CERECYTE PRESIDIO PC4100626-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00878528003021), received between Dec 27, 2016 and Jan 17, 2024 — classified as 1 death, 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS WERE FOUND UNRAVELED/STRETCHED, A PRESIDIO 10 CERE 6MMX26CM (PC (B)(4) AND A MSPHERE 10 PLAT 4MMX7.5CM SPH (B)(4). A PRESIDIO 10 CERE 6MMX26CM COIL (PC (B)(4) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525829 ↗
• MalfunctionJan 17, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS WERE FOUND UNRAVELED/STRETCHED, A PRESIDIO 10 CERE 6MMX26CM (B)(4) AND A MSPHERE 10 PLAT 4MMX7.5CM (SPH10040020, 30443972). A PRESIDIO 10 CERE 6MMX26CM COIL (B)(4)) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525826 ↗
• MalfunctionOct 1, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION OF THE MIDDLE CEREBRAL ARTERY (M1 SEGMENT), A PRESIDIO 10 CERE 6MMX26CM COIL (PC410062630, 30399457) BECAME IMPEDED IN HUB PART WHEN IT TRYING TO ADVANCE WITHIN AN ECHELON10 MICROCATHETER (MC) DURING GENERAL ANESTHESIA SURGERY. THE PHYSICIAN RETRACTED IT (COIL WAS NOT USED IN PATIENT) AND REPLACED IT WITH A PRESIDIO 10 CERE 5MMX17CM COIL. THE NEW COIL DETACHED WITHOUT CHANGING THE MICROCATHETER. THERE WAS NOT PATIENT INJURED REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DAMAGE TO THE MC AT ANY TIME. THE COMPLAINT COIL DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561143 ↗
• MalfunctionSep 9, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED EMBOLIZATION PROCEDURE WITH THE TARGET LOCATION ON THE INTERNAL CAROTID ARTERY, IT WAS REPORTED THAT THE 6MM X 26CM PRESIDIO 10 CERECYTE COIL (PC410062630 / 30399457) WAS IMPEDED WHEN THE COIL WAS ADVANCING THROUGH THE CONCOMITANT ECHELON¿ 10 MICROCATHETER (MEDTRONIC). IT WAS REPORTED THAT THE COIL WAS SEVERAL CENTIMETERS AT THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN WITHDREW THE COIL; IT WAS STATED THAT THE COIL DID NOT DIRECTLY CONTACT THE PATIENT¿S BODY. THE PHYSICIAN SUCCESSFULLY REMOVED THE COMPLAINT COIL FROM THE PATIENT WITHOUT REMOVING THE MICROCATHETER; TARGET POSITION WAS NOT LOST. THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730) WAS USED AS REPLACEMENT AND IT WAS SUCCESSFULLY DETACHED. THE PATIENT DID NOT SHOW ANY UNUSUAL SYMPTOMS AFTER THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE. ADDITIONAL INFORMATION INDICATED THAT THE MICROCATHETER WAS NOT DAMAGED DURING THE MANIPULATION OF THE DEVICE. THE COMPLAINT COIL DID NOT APPEAR DAMAGE. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451491 ↗
• MalfunctionMay 10, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, WHEN THE 6MM X 26CM PRESIDIO 10 CERECYTE COIL (PC410062630 / K10342) REACHED THE TARGET POSITION, IT COULD NOT BE DETACHED. THE PHYSICIAN REMOVED IT FROM THE PATIENT¿S BODY AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11800981 ↗
• MalfunctionNov 18, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM EMBOLIZATION PROCEDURE, THE 6MM X 26CM PRESIDIO 10 CERECYTE COIL ((B)(4) / S13418) COULD NOT ADVANCE OUT OF THE MICROCATHETER TO BE DETACHED WHEN IT WAS DELIVERED TO THE TARGET CEREBRAL POSITION. A NEW COIL WAS USED AS A REPLACEMENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. IT WAS REPORTED THAT ADDITIONAL INFORMATION RELATED TO THE EVENT WAS NOT OBTAINABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION, THE EMBOLIC COIL WAS OBSERVED TO BE KINKED INSIDE THE COIL INTRODUCER. BASED ON THE PRODUCT ANALYSIS FROM 11/18/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10864557 ↗
• MalfunctionMay 19, 2020Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 6MMX26CM PRESIDIO 10 CERE COIL (PC410062630, L15312) COULDN¿T ADVANCE IN THE Y CONNECTOR. THE PHYSICIAN CHANGED TO ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. THE CEREBRAL TARGET POSITION WAS NOT LOST. BEFORE THIS PROBLEM COIL, THERE WERE TWO UNSPECIFIED COILS (8X30 AND 7X30) IMPLANTED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE DEVICE ANALYSIS ON THE PRODUCT RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10069890 ↗
