ULTIPAQ CERECYTE CFS100308-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528000235), received between Oct 30, 2017 and Oct 30, 2017 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT AN ULTIPAQ COIL (CFS10030830/C38900) WAS USED WITH AN ENPOWER DCB (LOT #F74248) DURING A SAH PROCEDURE IN THE AVM WHEN THE COIL COULD NOT BE DETACHED. THERE WAS NO MEDICAL INTERVENTION REQUIRED TO THE PATIENT AS A RESULT OF THIS EVENT. THERE WAS NO DAMAGE NOTED TO THE COIL PRIOR TO THE PROCEDURE OR UPON REMOVAL FROM THE PATIENT. NO KINKS OR BENDS WERE FOUND IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. REPORTEDLY, A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. BOTH A LOW BATTERY LIGHT AND A FAULT LIGHT WERE SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT HAD ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT THE USE OF EXCESSIVE FORCE. THE PATIENT WAS A (B)(6) FEMALE. THE DEVICE IS A BIOHAZARD AND WILL NOT BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6986439 ↗