CERECYTE PRESIDIO PC4100412-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00878528003007), received between Oct 13, 2016 and Dec 14, 2020 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Kinked” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION TO THE LEFT INTERNAL CAROTID ARTERY (ICA), A 4MMX11.5CM PRESIDIO 10 CERE COIL (PC410041230, 459685) WAS UNABLE TO BE RELEASED. THE PHYSICIAN SWITCHED TO ANOTHER NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NOT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DETACHABLE CONTROL BOX (DCB) WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS AND THE SAME CABLE WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THERE WAS NO COIL STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. THERE WAS NO ADDITIONAL INTERVENTION NEEDED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS SIMPLY WITHDRAWN WITH THE PUSHER. IT WAS NOT NECESSARY TO REMOVE THE HEADWAY 17 MICROVENTION CATHETER. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS A 20-MINUTE PROCEDURAL DELAY DUE TO THE EVENT. THE CONCOMITANT DEVICES FUNCTION AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003190 ↗
• MalfunctionJul 14, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM EMBOLIZATION PROCEDURE, THE 4MM X 11.5CM PRESIDIO 10 CERECYTE COIL (PC410041230 / S12815) COULD NOT BE DETACHED. THE PHYSICIAN WITHDREW THE COMPLAINT COIL AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT AND PATIENT COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273813 ↗
• MalfunctionNov 12, 2019Material Separation; Material Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 4MMX11.5CM PRESIDIO 10 CERE COIL (PC410041230, S13271), WAS BEING USED AS THE FIRST COIL. HOWEVER, THERE WAS A ¿DETACH CONNECT DEFECT¿. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311392 ↗
• MalfunctionOct 2, 2019Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 4MMX11.5CM PRESIDIO 10 CERE COIL (PC410041230, S13271) WAS BEING USED AS A FIRST COIL, HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNKNOWN MICROCATHETER AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9146871 ↗
• MalfunctionMar 27, 2018Kinked; Material Separation; Kinked; Material Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, ABNORMAL FRICTION WAS ENCOUNTERED BETWEEN THE COIL INTRODUCER AND COIL DELIVERY SYSTEM OF A 4MM X 10 CM DELTAPAQ CERE ((B)(4)) THERMO-MECHANICAL COIL AND A 4 MM X 11.5 CM PRESIDIO 10 CERE (PC410041230/UNKNOWN LOT) THERMO-MECHANICAL COIL. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372768 ↗
• MalfunctionJan 3, 2018Kinked; Stretched; Kinked; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT, DURING A PROCEDURE, A PRESIDIO10 7X30 COIL (PC410073030/C41431) COULD NOT BE ADVANCED THROUGH THE MICROCATHETER AND A PRESIDIO10 4X11.5 COIL (PC410041230/S10946) COULD NOT BE RE-SHEATHED. THE PHYSICIAN USED ANOTHER OF THE SAME SIZE COILS TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7161955 ↗
• MalfunctionAug 25, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PRESIDIO 10 COIL (PC410041230/C41462) COULD NOT BE DETACHED DURING THE PROCEDURE. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819837 ↗
• MalfunctionJan 17, 2017Kinked; Failure to Advance; Kinked; Failure to Advance

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE THE PRESIDIO COIL (B)(4) COULD NOT BE INSERTED INTO MICROCATHETER. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THERE WAS NO SIGNIFICANT CLINICAL DELAY TO THE PROCEDURE AS A RESULT OF THE ISSUE. THE DEVICE DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THE CONCOMITANT DEVICES DID NOT KINK OR BEND AT ANY TIME. THERE WERE NO DAMAGES ON ANY PART OF THE DEVICE WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. DURING RETURNED DEVICE INVESTIGATION THE EMBOLIC COIL WAS FOUND BUCKLED AND COMPRESSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6259080 ↗
