Destino Twist Steerable Guiding Sheath DST0655517Recalls & reported problems
Oscor Inc. · Steerable Guiding Sheath, 6.5F · Class 2
All models of Destino Twist Steerable Guiding Sheath (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672004064), received between Nov 17, 2021 and Nov 17, 2021 — 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
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DOCTOR FLUSHED THE SHEATH AND DILATOR, AND INSERTED THE DILATOR TO THE SHEATH. THEN THE DOCTOR INSERTED THE SHEATH AND DILATOR TO THE BODY OF THE PATIENT. AFTER THE INSERTION OF THE SHEATH AND DILATOR THE DOCTOR REMOVED THE DILATOR FROM THE SHEATH. AT THAT POINT THE DOCTOR RECOGNIZED A LEAKAGE BETWEEN THE HANDLE OF THE SHEATH AND THE SIDEPORT OF THE SHEATH. BLOOD CAME OUT OF THE HANDLE EXACTLY AT THE POINT WHERE THE SIDEPORT IS CONNECTED TO THE HANDLE OF THE STEERABLE SHEATH. THEREFORE THE DOCTOR DECIDED TO REMOVE THE SHEATH FROM THE BODY OF THE PATIENT AND USED A NEW DESTINO TWIST DST0655517 STEERABLE SHEATH AND FINISHED THE PROCEDURE SUCCESSFULLY WITHOUT ANY ISSUES. BECAUSE OF THE LEAKAGE THE DOCTOR RETURNS THE UNIT FOR FURTHER INVESTIGATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828863 ↗
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 · CompletedDestino Twist 14F (also branded as Guidestar 14F)
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
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- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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