DELTAFILL DLF100310Recalls & 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 3mm (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 10886704077039), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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 Frayed1
- 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.
MalfunctionAug 27, 2018Material Frayed; Stretched; Material Frayed; Stretched
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A MODERATELY TORTUOUS VESSEL, THE PHYSICIAN STARTED TO DEPLOY THE 3MM X 10CM DELTAFILL10 (DLF100310/S11155) THERMO-MECHANICAL COIL WHEN HE NOTICED THAT IT WAS FRAYED. THE COIL WAS REMOVED FROM THE SL-10 (STRYKER) MICROCATHETER. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. NO ADDITIONAL INTERVENTION WAS REQUIRED TO PREVENT IMPAIRMENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7818462 ↗
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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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