• MalfunctionNov 15, 2016Knotted; Stretched; Knotted; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE RESISTANCE WAS EXPERIENCED WITH THE COMPETITORS MICROCATHETER WHEN USING A PRESIDIO COIL (PC410041230/C37677). THE PROCEDURE WAS THE COIL EMBOLIZATION FOR THE BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION FOR A PORTO PULMONARY VENOUS ANASTOMOSIS. THE PATIENT WAS A (B)(6) YEAR-OLD FEMALE WHOSE VESSELS WERE MODERATELY TORTUROUS AND MILDLY CALCIFIED. THE MICRO CATHETER WAS APPROACHED TO THE TARGET LESION WHICH WAS PRE- BRTO DEVELOPED AT THE COLLATERAL PATHWAY. THE COIL EMBOLIZATION WAS PERFORMED WITHOUT THE Y CONNECTOR AND THE CONTINUANCE FLOW. A PRESIDIO COIL 4*11.5 (LOT UNKNOWN) WAS INSERTED AS 1ST COIL FOR ANCHORING. AFTER WHICH THE COMPLAINT PRESIDIO WAS INSERTED INTO THE MICRO CATHETER BUT THE DELIVERY WIRE COULD NOT BE ADVANCED AT THE MIDDLE OF THE CATHETER. THEREFORE THE COIL WAS RETRIEVED ONCE AND THE MICRO CATHETER WAS FLUSHED. THE COIL WAS REINSERTED INTO THE CATHETER BUT IT GOT STUCK AT THE SAME PORTION. THE COIL WAS RETRIEVED AGAIN. THEN A MICRO WIRE (14) WAS PASSED THROUGH THE MICRO CATHETER WITHOUT ANY PROBLEM. WHEN COIL WAS REINSERTED INTO THE CATHETER, IT GOT STUCK. THE COIL WAS REPLACED WITH ANOTH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6104923 ↗
• MalfunctionNov 8, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A C-PRESIDIO10 (PC4100412-30/C37495) WAS USED WITH AN ENPOWER CONTROL CABLE (ECB000182-00/P11613) DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM IN THE MIDDLE CEREBRAL ARTERY. DURING THE PROCEDURE, THE GREEN SYSTEM READY LIGHT OF THE COMPLAINT PRODUCTS DID NOT ILLUMINATE AND THE COIL FAILED TO DETACH. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER PRODUCT. REPORTEDLY, THE PATIENTS INFORMATION IS UNKNOWN AND THE LEVEL OF TORTUOUSNESS AND CALCIFICATION OF THE PATIENTS VESSEL ARE ALSO UNKNOWN. NO REPORT OF THE OTHER DEVICE USED IN THE PROCEDURE IS AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURES WERE CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. THE PRODUCTS ARE NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6085663 ↗
• MalfunctionNov 1, 2016Failure to Advance; Failure to Advance

  IT WAS REPORTED BY A CONTACT AT THE USER FACILITY THAT DURING A COIL EMBOLIZATION OF A RUPTURED ANEURYSM AT THE RIGHT POSTERIOR COMMUNICATING ARTERY THE PHYSICIAN EXPERIENCED RESISTANCE WHEN USING THREE PRESIDIO COIL ((B)(4)/LOT# C18183, C19118 AND C20979) AND A PROWLER SELECT PLUS CATHETER (606S155FX/17358075). THE ANEURYSM MEASURED 10 MM X 4 MM X 4 MM. A PROWLER SELECT LP ES WAS SELECTED AS THE MICRO CATHETER. THE ANEURYSM WAS ACCESSED WITHOUT INCIDENT USING A SYNCHRO GUIDE WIRE. THE PROWLER SELECT MICRO CATHETER WAS THEN TRACKED OVER THE WIRE AND INTO THE ANEURYSM WITHOUT INCIDENT. THE PHYSICIAN THEN ATTEMPTED TO INSERT A PRESIDIO MICROCOIL 4 X 11.5 (LOT# C18183). UPON INTRODUCTION INTO THE MICRO CATHETER RESISTANCE WAS ENCOUNTERED IN THE PROXIMAL SHAFT OF THE CATHETER AND THE COIL WAS UNABLE TO BE PUSHED DISTALLY. THE PHYSICIAN THEN REMOVED THE PRESIDIO MICROCOIL. THE PHYSICIAN THEN USED THE SYNCHRO GUIDE WIRE TO RE-ACCESS THE ANEURYSM ENSURING THAT THE MICRO CATHETER LUMEN WAS INTACT. THE PHYSICIAN THEN RE-ATTEMPTED TO INTRODUCE THE PRESIDIO MICROCOIL WITHOUT SUCCESS, AS THE SAME RESISTANCE ISSUE WAS EXPERIENCED. THE PHYSICIAN THEN REQUESTED THAT A NEW PRESIDIO 4X11.5 MICROCOI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6070425 ↗
• MalfunctionOct 13, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION THE PRESIDIO COIL (PC410041230/C23787) COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN AND USED A NEW COIL (LOT UNKNOWN) TO COMPLETE THE PROCEDURE. PROCEDURE DETAILS AND PATIENT INFORMATION ARE UNKNOWN. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6025451 ↗