DELTAMAXX DMX181040-20Recalls & reported problems
Medos International Sàrl · DELTAMAXX microcoil DELTAMAXX 18 Stretch Resistant Coil 10mm x 40cm 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 10878528001758), received between Sep 1, 2016 and Sep 1, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (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
- Unraveled Material1
- Unsealed Device Packaging1
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.
MalfunctionSep 1, 2016Unsealed Device Packaging; Unraveled Material; Unsealed Device Packaging; Unraveled Material
AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAMAXX COIL (DMX18104020/C10226) POUCH WAS OPENED, AND THE COIL WAS UNRAVELED IN THE PACKAGE. IT WAS REPORTED THAT THE COIL ARRIVED IN THE PACKAGING AND WAS SCANNED INTO THE SYSTEM AND PUT ON THE SHELF. WHEN THEY WERE READY TO USE THE COIL FOR THE CASE, THEY FOUND THE COIL WAS IN ITS PACKAGING, BUT THE PACKAGING WAS ALL TAPED UP. THE COIL WAS UNRAVELED IN THE PACKAGE. IT WAS REPORTED THAT THE POUCH WAS NEVER OPENED BY ANY OF THE STAFF. THERE HAD BEEN NO RECENT COIL UNRAVELED COMPLAINTS FROM THE SITE. THERE WAS NO REPORT OF THE BOX BEING DAMAGED. THERE WERE NO ADVERSE EVENTS OR DELAY IN THE CASE. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5920449 ↗
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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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