Destino Twist Steerable Guiding Sheath DST0856517Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672006549), received between Oct 10, 2023 and Feb 10, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE CORRECT APPLICATION, THE HEMOSTASIS VALVE IS LEAKING AT THE SIDE OF THE HOUSING. THE PATIENT IS FINE. THERE WAS NO DANGER TO THE PATIENT AT ANY TIME. THERE WAS ONLY A DELAY IN THE OPERATION OF APPROX. 10 MINUTES DUE TO THE EXCHANGE FOR A CORRECT DESTINO TWIST. THE REPLACEMENT PRODUCT WAS THE IDENTICAL DESTINO TWIST SHEATH. THE OPERATION WAS PERFORMED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682652 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING A FENESTRATED ENDOVASCULAR AORTIC REPAIR PROCEDURE AT THE FIRST ANGULATION OF THE SHEATH AT THE LEVEL OF THE TRUNCUS COELIACUS, THE PHYSICIAN STATED THAT THE SHEATH KINKED, AND IT WAS NO LONGER POSSIBLE FOR HIM TO PASS WITH THE WIRE. HE FINISHED THE PROCEDURE SUCCESSFULLY WITH INCREASED EFFORT WITHOUT A STEERABLE SHEATH. THE CUSTOMER REPORTED APPROX. 30-MINUTE DELAY IN THE PROCEDURE. SUBMITTED FOR ADMINISTRATIVE PURPOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908272 ↗

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)