Destino Twist Steerable Guiding Sheath DST1207522Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672006716), received between Feb 19, 2018 and Feb 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K140406); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2018Break; Break

  THE CUSTOMER REPORTED THE INCIDENT OCCURRED DURING A THORACOABDOMINAL AORTIC ANEURYSM OPERATION. THE WIRE FOR DEFLECTION BROKE THROUGH THE COVER OF THE SHEATH. (SEE PICTURES ATTACHED) AFTER IT HAD BEEN NOTICED THAT THERE IS A WIRE POKING THROUGH, THE SHEATH HAD BEEN TAKEN OUT. THE INCIDENT CAUSED NO INJURY NOR COMPLICATION FOR THE PATIENT AND THE OPERATION COULD BE SUCCESSFULLY COMPLETED. THE PROBLEM COULD HAVE ORIGINATED FROM THE BRAIDING WITHIN THE SHEATH. HOWEVER, IT COULD ONLY BE UNDERSTOOD THROUGH EXAMINATION OF THE SHEATH HOW THE WIRE COULD COME OUT OF THE SHEATH AND WHAT EXACTLY CAUSED THIS TO HAPPEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7281197 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140406. One submission often covers many models, so check the product and lot details in each record.

• Z-0646-2022 · Dec 22, 2021 · Completed
  Destino Twist 14F (also branded as Guidestar 14F)