DELTAMAXX DMX181855-20Recalls & reported problems
Medos International Sàrl · DELTAMAXX microcoil DELTAMAXX 18 Stretch Resistant Coil 18mm x 55cm 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 10878528001833), received between May 10, 2017 and May 10, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
- Stretched1
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.
MalfunctionMay 10, 2017Stretched; Deformation Due to Compressive Stress; Stretched; Deformation Due to Compressive Stress
AS REPORTED BY A HEALTHCARE PROFESSIONAL DURING COIL EMBOLIZATION OF AN ENDOLEAK, A DELTAMAXX (DMX18185520/ C19940) COULD NOT BE RE-SHEATHED AND ANALYSIS REVEALED THE PROXIMAL SECTION OF THE COIL HAD UNREPORTED STRETCHING AND BUCKLING DAMAGE, AND THERE WAS A LOT OF TENSION WHEN ATTEMPTING TO ADVANCE A DELTAMAXX (DMX18165020/ C18057) FROM THE SHEATH. THE FIRST COIL HAD BEEN ADVANCED INTO THE SAC, BUT THE DOCTOR DID NOT LIKE THE CATHETER POSITION. THEY ATTEMPTED TO RE-SHEATH THE COIL, BUT THE COIL COULD NOT BE RE-SHEATHED. THE SECOND COIL WAS ADVANCED, BUT THE DOCTOR DID NOT LIKE THE SHAPE IT WAS TAKING, SO THE COIL WAS SUCCESSFULLY RE-SHEATHED TO REPOSITION THE CATHETER. WHEN THEY ATTEMPTED TO UN-SHEATH THE SECOND COIL, THEY FELT A LOT OF TENSION WHEN TRYING TO ADVANCE THE COIL FROM THE SHEATH. THEY EXCHANGED THE COIL TO A DIFFERENT COIL. NEITHER OF THE DEVICES APPEARED TO BE VISIBLY DAMAGED IN ANY WAY. THERE WERE NO ADVERSE PATIENT ISSUES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6557277 ↗
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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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