Tissue Helix M00505460Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506060053), received between Sep 4, 2026 and Sep 4, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 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.

• InjurySep 4, 2026Difficult to Remove

  It was reported to Boston Scientific Corporation that a Tissue Helix was used during a procedure on (b)(6)2026.During the procedure, the helix had difficultly removing from the patients tissue about 5 to 7 times, taking an extra 1 to 2 minutes to untwist from the tissue. As a result, the physician used a new helix and continued the procedure. The second helix was also difficult to remove from the patient's tissue. The procedure was completed with the second helix. It is reported that as a result of this event, the patient experienced discomfort and pain, Physician believes that the patient has a perforation, medical intervention was deemed necessary but uncertain what was done.No further information has been obtained despite good faith effort.This is the second of two Tissue Helixes used in the same procedure.

  Patient problems: Discomfort; Pain; Perforation

  MAUDE report 50612702 ↗
• InjurySep 4, 2026Difficult to Remove

  It was reported to Boston Scientific Corporation that a Tissue Helix was used during a procedure on (b)(6) 2026.During the procedure, the helix had difficultly removing from the patients tissue about 5 to 7 times, taking an extra 1 to 2 minutes to untwist from the tissue. As a result, the physician used a new helix and continued the procedure. The second helix was also difficult to remove from the patient's tissue. The procedure was completed with the second helix. It is reported that as a result of this event, the patient experienced discomfort and pain, Physician believes that the patient has a perforation, medical intervention was deemed necessary but uncertain what was done.No further information has been obtained despite good faith effort.This is the second of two Tissue Helixes used in the same procedure.

  Patient problems: Discomfort; Pain; Perforation

  MAUDE report 50612700 ↗