Occlutech Delivery Set III 98US006Recalls & reported problems
Oscor Inc. · OCCLUTECH DELIVERY SET III, 6F 79CM 180° · Class 2
All models of Occlutech Delivery Set III (10)
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 00885672010195), received between Aug 8, 2025 and Aug 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Difficult to Advance1
- 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.
MalfunctionAug 8, 2025Break; Fluid/Blood Leak; Difficult to Advance; Break; Fluid/Blood Leak; Difficult to Advance
THE CUSTOMER STATED THAT DURING AN IMPLANT PROCEDURE (PATIENT INVOLVED), THE PHYSICIAN USED AN MVSD 6 MM DEVICE, WHICH SHOULD BE COMPATIBLE WITH THE ODS III 6F DELIVERY SET. THE DEVICE WAS INSPECTED PRIOR TO USE. HOWEVER, UPON REACHING THE CURVED PART OF THE DELIVERY SET, THE CABLE COULD NOT ADVANCE FURTHER. IT LOST PUSHABILITY AND WAS NO LONGER RESPONSIVE, PREVENTING PROPER DEPLOYMENT. AS A RESULT, PHYSICIAN UPSIZED TO AN ODS III 7F (98US007, LOT; DP-21419), AFTER WHICH THE DEVICE WAS SUCCESSFULLY DEPLOYED. THE PATIENT RECOVERED AND EVENT RESOLVED. ADDITIONALLY, A PART OF THE LOADER CAME OUT OF PLACE WHILE ADVANCING THE DEVICE, WHICH RESULTED IN BLOOD SPILLAGE. THE ISSUE IS RELATED TO THE COMPATIBILITY PROBLEM BETWEEN THE MVSD 6 MM AND ODSIII 6F. CLINICALLY SIGNIFICANT EXTENDED TREATMENT OR PROCEDURE TIME. THE AFFECTED ODSIII WAS DISCARDED BY THE HOSPITAL. PLEASE FIND THE PICTURES ATTACHED AS PROVIDED BY CUSTOMER. THERE WAS A DELAY, LESS THAN 30 MINUTES. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE 7F DELIVERY SET. THE PATIENT'S ANATOMY WAS NORMAL, WITH NO ABNORMALITIES OR CHALLENGES NOTED DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751071 ↗
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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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