Destino Twist Steerable Guiding Sheath DST0654509Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885672004002), received between May 20, 2021 and Jun 12, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE STROKE (GREEN) ON THE SIDE WAS LEAKING. THE GREEN HUB FROM THE HEMOSTASIS VALVE WAS LEAKING ON THE SIDE. THE PATIENT IS WELL. THE INTERVENTION WAS DONE WITH ANOTHER DESTINO TWIST. THE PROCEDURE WAS AN ENDOLEAK EMBOLIZATION WHICH WAS THE INTERVENTION. THE PATIENT WAS NOT AT RISK. HE IS DOING WELL AND NO FURTHER INTERVENTION WAS NECESSARY. THE TIME DELAY FOR THIS PROBLEM WAS APPROX. 15 - 20 MINUTES. THE CASE WAS REPORTED TO THE SWISS AUTHORITY SWISSMEDICS. DEVICE WILL BE RETURNED TO OSCOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193654 ↗
• MalfunctionMar 5, 2024Break; Break

  THE CUSTOMER REPORTED THAT WHEN THE SCRUB NURSE RECEIVED THE DESTINO TWIST SHEATH ON HER TABLE, THE LATERAL CANNULA FELL DOWN FROM THE HANDLE OF THE SHEATH. IT SEEMS THE CANNULA WAS NOT CONNECTED TO THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837831 ↗
• MalfunctionSep 7, 2021Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

  IT WAS REPORTED THAT DURING A EMBOLISATION, COIL PROCEDURE THE GREEN HUB DISCONNECTED DURING THE PROCEDURE, DURING THE TRANSITION AT THE HANDLING FROM WHITE TO GRAY, BLOOD PRESSED OUT DURING THE ENTIRE PROCEDURE. THERE WAS NO RISK TO THE PATIENT, THEREFORE, THE PROCEDURE WAS FINISHED WITH ANOTHER DESTINO TWIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434398 ↗
• MalfunctionMay 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE A GREEN PIECE OF DESTINO TWIST CAME LOOSE. AN IMAGE PROVIDED BY THE CUSTOMER SHOWS THE HEMOSTATIC VALVE DISLODGED FROM THE HANDLE ASSEMBLY. NO PATIENT HARM REPORTED. ULTRASOUND-GUIDED ACCESS OF THE RIGHT COMMON FEMORAL ARTERY WAS PERFORMED USING A 21-GAUGE MICROPUNCTURE SET. THIS WAS TRANSITIONED OVER A WHOLEY WIRE TO A 6 FRENCH SHEATH AND THEN ULTIMATELY TO A 6.5 FRENCH OSCOR TWIST CONFORMABLE SHEATH WHICH WAS ADVANCED INTO THE ABDOMINAL AORTA UNDER FLUOROSCOPIC GUIDANCE. THE PATIENT WAS SYSTEMICALLY HEPARINIZED. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855014 ↗

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)