Destino Reach Steerable Guiding Sheath DCR1007322Recalls & reported problems
Oscor Inc. · Steerable Guiding Sheath, 10F · 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 00885672007638), received between Jun 7, 2023 and Jun 7, 2023 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN OSCOR DESTINO 10F WAS NOT FUNCTIONING PROPERLY. ON (B)(6)2023 ADDITIONAL INFORMATION WAS RECEIVED THAT AN OSCOR SHEATH WAS USED DURING A CASE WITH FENESTRATED EVAR. THE SHEATH HANDLE STARTED LEAKING AFTER THE FIRST FENESTRATION WAS PERFORMED. THE DEVICE WAS USED IN COMBINATION WITH THE ADJUNCT THAT IS NORMALLY USED IN A FEVAR CASE (CATHETERS, WIRES, STENT GRAFTS). THERE WAS A DELAY IN THE PROCEDURE, HOWEVER THE MINUTES ARE UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WHEN ANOTHER PRODUCT WAS OPENED AND USED. THERE IS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17078738 ↗
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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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