Destino Twist Steerable Guiding Sheath DST1387139Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672005597), received between Nov 8, 2019 and Nov 8, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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.

• InjuryNov 8, 2019Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT HAPPENED ABOUT 2 MIN AFTER REMOVAL OF THE DILATOR DURING PREPARATION OF THE AFREEZE COOLLOOP CATHETER FOR INTRODUCTION INTO THE SHEATH. THE COOLLOOP CATHETER HAS NEVER BEEN IN CONTACT WITH THE SHEATH. NO OTHER CATHETER PRODUCT WAS USED AT ANY TIME BEFORE THE EVENT HAPPENED. IT WAS REPORTED THAT THE SHEATH WAS CONNECTED TO THE SMARTABLATE SYSTEM IRRIGATION PUMP OF BIOSENSE WEBSTER FOR FLUSHING. FOR INTRODUCTION AND REMOVAL OF DILATOR AND TRANSSEPTAL NEEDLE THE FLOW RATE WAS INCREASED TO THE MAXIMUM.

  Patient problems: Cardiac Arrest; ST Segment Elevation

  MAUDE report 9297149 ↗

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)