Destino Twist Steerable Guiding Sheath DST0706509TDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672004422), received between Jun 2, 2022 and Jun 2, 2022 — 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.

• MalfunctionJun 2, 2022Break; Break

  IT WAS REPORTED DURING A FENESTRATE AORTIC PROSTHESIS PROCEDURE, BY WAY OF ILIAC ACCESS, THE DESTINO TWIST SHEATH HANDLE DETACHED WHEN IT WAS TURNED (WITHOUT MUCH PRESSURE). THE PHYSICIAN WAS NOT CERTAIN HOW MANY CATHETERS HE HAD ALREADY USED THROUGH THE DESTINO TWIST, HOWEVER, A NEW DESTINO TWIST WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS STABLE. THE PROCEDURE WAS PROLONGED BY 30 MINUTES, AS THE OPERATION WAS VERY COMPLEX. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575397 ↗

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)