DELTAMAXX CERECYTE CDX181445-30Recalls & reported problems
Medos International Sàrl · DELTAMAXX microcoil DELTAMAXX 18 CERECYTE Coil 14mm x 45cm 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10878528008658), received between Jul 13, 2017 and Jul 13, 2017 — classified as 1 injury.
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 Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2017Premature Activation; Stretched; Premature Activation; Stretched
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE COIL INTRODUCER DAMAGE WAS REPORTED WHEN USING TWO DELTAMAXX COILS (CDX18246030/C38840 AND CDX18144530/C34584) AND ANOTHER DELTAMAXX COIL (CDX18144530/C36948) UNRAVELED AND PREMATURELY DETACHED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY. THE PATIENT WAS A FEMALE WHOSE VESSEL WAS MODERATELY TORTUROUS AND NOT CALCIFIED. THE DELTAMAXX COIL (CDX18246030/C38840) WAS USED AS THE FRAMING COIL HOWEVER "THE BALLOON COULD NOT BE HANDLED", SO THE PHYSICIAN TRIED TO RE-SHEATH THE COIL BUT INTRODUCER SHEATH BROKE AND THE COIL COULD NOT BE RE-SHEATHED. ANOTHER DELTAMAXX COIL (CDX18144530/C34584) WAS USED AS A FILLING COIL, BUT THE MICRO CATHETER SLID BACK PROXIMALLY AND THE COIL WOULD NOT FIT INTO THE CATHETER, SO THE PHYSICIAN TRIED TO RE-SHEATH THE COIL HOWEVER THE INTRODUCER SHEATH GOT BROKEN AND THE COIL COULD NOT BE RE-SHEATHED. EXCESSIVE FORCE WAS NOT USED WHEN HANDLING THE CATHETER AND THE COIL. AFTER THIS ISSUE, THE MICROCATHETER WAS REINSERTED. A DELTAMAXX COIL (CDX18144530/C36948) WAS INSERTED HOWEVER DUE TO INCORRECT POSITIONING OF THE CATHETER TIP IN THE ANEURYSM THE COIL DID NOT FIT IN THE
Patient problems: No Code Available
MAUDE report 6710457 ↗
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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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