DELTAXSFT DLX100304Recalls & reported problems
Cerenovus, Inc. · DELTAXSFT Microcoil 10 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: DELTAXSFT 10 Microcoil 3mm (coil diameter) x 4cm (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 10886704077343), received between Jun 6, 2019 and Jun 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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
- Separation Failure1
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.
MalfunctionJun 6, 2019Separation Failure; Separation Failure
AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION THERE WAS DIFFICULTIES DETACHING A DELTAXSFT10 3MM X 4CM COIL (DLX100304, L12179), REQUIRING ADDITIONAL MANIPULATION. THE COIL DID FINALLY DETACH. THERE WERE NO CONSEQUENCES TO THE PATIENT. THE EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED BEFORE USE AND THE RESULTS WERE OK. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT DID ILLUMINATE AND THERE WAS AUDIBLE SIGNAL BEEP. ALL CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. ALTHOUGH THERE WERE NO ALLEGED PRODUCT MALFUNCTIONS WITH THE ENPOWER DETACHABLE CONTROL BOX (DCB), THE DCB WAS NOT USED WITH SUBSEQUENT COILS. THE TARGET SITE WAS A CEREBRAL RIGHT MIDDLE ANEURYSM. NECK REMODELING WAS UTILIZED WITH A NON-CERENOVUS STENT. THE DCB WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8674808 ↗
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- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
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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