DELTAXSFT DLX100406Recalls & reported problems
Cerenovus, Inc. · DELTAXSFT Microcoil 10 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: DELTAXSFT 10 Microcoil 4mm (coil diameter) x 6cm (coil length) 190cm (working length) · Class 2 · Implant
All models of DELTAXSFT (13)
Data updated Oct 16, 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 10886704077367), received between Sep 12, 2024 and Sep 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Advance1
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.
MalfunctionSep 12, 2024Failure to Advance; Failure to Advance
AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 4MM X 6CM COIL (DLX100406, 31131286) COULD NOT BE PUSHED THROUGH A SL-10 MICROCATHETER (MC). THE COILS BEFORE AND AFTER COULD BE PUSHED THROUGH THE SAME CATHETER INTO THE ANEURYSM WITHOUT ANY PROBLEMS. THERE WAS A 10-MINUTE PROCEDURAL DELAYS DUE TO THE EVENT, THE DELAY WAS NOT CLINICALLY SIGNIFICANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT THE RESISTANCE WAS FELT MID TO DISTAL OF THE MICROCATHETER. THERE WAS DAMAGE NOTED ON THE DEVICE. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20201370 ↗
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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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