Destino Twist Steerable Guiding Sheath DST0855517Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672006525), received between Dec 6, 2022 and Sep 4, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• InjurySep 4, 2024Mechanical Jam; No Apparent Adverse Event; Mechanical Jam; No Apparent Adverse Event

  DURING THE PROCEDURE ENDO LEAK POSITION SEARCH AND RENAL STENT PROLONGATION, THE PHYSICIAN HAD TO USE AN 8.5F DESTINO TWIST. HE INSERTED THE SHEATH AND ONCE ON THE CORRECT POSITION, WANTED TO BEND THE CURVE OF THE DESTINO. AS SOON AS HE DID THIS, THE DEVICE SCRATCHED AND WAS NOT USABLE ANYMORE (MEANING THE CURVE HAS NOT BEEN POSSIBLE TO DO). THE PHYSICIAN DECIDED THEN TO TAKE ANOTHER DEVICE IN 8.5F BUT THE SAME PROBLEM HAPPENED. NO HARM TO THE PATIENT. TWO DEVICES WERE USED FOR THAT PROCEDURE TO BE DONE, INSTEAD OF THAT, NO ADVERSE EVENT. DEVICE TO BE RETURNED TO OSCOR. 07/12/2024: CUSTOMER REPORTED A DELAY IN THE PROCEDURE, ANOTHER SHEATH HAS BEEN TAKEN WHICH BROKE AS WELL. THE PHYSICIAN WENT NERVOUS, AND THEY HAD TO FIGURE OUT ANOTHER SOLUTION TO DO THE PROCEDURE. THE PHYSICIAN ACCESSED THE FEMORAL ARTERY WITH FIRST A SHORT 7F SHEATH AND THEN DIRECTLY THROUGH THE SKIN WENT WITH THE DESTINO. SECOND LOT NUMBER REPORTED FOR DP-21586 WILL BE PROCESSED UNDER (B)(4). SUBMITTED FOR ADMINISTRATIVE PURPOSES: 07/29/2024: RECEIVED CONFIRMATION THAT A DELAY OF MORE THAN 30 MINUTES IN TOTAL IS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134405 ↗
• MalfunctionDec 6, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE DESTINO TWIST WAS BENT PROXIMAL TO THE CURVE AND THE DOCTORS COULD NOT GET THE DEVICES THROUGH THE INTRODUCER (SHEATH); IN THE BEGINNING OF THE PROCEDURE THE DOCTORS HAD NOT NOTICED THE DESTINO TWIST WAS BENT. THEY DECIDED TO SWITCH TO AN APTUS 7F, THIS WORKED, BUT NOT FOR ALL REQUIREMENTS. THEY THEN TRIED USING THE DESTINO TWIST AGAIN, BUT AGAIN, THEY WERE NOT ABLE TO GET THE DEVICES THROUGH THE LUMEN (SHEATH) DUE TO THE KINK BEFORE THE CURVE. THEY DECIDED TO USE A NEW DESTINO TWIST (SAME MODEL AND LOT NUMBER) AND IT WORKED. IT WAS REPORTED THERE WAS MORE THAN A 30 MINUTE DELAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925579 ↗

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)