DELTAMAXX CERECYTE CDX181855-30Recalls & reported problems
Medos International Sàrl · DELTAMAXX microcoil DELTAMAXX 18 CERECYTE Coil 18mm x 55cm 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 10878528008696), received between Sep 28, 2016 and Sep 28, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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
- Premature Activation1
- 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.
MalfunctionSep 28, 2016Premature Activation; Stretched; Premature Activation; Stretched
AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE THE PHYSICIAN EXPERIENCED RESISTANCE WHEN USING DELTAMAXX COIL (CDX18185530/C33289) AND PROWLER SELECT PLUS CATHETER (606S255FX/17450085). THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM ON BOTH SIDES OF THE INTERNAL ILIAC ARTERY BEFORE EVAR. PATIENT WAS AN (B)(6) OLD MALE WHOSE VESSELS WERE HEAVILY TORTUROUS AND HEAVILY CALCIFIED. THE COMPLAINT DELTAMAXX COIL WAS THE 9TH COIL BEING USED IN THE PROCEDURE; THERE WAS STRONG RESISTANCE FELT BETWEEN THE COIL AND THE MICRO CATHETER. THEREFORE THE PHYSICIAN TRIED TO RETRIEVE THE COIL SLOWLY, BUT IT UNRAVELED. FURTHERMORE, THE COIL REMAINED IN THE MICRO CATHETER. THE COIL WAS REMOVED WITH THE MICRO CATHETER AS A UNIT. THE COIL WAS REPLACED WITH ANOTHER COIL (CATALOG # CDX18185530/LOT UNKNOWN). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY WITH 12 MICRUS COILS AND 10 TRUFILL COILS. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH WAS MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON TH
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5983258 ↗
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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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