DELTAMAXX CERECYTE CDX182060-30Recalls & reported problems
Medos International Sàrl · DELTAMAXX microcoil DELTAMAXX 18 CERECYTE Coil 20mm x 60cm 190cm Contents: 1 Detachable Coil System Coil Type: DELTAMAXX 18 CERECYTE Coil · Class 2 · Implant
All models of DELTAMAXX CERECYTE (13)
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 10878528008719), received between Nov 8, 2016 and Nov 8, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- 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.
MalfunctionNov 8, 2016Positioning Failure; Positioning Failure
THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT ILIAC ARTERY THE DELTAMAXX(CDX182060-30/C33979) COIL COULD NOT BE DETACHED. THE PATIENT'S VESSELS WERE MILDLY TORTUROUS AND NOT CALCIFIED. THERE WERE COILS (PRESIDIO18/DELTAMAXX 20MM, AZUR), A SHEATH INTRODUCER (MEDKIT), A GUIDING CATHETER (CERULEAN G50/G40, MEDIKIT), A GUIDEWIRE (RADIFOCUS, TERUMO), A MICROCATHETER (COILING SUPPORT, HI-LEX CORPORATION) AND AN ENPOWER CONTROL CABLE AND DETACHMENT BOX USED FOR THIS PROCEDURE. A Y-CONNECTOR WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS FOR PROPHYLAXIS A TYPE II ENDOLEAK TYPE. AN APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. A GUIDING CATHETER AND THE MICROCATHETER WERE DELIVERED TO THE LESION UNDER THE SHEATH. THE COIL EMBOLIZATION WAS PERFORMED AFTER THE TIP OF THE MICROCATHETER WAS ADVANCED TO THE LESION. AFTER 2 COILS WERE INSERTED, THE PHYSICIAN INSERTED THE COMPLAINT DELTAMAXX COIL AND PRESSED THE DETACHMENT BUTTON BUT THE COIL COULD NOT BE DETACHED. THE BUTTON WAS PRESSED SEVERAL TIMES BUT THE COIL COULD NOT BE DETACHED. IT WAS CONFIRMED THE POWER LIGHT DID NOT TURN ON. THE COIL WAS REPLACED WITH ANOTHER COIL (AZUR, TERUMO CLI
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6088251 ↗
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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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