GORE Tri-Lobe Balloon Catheter BCM1634Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132605231), received between Jun 3, 2022 and Jan 22, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 0 THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS EXTREMELY TORTUOUS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE POST PROCEDURE. THE PHYSICIAN ALSO NOTED THAT IT MAY HAVE OCCURRED INTRA PROCEDURE. REPORTEDLY THE CAUSE OF THE STROKE IS UNKNOWN, BUT IT WAS SUSPECTED TO BE RELATED TO WIRE AND DEVICE MANIPULATION. DUE TO THE ANATOMICAL TORTUOSITY, THERE WAS ALSO DIFFICULTY REPORTED WHILE ATTEMPTING TO ALIGN THE PORTAL OF THE THORACIC BRANCH AORTIC COMPONENT TO THE OUTER CURVE IN AORTIC ZONE 0. IT WAS REPORTED THAT THE PATIENT REMAINED IN THE HOSPITAL POST PROCEDURE FOR STROKE COMPLICATIONS INCLUDING APHASIA. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT THE PATIENT'S APHASIA WAS SIGNIFICANTLY IMPROVED, AND THE PATIENT WAS WALKING WITH THE PHYSICAL THERAPIST. THE PATIENT WAS REPORTEDLY DISCHARGED TO HOME ON OR ABOUT (B)(6) 2022.

  Patient problems: Stroke/CVA

  MAUDE report 16221811 ↗
• InjuryJun 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), GORE® MOLDING & OCCLUSION BALLOON CATHETERS, AND A GORE® TRI-LOBE BALLOON CATHETER IN THE AAA1701 TAMBE PIVOTAL STUDY. ON (B)(6) 2020 SPINAL CORD ISCHEMIA WAS REPORTED. IT WAS REPORTEDLY NOTED IN THE OP NOTES THAT THE SPINAL CORD ISCHEMIA WAS SUSPECTED TO BE RELATED TO BALLOON MOLDING VERSUS DEVICE MANIPULATION. BILATERAL LOWER EXTREMITY WEAKNESS WAS ALSO REPORTED. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO AN IN-PATIENT REHABILITATION CENTER ABOUT AN HOUR AWAY. THE EVENT IS ONGOING.

  Patient problems: Ischemia; Muscle Weakness/Atrophy

  MAUDE report 14794787 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH SEVERAL GORE® EXCLUDER® AFTERMARKET DEVICES, AS WELL AS THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). DURING THE PROCEDURE THREE DRYSEAL FLEX INTRODUCER SHEATH WERE USED, AS WELL AS A GORE® MOB BALLOON, A GORE® TRI-LOBE BALLOON AND A GORE® TRI LUMEN CATHETER. GORE WAS UNABLE TO DETERMINE WHICH OF THE IMPLANTED DEVICES OR GORE ACCESSORIES WERE INVOLVED IN THE EVENT. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH FEMORAL COMPARTMENT SYNDROME (UNKNOWN IF IT WAS ON THE LEFT OR RIGHT SIDE). THE PHYSICIAN REINTERVENED AND PERFORMED A FASCIOTOMY. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 14597155 ↗