Destino Twist Steerable Guiding Sheath DST1209030Recalls & reported problems
Oscor Inc. · Steerable Guiding Sheath, 12F · 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 00885672006877), received between Mar 11, 2020 and Aug 17, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Deformation Due to Compressive Stress1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279507 ↗MalfunctionMar 11, 2020Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE THE PULL WIRES INSIDE THE TWIST HAVE RIPPED SO THE SHEATH WAS NOT STEERABLE ANYMORE. THE DOCTOR USED THE DESTINO TWIST 12F SHEATH FOR A PVL (PARAVALVULAR LEAKAGE) AND A SYSTEM OF OCCLUTECH (PVL - OCCLUDER). AFTER HE FIXED THE CURVE IN A PREFERRED POSITION, HE REALIZED THAT THE STEERABILITY OBVIOUSLY EASED UP. IN THIS MOMENT THE SHEATH'S TIP WAS ABOUT TO STRAIGHTEN UP BACK IN THE INITIAL STATE AND THE CURVE DIDN'T HOLD AS EXPECTED. THE DOCTOR HAD REACTED DIRECTLY AND PULLED THE SHEATH OUT, THERE WAS A 10 MINUTE DELAY. HE COMPLETED THE PROCEDURE SUCCESSFULLY BY USING ANOTHER DESTINO TWIST SHEATH (SAME LOT NUMBER). THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9818988 ↗
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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