS PERFORMED TO DETERMINE WHICH LEG JUNCTION THE LEAK WAS ORIGINATING FROM. THIS REVEALED THAT THE LEAK WAS OCCURRING AT THE BIFURCATION PART OF THE LEFT LEG OF THE MAIN BIFURCATED STENT-GRAFT. AN ADDITIONAL LEG EXTENSION STENT-GRAFT WAS IMPLANTED INSIDE THE PREVIOUSLY IMPLANTED LEFT LEG EXTENSION STENT-GRAFT, AND ANGIOGRAPHY WAS PERFORMED, BUT THE LEAK WAS NOT RESOLVED. THE PHYSICIAN DECIDED TO OBSERVE THE PATIENT AS THE LEAK MIGHT STOP WITH THE ADMINISTRATION OF PROTAMINE. OPERATION TYPE: EVAR ANCILLARY DEVICES USED: 2 X 28-L2-15-100U, 28-L2-15-080U BLOOD LOSS: AMOUNT IS UNKNOWN. IMAGE AVAILABLE: IMAGES ATTACHED PRE-CASE PLAN AVAILABLE: SCHEMA ATTACHED. ADDITIONAL INFORMATION AVAILABLE UPON REQUEST. (TC# BM250501295)". PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: Clinical Endoleak; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170820 ↗
• MalfunctionMar 6, 2025Mechanical Jam; Mechanical Jam

  "UNABLE TO DEPLOY THE STENT GRAFT: AFTER THE MAIN BIFURCATED STENT-GRAFT WAS DEPLOYED AS PER IFU, THE PHYSICIAN ATTEMPTED TO DEPLOY THE BARE STENT RINGS, BUT WAS UNABLE TO DEPLOY THE BARE STENT RINGS. THIS CANNOT BE DETERMINED TO BE A DEVICE FAILURE BECAUSE THE GRAY THUMB GRIP MIGHT HAVE BEEN FORCIBLY TWISTED INSTEAD OF PUSHING THE GRIP TOWARD THE HANDLE BODY AS THE GRIP WAS ORIGINALLY STIFF. THE BLACK RELEASE GRIP WAS PULLED BACK OVER THE GRAY THUMB GRIP, BUT AT THAT POINT THE RELEASE GRIP BECAME IMPOSSIBLE TO PULL AND THE BARE STENT RINGS COULD NOT BE DEPLOYED. EVEN THE METAL PARTS SURROUNDING THE OUTER CONTROL TUBE WERE DESTROYED TO CUT THE STIFF GUIDEWIRE USED TO DELIVER THE STENT GRAFT, AND THE GUIDEWIRE WAS EVENTUALLY CUT. THE BARE STENT RINGS WERE DEPLOYED BY PUSHING AND PULLING THE OUTER CONTROL TUBE, ADVANCING THE GUIDEWIRE, AND SHAKING THE ENTER DELIVERY SYSTEM. THE STENT GRAFT COULD BE PLACED IN THE CENTRAL NECK BUT THE LANDING ZONE WAS MORE PERIPHERAL THAN EXPECTED, THEREFORE AN EXCLUDER AORTA EXTENDER (GORE JAPAN, 26 MM × 45 MM) WAS ADDITIONALLY PLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ENDOLEAK. PHYSICIAN'S COMMENT: SINCE THE BARE STENT RINGS WERE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535846 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P190015. One submission often covers many models, so check the product and lot details in each record.

• Z-1689-2023 · May 3, 2023 · Open, Classified
  The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graf