DELTAMAXX DMX180415-20Recalls & reported problems
Medos International Sàrl · DELTAMAXX microcoil DELTAMAXX 18 Stretch Resistant Coil 4mm x 15cm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10878528001697), received between Mar 7, 2017 and Dec 7, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2018Physical Resistance/Sticking; Physical Resistance/Sticking
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSMAL SUBARACHNOID HEMORRHAGE, THE PROWLER 14 45TIP 2MRK ((B)(4)) MICROCATHETER WAS ADVANCED TO THE TARGET VESSEL, BUT THE 4X5 DELTAMAXX SR PLAT 18SYS (DMX18041520/L11600) THERMO-MECHANICAL COIL ¿HITCHED¿ INTO THE MICROCATHETER AND IT WAS NOT POSSIBLE TO ADVANCE OR RETRACT. THE SYSTEM WAS REMOVED AND REPLACED WITHOUT INCIDENT. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCTS WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8142347 ↗MalfunctionMar 7, 2017Stretched; Stretched
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COILING PROCEDURE A DELTAMAXX SR PLAT 18 SYS 4 X 15 COIL STRETCHED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM AT AN UNKNOWN LOCATION. THE COIL HAD STRETCHED DURING DEPLOYMENT. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO USE. THERE WERE NO ADVERSE EVENTS HOWEVER THERE WAS A TIME DELAY CAUSED DUE TO THE REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6383366 ↗
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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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