TREO Abdominal Stent-Graft System 28-B2-33-120URecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843576152540), received between Oct 17, 2024 and Jun 23, 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.

• MalfunctionJun 23, 2026Difficult or Delayed Separation

  "DURING THE CLASP RELEASE STAGE OF THE PROCEDURE THE DISTAL CLASP MOVED PROXIMALLY RATHER THAN THE PROXIMAL CLASP RETRACTING DISTALLY TO RELEASE THE SUPRARENAL FIXATION. SOME DIFFICULTY WAS OBSERVED REMOVING THE DELIVERY SYSTEM FROM THE PATIENT. WE FEEL THAT IT WAS DUE TO THE PRESSURE OF THE AORTA PUSHING DOWN ON THE DELIVERY SYSTEM AND STENT GRAFT. THE PATIENT ANATOMY APPEARED TORTUOUS WITH BENDING POSTERIORLY. GOOD PATIENT OUTCOME." PATIENT OUTCOME; "NO PATIENT INJURY OR ADVERSE OUTCOMES ASSOCIATED WITH THIS CASE. FOLLOW-UP WITH PHYSICIAN MONDAY 06/01/2026 WAS POSITIVE AND PATIENT WAS SENT HOME ON TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600210 ↗
• MalfunctionMar 23, 2026Mechanical Jam

  "AFTER DEPLOYMENT OF CONTRALATERAL GATE, THE PROXIMAL CLASP WAS ATTEMPTED TO BE RELEASED. WHILE TRYING TO MANIPULATE THE GRAY LOCK, IT WOULD NOT MOVE IN ANY FASHION. MULTIPLE ATTEMPTS WERE MADE TO UNLOCK THE PROXIMAL CLASP. WITH THE GRAY LOCK UNABLE TO BE SUCCESSFULLY TURNED, THE WINGS OF THE BLACK RELEASE GRIP WERE BENT AND BROKEN OFF OF THE DEVICE TO MAKE IT AS FLUSH AS POSSIBLE. AFTER THIS WAS DONE, THE RELEASE GRIP WAS RETRACTED AND PROXIMAL CLASP RELEASED SUCCESSFULLY." PATIENT OUTCOME: "THERE WAS NO PATIENT INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669503 ↗
• MalfunctionMay 21, 2025Device Damaged Prior to Use; No Apparent Adverse Event; Device Damaged Prior to Use; No Apparent Adverse Event

  "THE GRAFT WAS OPENED AT IT WAS NOTED THAT THE TIP OF THE CATHETER WAS BENT WHERE THE MAIN TUBE OF THE GRAFT WOULD HAVE BEEN. THE PHYSICIAN DIDN'T FEEL THAT WOULD BE SAFE TO IMPLANT IN THE BODY. WE OPENED A SECOND GRAFT AND PROCEEDED WITH THE CASE SUCCESSFULLY." PATIENT OUTCOME: "THE GRAFT WAS NOT IMPLANTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061471 ↗
• InjuryMar 19, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "I WAS NOTIFIED THAT MS. (B)(6) CAME IN ON (B)(6) 2025 EARLY IN THE MORNING WITH A RUPTURED ILIAC LIMB. UPON OPENING THE PATIENT, THE DOCTORS WERE ABLE TO CONTROL THE BLEEDING AND REPLACED THE STENT GRAFT LIMBS WITH DACRON GRAFTS. IT WAS NOTED THAT IT LOOKED TO BE THAT THE CA+ HAD ERODED INTO THE STENT GRAFT LIMBS THUS CAUSING THE LEAK. PATIENT SEEMS TO BE DOING FINE." PATIENT OUTCOME: "SHE SEEMS TO BE DOING FINE."

  Patient problems: Clinical Endoleak

  MAUDE report 21646128 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  "SUBJECT: (B)(6) HAD THEIR 2-YEAR FOLLOW-UP ON (B)(6) 2024 WITH A CT DATED ON (B)(6) 2024 WHICH SHOWED A TINY EXTRAVASATION AT POSTERIOR ASPECT OF LEFT ILIAC LIMB FOR POSSIBLE ENDOLEAK (CONFIRMED AS TYPE IA ENDOLEAK BY THE INVESTIGATOR), RIGHT COMMON ILIAC ARTERY (CIA) DISSECTION AND 100MM X 94MM ANEURYSM. ON (B)(6) 2024, THE INVESTIGATOR MET WITH THE SUBJECT AGAIN TO FURTHER DISCUSS TREATMENT OPTIONS. HE STATED A FEVAR WITH PMEG WOULD BE MOST APPROPRIATE AS THE LONG TERUMO MAIN BODY WOULD ALLOW PMEG PLACEMENT MORE READILY THAN A STANDARD EVAR. AN ADDITIONAL CT DATED ON (B)(6) 2024 NOTED THE ANEURYSM WAS 'ESSENTIALLY UNCHANGED MEASURING 98MM', THE PREVIOUSLY DESCRIBED ENDOLEAK WAS LESS CONSPICUOUS, AND THE RIGHT CIA DISSECTION WAS ALSO UNCHANGED. ON (B)(6) 2024, THE SUBJECT UNDERWENT A FEVAR USING A PMEG DEVICE AND COIL EMBOLIZATION ON THE RIGHT INTERNAL ILIAC ARTERY. THE PMEG WAS IMPLANTED IN THE SMA AND BILATERAL RENAL ARTERIES ON A BIFURCATED MODULAR PLATFORM WITH 4 FENESTRATIONS AND 3 BRIDGING STENTS. THE COIL EMBOLIZATION WAS PERFORMED USING A 10MM POD DEVICE. THE SUBJECT WAS ADMITTED SAME-DAY FOR OBSERVATION." PATIENT OUTCOME: "THE EVENT WAS CONSIDERED AS RESOLVED AT TIME OF

  Patient problems: Clinical Endoleak; Vascular Dissection

  MAUDE report 20475458 ↗

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