D'VILL™ 612845Recalls & reported problems
B Braun Interventional Systems, Inc · DV1485 DVill Intro 14F 85cm 0.035GW · Class 2
Data updated Oct 16, 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 04046955128297), received between Aug 23, 2023 and Aug 23, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2023Material Fragmentation; Material Fragmentation
AS REPORTED TO NUMED BY THE DISTRIBUTOR / END USER - BACK END OF THE DILATOR HAD BROKEN OFF. UPON REMOVAL FROM THE BODY THEY FOUND THAT THE DISTAL TIP OF THE DILATOR WAS NO LONGER ATTACHED TO THE MAIN BODY OF THE DILATOR. THE DISTAL TIP OF THE DILATOR WAS SITTING IN THE L MAIN PULMONARY ARTERY STILL ON THE WIRE. THEY SPENT SEVERAL HOURS TRYING TO GET IT OUT UNSUCCESSFULLY. THE SNARE USED, CUT THROUGH THE DILATOR TIP AND BROKE IT INTO TWO MORE PIECES. THEY ENDED UP HAVING TO TRAP ONE PIECE UNDER A STENT IN THE ILIAC AND THE OTHER EMBOLIZED INTO A SMALL SUBSEGMENTAL PULMONARY ARTERY BRANCH, WHICH THEY EVALUATED BY CT AND FELT WAS HIGHER RISK TO REMOVE THAN TO LEAVE IN PLACE ON ANTICOAGULATION.
Patient problems: Foreign Body In Patient
MAUDE report 17603667 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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