DELTAMAXX DMX180625-20Recalls & reported problems
Medos International Sàrl · DELTAMAXX microcoil DELTAMAXX 18 Stretch Resistant Coil 6mm x 25cm 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10878528001710), received between May 18, 2018 and May 18, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Material Separation1
- Premature Separation1
- Stretched1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2018Material Separation; Stretched; Material Deformation; Premature Separation; Material Separation; Stretched; Material Deformation; Premature Separation
A REPORT WAS RECEIVED THAT THE SIZE OF THE 6X25 DELTAMAXX 18 (DMX18062520/C30717) STRETCH-RESISTANT THERMO-MECHANICAL COIL WAS DEEMED UNSUITABLE FOR THE TARGET LESION AND DURING ITS REMOVAL FROM THE PATIENT, THE DEVICE SEPARATED IN THE UNSPECIFIED MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED AS A UNIT. THE UNSPECIFIED GUIDING CATHETER WAS DISPLACED BECAUSE OF THE MANIPULATION, WHICH ULTIMATELY LEAD TO THE REINSERTION OF THE GUIDING CATHETER AND MICROCATHETER. THE SURGERY WAS DELAYED ONE HOUR DUE TO THE EVENT. THE EVENT ALSO RESULTED IN THE USAGE OF NEW PRODUCTS. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7525056 ↗
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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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