Occlutech Delivery Set III 98DL010Recalls & reported problems
Oscor Inc. · OCCLUTECH DELIVERY SET III, 10F 110CM 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672010324), received between Nov 21, 2024 and Nov 21, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUMMARY: DEVICE DISLOCATION / EMBOLIZATION. THE EVENT OCCURRED DURING PATIENT CONTACT. CONSEQUENCES OF EVENT: PERCUTANEOUS REMOVAL (MEANS REMOVAL OF KIDNEY STONES). EVENT NOTIFIED TO AUTHORITY. [DESCRIPTION / SEQUENCE OF EVENTS]: PERIVALVULAR REGURGITATION CLOSURE PROCEDURES WERE UNDERTAKEN. A PLD WAS IMPLANTED VIA THE TF APPROACH AND AN ODSIII WAS INSERTED TO IMPLANT A SECOND PLD WHEN THE INITIALLY IMPLANTED PLD BECAME DISLODGED. THE PLD WAS LOCATED IN THE LEFT ATRIUM AND RETRIEVED WITH A SNARE CATHETER. AN ATTEMPT WAS MADE TO RESUME THE PLD IMPLANTATION PROCEDURE, BUT THE PATIENT'S BLOOD PRESSURE DROPPED, AND THE PROCEDURE WAS ABANDONED AND TERMINATED. PATIENT CONDITION RESOLVED. THE DEVICE WAS DISCARDED BY THE HOSPITAL. (B)(6) 2024: TF IS TRANSFEMORAL (TF) AND PLD IS OUR OCCLUTECH PARAVALVULAR LEAK DEVICE. AGAIN, MAY I PLEASE CLARIFY THE REPORTED 98DL010; LOT: DP-21333 IS NOT A COMPLAINT AND HAS NOT BEEN GIVEN ANY COMPLAINT NUMBER FROM US AS WELL. (B)(4) IS ASSIGNED TO THE OCCLUTECH PARAVALVULAR LEAK DEVICE ONLY. PLEASE PROVIDE US ONLY THE BATCH RECORD REVIEW FOR THE MENTIONED ODS III ONLY SINCE THE CUSTOMER CLAIMED FOR ONE. [NOTE]: ALL MEDICAL RECORDS, INCLUDING CTS, ARE NOT AV
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 20745489 ↗
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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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