Destino Twist Steerable Guiding Sheath DST0705517Recalls & reported problems
Oscor Inc. · Steerable Guiding Sheath, 7F · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672004163), received between Nov 20, 2020 and Nov 20, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
Device problems
- Deformation Due to Compressive Stress2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT (2) OSCOR SHEATHS KINKED AND TWISTED WITHIN THE PATIENT'S BODY RENDERING THEM USELESS, AND REQUIRING THE TEAM TO LOSE ACCESS, AND BEGIN THE PROCEDURE AGAIN. THERE WAS NO PATIENT COMPLICATION REPORTED. FOR SECOND LOT SEE MDR 1035166-2020-00072.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10879488 ↗MalfunctionNov 20, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT (2) OSCOR SHEATHS KINKED AND TWISTED WITHIN THE PATIENT'S BODY RENDERING THEM USELESS AND REQUIRING THE TEAM TO LOSE ACCESS AND BEGIN THE PROCEDURE AGAIN. THERE WAS NO PATIENT COMPLICATION REPORTED. FOR SECOND LOT SEE MDR 1035166-2020-00078.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10878101 ↗
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
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- 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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