CERECYTE PRESIDIO PC4182050-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528003328), received between Dec 13, 2016 and Jan 13, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2017Premature Activation; Stretched; Premature Activation; Stretched

  AS REPORTED BY HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION OF AN ANEURYSM AT THE LEFT INTERNAL ILIAC ARTERY THE SHEATH INTRODUCER OF THREE COILS; CASHMERE COIL (CRC14102530/C31865), PRESIDIO COIL (PC418205030/C24507) AND ONE DELTAMAXX COIL (CDX18206030/C38424) SPLIT OPEN WHEN THE COILS WERE DELIVERED INTO THE CATHETER. THE PATIENT WAS AN (B)(6) MALE WHOSE VESSELS WERE HEAVILY TORTUROUS AND CALCIFICATION WAS UNKNOWN. AN APPROACH WAS TAKEN FROM THE LEFT FEMORAL ARTERY TO THE TARGET LESION. A COIL (CASHMERE, LOT UNKNOWN) WAS PLACED IN THE LESION AND THEN THE COMPLAINT CASHMERE COIL (LOT# C31865) WAS USED AS THE SECOND COIL. HOWEVER THE SHEATH SPLIT OPEN AT APPROXIMATELY 20CM FORM ITS PROXIMAL PORTION WHEN THE COIL WAS DELIVERED INTO THE MICRO CATHETER, AND IT COULD NOT BE DELIVERED AT ALL. THEREFORE A PRESIDIO COIL LOT# C24507 (COMPLAINT PRODUCT2) WAS DELIVERED TO THE LESION FOR THE 2ND COIL BUT AGAIN THE SHEATH SPLIT OPEN AT APPROXIMATELY 20CM FORM ITS PROXIMAL PORTION WHEN THE COIL WAS DELIVERED INTO THE MICRO CATHETER. THE COIL WAS CHANGED TO ANOTHER COIL (PRESIDIO, SAME SIZE) AND IT COULD BE PLACED IN THE LESION SUCCESSFULLY. AFTER WHICH, THE DELTAMAXX LOT# C38424 (COMPL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6249174 ↗
• MalfunctionDec 13, 2016Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A GASTRIC VEIN, A PRESIDIO COIL (PC4182050-30/C41671) FAILED TO DETACH, THE DELIVERY WIRE BECAME COMPRESSED AND THEN THE COIL PREMATURELY DETACHED IN THE NON-CODMAN MICROCATHETER DURING WITHDRAWAL. THE GUIDING CATHETER WAS APPROACHED TO THE LIENAL VEIN AND THE MICROCATHETER WAS ADVANCED TO THE POINT OF BACK-FLOW. THE EMBOLIZATION WAS STARTED. AFTER A PRESIDIO 18 COIL WAS USED SUCCESSFULLY, THE COMPLAINT PRESIDIO 18 WAS USED. THE EMBOLIZATION WAS COMPLETED AS USUAL. IT WAS CONFIRMED THAT THE POWER LIGHT WAS ILLUMINATED AND THE PHYSICIAN PRESSED THE DETACHMENT BUTTON. HOWEVER, THE COIL WAS NOT DEPLOYED WHEN THE DELIVERY WIRE WAS WITHDRAWN. THE COIL WAS REINSERTED AND THE BUTTON WAS PRESSED AGAIN IN THE STATE OF THE DELIVERY WIRE BEING COMPRESSED A LITTLE DUE TO PUSHING THE COIL SEVERAL TIMES. THIS PROCESS WAS REPEATED FOUR TIMES, BUT THE COIL WAS NOT DEPLOYED. THEREFORE, THE PHYSICIAN TRIED TO REMOVE THE COIL; HOWEVER, THE COIL WAS DEPLOYED WHEN IT WAS WITHDRAWN APPROXIMATELY 10 CM. IT WAS FLUSHED BY SALINE SOLUTION AND COIL COULD BE REMOVED FROM THE MICROCATHETER COMPLETELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6169266 ↗