DELTAMAXX DMX180835-20Recalls & reported problems
Medos International Sàrl · DELTAMAXX microcoil DELTAMAXX 18 Stretch Resistant Coil 8mm x 35cm 190cm Contents: 1 Detachable Coil System Coil Type: DELTAMAXX 18 Stretch Resistant Coil · Class 2 · Implant
Data updated Oct 18, 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 10878528001734), received between Feb 12, 2018 and Feb 12, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Kinked” (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 18, 2026.
Most reported problems
Device problems
- Kinked1
- Positioning 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.
MalfunctionFeb 12, 2018Positioning Failure; Kinked; Positioning Failure; Kinked
A REPORT WAS RECEIVED THAT DURING A COIL EMBOLIZATION OF A FUSIFORM BASILAR ARTERY ANEURYSM, THE PHYSICIAN ATTEMPTED TO DETACH THE 8 MM X 35 CM DELTAMAXX STRETCH RESISTANT THERMO-MECHANICAL COIL TWO TIMES WITHOUT SUCCESS. THE COIL WAS SUBSEQUENTLY RESHEATHED AND NOT USED. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE DELTAMAXX WAS THE FIRST COIL USED IN THE PROCEDURE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7263192 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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