Occlutech Delivery Set III 98DS006Recalls & reported problems
Oscor Inc. · OCCLUTECH DELIVERY SET III, 6F 79CM 45° · 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 00885672010188), received between Jul 26, 2024 and Jul 26, 2024 — 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
- No Apparent Adverse Event1
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.
MalfunctionJul 26, 2024Break; Difficult to Advance; No Apparent Adverse Event; Break; Difficult to Advance; No Apparent Adverse Event
PLEASE BE INFORMED THAT TODAY I FACED AN UNPLEASANT SITUATION AT (B)(6) : ASD PATIENT: 9 MONTHS OLD, 6KG ASD MEASURED 9 MM - DEVICE CHOSEN: ASD10 DUE TO TINY PATIENT DIMENSIONS THE DOWNSIZING OF SHEATH WAS SEEN AS A HUGE ADVANTAGE ASD10 PROCEDURE PACK STATED COMPATIBILITY TO 6F ODS III - SHEATH CHOSEN: ODS III 6F FIRST ODS III 6F SHEATH: HARD TO ADVANCE OCCLUDER & FLEXPUSHER CABLE THROUGH LOADER/ SHEATH ASSEMBLY HUB WITH HEMOSTATIC VALVE & SIDE PORT DETACHED FROM SHEATH EXCHANGED TO SECOND ODS III 6F (SAME LOT#): SAME BEHAVIOR NOT ABLE TO ADVANCE OCCLUDER THROUGH SHEATH/ LOADER ASSEMBLY OCCLUDER - GOT STUCK THIRD SHEATH EXCHANGED TO ODS III 7F + ASD10 EXCHANGED DUE TO HIGH FORCES & UNKNOWN DEVICE INTEGRITY - PROCEDURE WAS SUCCESSFULLY COMPLETED DUE TO THE SHEATH EXCHANGES WITH CAREFUL PRODUCT PREPARATION STEPS ACCORDING TO THE IFU THE PROCEDURE WAS DELAYED BY 40 MIN. THANKS TO MY EXCELLENT RELATIONSHIP TO THE ATTENDING PHYSICIAN DR. (B)(6) AND SENIOR CONSULTANT PROF. (B)(6) I WAS ABLE TO DEESCALATE THIS DELICATE SITUATION IN THE CATH LAB. THIS WOULD HAVE BEEN THE LAST CONVINCING CASE BEFORE THE PEDIATRIC DEPARTMENT WOULD HAVE SWITCHED COMPLETELY TO ODS III DUE TO THE DOWNSIZING AR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19837852 ↗
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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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