DELTAXSFT DLX100408Recalls & reported problems
Cerenovus, Inc. · DELTAXSFT Microcoil 10 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: DELTAXSFT 10 Stretch Resistant Coil 4mm (coil diameter) x 8cm (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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704077374), received between Jul 23, 2018 and May 7, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Stretched” (2 reports).
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
- Stretched2
- Fitting Problem1
- Premature Separation1
- Separation Failure1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2024Separation Failure; Separation Failure
AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 4MM X 8CM COIL (DLX100408, 30784459) DID NOT DETACH. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19259186 ↗MalfunctionJan 13, 2020Stretched; Premature Separation; Stretched; Premature Separation
THE HEALTHCARE PROFESSIONAL REPORTED SOME ISSUES WITH THE 4MM X 8CM DELTAXSFT 10 COIL (DLX100408 / L15596). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE 4MM X 8CM DELTAXSFT 10 COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED AND SEPARATED FROM THE DEVICE. BASED ON THE PRODUCT ANALYSIS ON 1/13/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9583598 ↗MalfunctionJul 23, 2018Stretched; Fitting Problem; Stretched; Fitting Problem
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE CONNECTION FROM THE DELTAXSFT 10 4MM X 8CM COIL (DLX100408 / L11308) TO THE DETACHMENT CABLE FOR THE DETACHMENT BOX DID NOT WORK. THERE WAS NO DAMAGE OBSERVED ON THE DEVICE. THERE WAS NO REPORT OF ADVERSE EVENT OR PATIENT CONSEQUENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7712979 ↗
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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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