Thoraflex™ Hybrid THP2628X150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881026800), received between May 5, 2025 and Jan 26, 2026 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJan 26, 2026Partial Blockage; Fluid/Blood Leak

  EVENT REPORTED FROM CLINICAL STUDY AS ACUTE MESENTERIC ISCHEMIA (AMI) CLINICAL TRIAL (B)(4), ON POST OPERATIVE DAY 12 ((B)(6) 2025), PATIENT (B)(6) WAS NOTED TO HAVE INCREASED ABDOMINAL DISTENSION, COLONIC DILATATION, AND INCREASED PRESSOR REQUIREMENTS. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2025 FOR CONCERN OF BOWEL ISCHEMIA. CRITICAL FINDINGS OF RETROPERITONEAL HEMATOMA AND SMA (SUPERIOR MESENTERIC ARTERY) OCCLUSION. ON (B)(6) 2025 THE PATIENT HAD AN EXPLORATORY LAPAROTOMY; VASCULAR SURGERY WAS CONSULTED FOR SMA EMBOLECTOMY. DURING THE OPERATION CHRONIC APPEARING THROMBUS WAS RETRIEVED FROM THE DISTAL SMA WITH A SMALL AMOUNT OF THROMBUS EMANATING INTO ONE OF THE BRANCHES. A THROMBECTOMY WAS PERFORMED ON EACH OF THE 5 PRIMARY BRANCHES THAT HAD BEEN ISOLATED. A SMALL AMOUNT OF THROMBUS WAS RETRIEVED FROM ONLY ONE OF THE BRANCHES, THE REMAINDER OF THE BRANCHES HAD ALL BACK BLEEDING AND NO THROMBUS. THE INVESTIGATOR CONSIDERED THE EVENT OF ACUTE MESENTERIC ISCHEMIA AS SERIOUS, WITH SEVERE SEVERITY AND NOT RELATED TO THE DEVICE, THERE WAS NO DEVICE DEFICIENCY DURING OR AFTER THE PROCEDURE. HOWEVER, THE CLINICAL EVENTS COMMITTEE (CEC) ON ADJUDICATION HAVE DOCUMENTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 24176122 ↗
• InjuryMay 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT REPORTED FROM EXTEND STUDY - (B)(6) (SITE (B)(4) FOR PATIENT (B)(6) EVENT WAS INITIALLY COMMUNICATED WITH NO DEVICE DETAILS ON 03 APR 25, DEVICE DETAILS PROVIDED ON 07 APR 25. EVENT OF RIGHT UPPER EXTREMITY AND RIGHT LOWER EXTREMITY WEAKNESS EVENT DATE (B)(6) 2025 FOLLOWED BY LEFT ARM WEAKNESS EVENT DATE (B)(6) 2025 AND ALSO EVENT OF MODERATE ACUTE MICROVASCULAR ISCHEMIC INFARCTS EVENT DATE (B)(6) 2025. THERE WAS NO DEVICE FAILURE/DEFICIENCY REPORTED. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP # 2 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00041 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).

  Patient problems: Neuropathy; Stroke/CVA

  MAUDE report 21959729 ↗