DELTAFILL DLF100250Recalls & reported problems
Cerenovus, Inc. · DELTAFILL Microcoil 10 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: DELTAFILL 10 Stretch Resistant Coil 2.5mm (coil diameter) x 10cm (coil length) 190cm (working length) · Class 2 · Implant
Data updated Oct 13, 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 10886704076971), received between Nov 27, 2018 and Nov 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Twisted/Bent1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, IT TOOK FOUR ATTEMPTS TO DETACH TO FINALLY GET THE SECOND DELTAFILL 10 COIL TO DETACH USING THE ENPOWER CONTROL CABLE. THE REST OF THE COILS USED IN THE PROCEDURE DETACHED WITHOUT ANY ISSUE. THERE WERE TWO DELTAFILL COILS, THE DELTAFILL 10 3MM X 10CM (DLF100310 / L10337) AND THE DELTAFILL 10 2.5MM X 10CM (DLF100250 / L11537) THAT WERE OPENED BY MISTAKE AND THEY GOT MIXED ON THE TABLE. AS A RESULT, IT WAS NOT KNOWN WHICH OF THESE TWO COILS WERE USED. THERE WAS NO ISSUE WITH THE CONTROL CABLE; THE SAME CABLE WAS USED TO SUCCESSFULLY DETACH THE REST OF THE COILS USED IN THE PROCEDURE. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. ALL THE CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT THE APPLICATION OF EXCESSIVE FORCE. THERE WAS NO ¿SYSTEM FAULT¿ ON THE DETACHMENT CONTROL BOX (DCB). THE DEVICES WERE STORED, HANDLED AND PREPPED PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. THE PROCEDURE WAS REPORTED TO HAVE TAKEN ¿LONGER TIME¿ DUE TO THE FOUR ATTEMPTS TO DETACH THE SECOND DELTAFILL 10 COIL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8108885 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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