Destino Steerable Guiding Sheath DS127122Recalls & reported problems
Oscor Inc. · Steerable Guiding Sheath, 12F · Class 2
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 00885672000462), received between Sep 2, 2020 and Sep 2, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
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
- Defective Device1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2020Defective Device; Defective Device
IT WAS REPORTED THE DEVICE WAS INTACT BUT THE DILATOR WAS VISIBLY SHORTER THAN THE CATHETER SHAFT. SEVERAL TRIALS WERE MADE ON DESK BUT THE DEVICE RESULTED UNUSABLE.
Patient problems: No Information
MAUDE report 10484751 ↗
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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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