ULTIPAQ CERECYTE CFS100208-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528000150), received between Sep 28, 2016 and Nov 27, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2017Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, TWO ULTIPAQ COILS ((B)(4)AND (B)(4)) COULD NOT BE INTRODUCED INTO THE EXCELSIOR SL-10 MICROCATHETER. DURING ANALYSIS, LOT S11458 WAS FOUND TO BE KINKED AND LOT S11705 WAS STRETCHED. THERE WAS A "BOUNCY RESISTANCE". OTHER COILS AND THE MICROWIRE WENT THROUGH THE MICROCATHETER WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE PRODUCT USING THE SAME MICROCATHETER. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND NEITHER THE MICROCATHETER NO THE ULTIPAQ COILS APPEARED DAMAGED. THE COILS WERE STILL ATTACHED TO THE DPU WHEN REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS A 10 MINUTE DELAY DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062315 ↗
• MalfunctionNov 27, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, TWO ULTIPAQ COILS ((B)(4)) COULD NOT BE INTRODUCED INTO THE EXCELSIOR SL-10 MICROCATHETER. DURING ANALYSIS, LOT S11458 WAS FOUND TO BE KINKED AND LOT S11705 WAS STRETCHED. THERE WAS A "BOUNCY RESISTANCE". OTHER COILS AND THE MICROWIRE WENT THROUGH THE MICROCATHETER WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE PRODUCT USING THE SAME MICROCATHETER. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND NEITHER THE MICROCATHETER NO THE ULTIPAQ COILS APPEARED DAMAGED. THE COILS WERE STILL ATTACHED TO THE DPU WHEN REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS A 10 MINUTE DELAY DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062302 ↗
• MalfunctionSep 28, 2016Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COILING OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM THE PHYSICIAN ATTEMPTED TO INSERT A ULTIPAQ 10 CERECYTE COIL 2MM X 8MM (CFS10020830/C39579) INTO THE MICROCATHETER (TYPE/LOT UNKNOWN) HOWEVER THE COIL WOULD NOT ADVANCE. THE RESISTANCE WAS EXPERIENCED IN THE MID-SHAFT OF THE CATHETER. THE COIL AND THE MICROCATHETER WERE REPLACED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. PRIOR TO THE COMPLAINT COIL SEVEN COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER WITHOUT ANY RESISTANCE. THERE WERE NO DAMAGES NOTED ON THE COMPLAINT COIL OR THE MICROCATHETER PRIOR TO USE OR UPON REMOVAL. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS RELATED TO THE DEVICE OR REPORTED EVENT. THERE WERE NO ADVERSE EVENTS REPORTED. THE COMPLAINT PRODUCT WAS DISCARDED AND NOT AVAILABLE FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5983282 ↗