Destino Reach Steerable Guiding Sheath DCR0856717Recalls & reported problems
Oscor Inc. · Steerable Guiding Sheath, 8.5F · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672007553), received between Jul 28, 2026 and Jul 28, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Fluid/Blood Leak
The valve of the sheath was leaking from the beginning and allowed blood leakage, despite a 0.035" Terumo guidewire being in place. Consequently, the position had to be abandoned, and the sheath was replaced with a new Destino Reach. Device valve leakage / blood leakage; patient experienced blood loss. Issue was Identified during mid BEVAR procedure, during cannulation of the target vessel. Terumo 0.035" guidewire used in combination with the Oscor product. The sheath was removed and replaced with another Destino Reach. There was an approximate 10-minute procedural delay. No patient harm reported, and no extended hospitalization reported.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50053249 ↗
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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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