Thoraflex™ Hybrid THA2830X100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881026923), received between Jun 6, 2025 and Jun 17, 2025 — classified as 1 death, 2 injuries.

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

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

• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EVENT NAME: POST-OPERATIVE ANAEMIA. EXTEND-001 STUDY (B)(4), PATIENT: (B)(6), POST OPERATIVE DAY 1 (ON (B)(6) 2025), HAD A LOW BLOOD COUNT. PATIENT OUTCOME: THE SITE HAVE INDICATED THAT NO ACTION WAS TAKEN TO TREAT THE ADVERSE EVENT BUT THAT THE TYPE OF RECOVERY WAS RESOLVED WITH TREATMENT. THE EVENT WAS CONSIDERED RESOLVED ON POST-OP DAY 11 (ON (B)(6) 2025). THE EVENT WAS MODERATE IN SEVERITY.

  Patient problems: Anemia

  MAUDE report 22233562 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EVENT REPORTED BY CLINICAL TRIAL : EXTEND - (B)(6). ON POST OPERATIVE DAY 1 ((B)(6) 2025), AN ADVERSE EVENT (AE) OF THROMBOCYTOPENIA WAS REPORTED BY SITE FOR SUBJECT (B)(6) - FURTHER COMMENTS DETAIL "LOW PLATELET COUNT". OUTCOME OF THE AE IS ONGOING AT TIME OF REPORTING, WITH STATUS OF UNRESOLVED NOT TREATING. CONCOMITANT MEDICATIONS ARE NOT LISTED AT TIME OF REPORTING, SITE WILL BE REQUESTED TO COMPLETE AS SOON AS POSSIBLE. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP 1 FOR MANUFACTURING REPORT NUMBER TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0254.

  Patient problems: Thrombocytopenia

  MAUDE report 22174010 ↗
• DeathJun 6, 2025Fluid/Blood Leak; Device Stenosis; Fluid/Blood Leak; Device Stenosis

  EVENT DATE: 13 MAY 2025. IMPLANT DATE: (B)(6) 2025. EVENT REPORTED FROM (B)(6). THORAFLEX ANTE-FLOW DEVICE IMPLANTED IN A 51-YEAR-OLD MALE PATIENT WITH CHRONIC TYPE A AORTIC DISSECTION (CTAD) AND CAD W/ BYPASS AT TIME OF ARCH REPAIR. AFTER THE PROCEDURE THE DEVICE APPEARED NARROW USING TEE (UNDERSTOOD TO BE TRANSOPHAGEAL ECHOCARDIOGRAM) AT THE ANASTOMOSIS OF THE THORAFLEX COLLAR. IVUS (UNDERSTOOD TO BE INTRAVASCULAR ULTRASOUND) WAS USED AND AN AORTIC BALLOON WAS INSERTED THROUGH THE PERFUSION ARM OF THE THORAFLEX DEVICE, THE NARROWING WAS BALLOONED AND UNDER IVUS VISUALIZATION IT WAS EXPANDED. HOWEVER, IT DID NOT STAY OPEN. THE SURGEON DECIDED TO BEGIN CLOSING AND WOULD PLAN ON COMING BACK AND EXPANDING WITH A BX (UNDERSTOOD TO BE BALLOON- EXPANDABLE) STENT. HOWEVER, THE PATIENT WAS BLEEDING FROM AN INDETERMINATE SOURCE AND THEY REMAINED IN THE ROOM TRYING TO IDENTIFY THE LOCATION. THEY DECIDED TO STOP AND TRANSPORT THE PATIENT TO RECOVER WHERE HE PASSED. IT'S UNCERTAIN IF THE NARROWING WAS A TECHNICAL OR DEVICE RELATED COMPLICATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stenosis

  MAUDE report 22156764 ↗