Destino Twist Steerable Guiding Sheath DST0654509TDRecalls & 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
- 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 00885672004101), received between Jan 9, 2017 and Jun 2, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT VALVE OF DESTINO TWIST DETACHED FROM THE HOUSING WITHOUT ANY POWER. PHYSICIAN WANT TO START STENTING BUT WITHOUT HEMOSTATIC VALVE IT WAS IMPOSSIBLE. PHYSICIAN USED DIFFERENT DESTINO TWIST TO CONTINUE THE PROCEDURE. THERE WAS NO BLOOD LOSS OR ADVERSE PATIENT SIDE EFFECTS REPORTED. THERE WAS NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11924397 ↗MalfunctionJan 9, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
DURING A PROCEDURE 5-6CM STRING OF PLASTIC CAME OUT OF THE TWIST AFTER REMOVING CATHETER. PATIENT WAS NOT INJURED DURING PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6234438 ↗
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)
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- 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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