Destino Twist Steerable Guiding Sheath DST0655509TDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672004033), received between Feb 4, 2022 and Feb 4, 2022 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2022Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

  IT WAS REPORTED IMMEDIATELY AFTER FIRST CONTRAST INJECTION, THE HUB CAP (GREEN HOUSING) OF THE 6.5F DESTINO TWIST LEAKED, INCLUDING VERY SMALL AMOUNT OF BLOOD. THERE WAS A 5 MINUTE DELAY GETTING A NEW 8.5F DESTINO TWIST HOWEVER, PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13458263 ↗

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)