GORE TAG Thoracic Branch Endoprosthesis TSB122006ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132654420), received between Aug 18, 2023 and Apr 10, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 19, 2026Class IIOpen, Classified

   Due to catheter separation

   Z-2672-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionApr 10, 2026Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device Damaged by Another Device

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION IN ZONE 0 OF THE ASCENDING AORTA AND AORTIC ARCH UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TAC123715 AND TSB122006). REPORTEDLY, THERE WAS DIFFICULTY ADVANCING THE SIDE BRANCH COMPONENT THROUGH THE AORTIC COMPONENT PORTAL, BUT THE PHYSICIAN WAS ABLE TO ADVANCE THE SIDE BRANCH COMPONENT SUCCESSFULLY TO THE INTENDED LOCATION. THE SIDE BRANCH COMPONENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, THE LEADING OLIVE TIP GOT STUCK ON THE PROXIMAL END OF A BALLOON CATHETER COMING IN FROM THE OPPOSITE DIRECTION OF THE INNOMINATE ARTERY. AS THE PHYSICIAN BEGAN TO REMOVE THE SIDE BRANCH COMPONENT DELIVERY CATHETER, THE LEADING OLIVE BROKE OFF AND WAS STUCK ON THE GUIDEWIRE. THE PHYSICIAN WAS ABLE TO GET THE BROKEN OLIVE TIP INTO THE SHEATH AND USE A SNARE TO REMOVE IT. THERE WERE NO PATIENT ADVERSE EVENTS REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845452 ↗
• MalfunctionMar 24, 2026Break

  ON (B)(6) 2026, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION, UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT + 2 SIDE BRANCH COMPONENTS). ALLEGEDLY, THE PHYSICIAN IMPLANTED THE TBE AORTIC COMPONENT INTO THE AORTIC ARCH WITH THE PORTAL LEANING MORE ANTERIOR. THE PHYSICIAN DECIDED TO LEAVE IT AS IS, TO KEEP THE STROKE RISK LOW. UPON TRYING TO DEPLOY THE FIRST SIDE BRANCH COMPONENT (SERIAL# (B)(6), THE DEVICE WOULD NOT ADVANCE SMOOTHLY THROUGH THE PORTAL, AND MULTIPLE TECHNIQUES WERE ATTEMPTED WITHOUT SUCCESS. THE PHYSICIAN THEN BALLOONED THE PORTAL USING A 7 MM × 4 CM PTA BALLOON, AFTER WHICH THE SIDE BRANCH COMPONENT ADVANCED AND DEPLOYED SUCCESSFULLY. IT WAS ALSO REPORTED, DUE TO THE PORTAL BEING ROTATED ANTERIORLY, THE DECISION WAS MADE TO ADD A SECOND TBE SIDE BRANCH (SAME SIZE, SERIAL# (B)(6) TO EXTEND FURTHER INTO THE INNOMINATE ARTERY. THE DEVICE WAS DELIVERED EASILY WITH MINIMAL RESISTANCE GOING THROUGH THE EXISTING TBE SIDE BRANCH DEVICE. THE DELIVERY CATHETER WAS REMOVED EASILY. ALLEGEDLY, UPON WITHDRAWING THE SECOND DELIVERY CATHETER OF THE SIDE BRANCH COMPONENT (SERIAL#(B)(6) THROUGH THE DRYSEAL SHEATH, THE PHYSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674061 ↗
• MalfunctionAug 18, 2023Detachment of Device or Device Component; Wrong Label; Detachment of Device or Device Component; Wrong Label

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A PSEUDOANEURYSM. THE PHYSICIAN INSERTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. DURING PLACEMENT, THE SIDE BRANCH PORTAL ENDED UP ON INNER CURVE OF THE AORTA, RATHER THAN THE PREFERRED LOCATION ON THE OUTER CURVE. THE SHEATH FROM THE INNOMINATE WAS PAST THE OSTIUM BUT ABOVE THE GRAFT. THE SECOND SIDE BRANCH DEPLOYED AND THE OLIVE TIP BROKE OFF, TAKING THE CURVE OF THE FIRST SIDE BRANCH. IT WAS REMOVED WITH NO HARM TO THE PATIENT. IT WAS NOTED THAT A SOFT GLIDE WIRE WAS USED INSTEAD OF A STIFF WIRE, AS THE SCRUB TECH HANDED UP THE WRONG WIRE. THE SURGICAL TEAM DIDN'T WANT TO DO A WIRE EXCHANGE, SO DECIDED TO TRY AND MAKE IT STIFF BY PULLING ON BOTH ENDS. THE PHYSICIAN IS UNSURE IF USING THE SOFT GLIDE WIRE CONTRIBUTED TO THE EVENT, BUT THAT HE WOULD USE A STIFF WIRE IN THE FUTURE. IT WAS ALSO NOTED THAT THE SERIAL NUMBER ON THE BOX AND PACKAGE DID NOT MATCH THE SERIAL NUMBER ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574539 ↗