Destino Twist Steerable Guiding Sheath DST0706509Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672004187), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 malfunction.

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

• MalfunctionApr 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ACCORDING TO DR. (B)(6), THE INTRODUCER WAS PUSHED INTO THE AORTA VIA A 0.035 GUIDEWIRE, PROBABLY A LUNDERQUIST. THEN INJECTED VIA A CONTRAST MEDIUM PUMP WITH APPROX.1000 DPI CONTRAST. AT THIS PRESSURE, THE HUB DETACHED FROM THE CASING. THERE WAS A VERY LARGE LOSS OF BLOOD. THE WIRE AND THE SHEATH HAD TO BE REMOVED TOGETHER. THEY FINISHED THE INTERVENTION WITH A NEW SHEATH. THERE WERE NO COMPLICATIONS, BUT THE PROCEDURE WAS DELAYED OVER 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171700 ↗

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)