• MalfunctionOct 30, 2018Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE USER ENCOUNTERED RESISTANCE WHILE ADVANCING THE 6MM X 26CM PRESIDIO 10 CERE (PC410062630/C35483), 7MM X 30CM PRESIDIO 10 CERE (PC410073030/S10163), AND THE 7MM X 20CM MICRUSPHERE XL (SSR10072020/S13782) THROUGH THE PROXIMAL SHAFT OF THE PROWLER SELECT PLUS (606S255X/17674174) MICROCATHETER. THE ISSUE REQUIRED THAT THE COILS BE REMOVED AND REPLACED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PROCEDURAL DELAY WAS LESS THAN 30 MINUTES. THE DEVICES WERE PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE CONCOMITANT MICROCATHETER DID NOT KINK OR BEND AT ANY TIME. A 10MM X 34CM PRESIDIO COIL AND COMPETITOR COILS WERE USED SUCCESSFULLY WITH THE CONCOMITANT MICROCATHETER PRIOR TO AND FOLLOWING THE ENCOUNTERED RESISTANCE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DISTAL PORTION OF THE 6MM X 26CM PRESIDIO EMBOLIC COIL WAS KINKED, THE DISTAL PORTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019905 ↗
• MalfunctionJun 6, 2018Break; Kinked; Stretched; Break; Kinked; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PRESIDIO 10 COIL ((B)(4)/UNKNOWN LOT) WAS USED AS THE FIRST OR SECOND COIL DURING A PROCEDURE WHEN THE COIL COULD NOT BE ADVANCE OR RETRIEVED BY THE PHYSICIAN. NOTE: SEVERAL ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION, BUT A RESPONSE HAS NOT BEEN RECEIVED TO DATE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE FORWARDED WITHIN 30 DAYS OF RECEIPT. THIS COMPLAINT WAS DEEMED MDR REPORTABLE AS A RESULT OF DEVICE EVALUATION RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7573706 ↗
• MalfunctionDec 6, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PRESIDIO 10 COIL (PC410062630/S10208) WAS USED DURING A PROCEDURE WHEN THE COIL COULD NOT BE DETACHED. THE PHYSICIAN WITHDREW THE COIL AND USED ANOTHER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089098 ↗
• MalfunctionSep 21, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PRESIDIO10 COIL (PC410062630/S10208) WAS USED DURING A COIL EMBOLIZATION PROCEDURE WHERE THE COIL COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN AND ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6884060 ↗
• MalfunctionAug 14, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PRESIDIO 10 COIL (PC410062630/ C32105) FAILED TO DETACH. THE PROCEDURE WAS COIL EMBOLIZATION OF A WIDE NECK VA-AN (6MM) ANEURYSM. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT IT WOULD NOT DETACH, HOWEVER, THE POWER LIGHTS ILLUMINATED. THE DELIVERY WIRE WAS WITHDRAWN A LITTLE AND IT WAS PUSHED AGAIN, BUT THE ISSUE CONTINUED. THE COIL CONNECTOR AND CONNECTION BETWEEN THE ENPOWER BOX AND CABLE WERE RECONNECTED SEVERAL TIMES, BUT THE ISSUE CONTINUED. ALL CONNECTIONS FIT PROPERLY WITHOUT NEED FOR EXCESSIVE FORCE. THE PRESIDIO WAS REPLACED WITH A COMPETITOR¿S COIL. THE PRESIDIO DID NOT APPEAR DAMAGED AT ALL DURING THE PROCEDURE. THE DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED AND IT WAS CONFIRMED THAT THE LAMP ILLUMINATED. THE SAME CABLE WAS LATER USED IN THE PROCEDURE TO DETACH A DELTAPLUSH COIL WITHOUT ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6791714 ↗
• MalfunctionMay 5, 2017Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE EMBOLIZATION PROCEDURE A PRESIDIO10 CERE 7MM X 30CM AND PRESIDIO10 CERE 6MM X 26CM AND A COIL WERE BLOCKED IN AN UNKNOWN MICROCATHETER. THE PROCEDURE WAS COMPLETED USING SAME LIKE PRODUCTS. THERE WERE NO ADVERSE EVENTS. IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF SUBARACHNOID HEMORRHAGE PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE COMPLAINT PRODUCTS ARE AVAILABLE FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6548652 ↗
• InjuryMar 16, 2017Premature Activation; Difficult to Remove; Stretched; Premature Activation; Difficult to Remove; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY ANEURYSM, AN ECHELON 10 CATHETER KICKED BACK DURING THE DEPLOYMENT OF THE LAST LOOP OF THE PRESIDIO COIL (PC410062630/S10283), AND DURING ATTEMPTED RETRIEVAL OF THE COIL, THE COIL BECAME ENTANGLED WITH PREVIOUSLY IMPLANTED COIL, STRETCHED AND DETACHED INSIDE THE CATHETER, WITH A STRAND OF THE COIL REMAINING IN THE PARENT VESSEL. THE EVENT DID NOT RESULT IN DISRUPTION/REDUCTION OF ARTERIAL BLOOD FLOW, AND THE PATIENT WAS NOT SYMPTOMATIC DURING THE EVENT. THE DOCTOR HAD DEPLOYED THE PRESIDIO IN THE ANEURYSM WHEN THE CATHETER KICKED BACK DURING THE DEPLOYMENT OF THE LAST LOOP. WHEN THE DOCTOR TRIED TO RETRIEVE THE COIL FOR RE-DEPLOYMENT, THE COIL COULD NOT BE RETRIEVED, AND IT WAS LATER FOUND THAT THE COIL HAD STRETCHED AND DETACHED INSIDE THE CATHETER ITSELF MAKING THE COIL RETRIEVAL IMPOSSIBLE. A STRAND OF THE COIL WAS IN THE PARENT ARTERY CONNECTED TO PREVIOUSLY IMPLANTED COIL. EFFORTS TO RETRIEVE THE COIL WERE UNSUCCESSFUL, AND THE DOCTOR FINALLY DEPLOYED A CAROTID WALL STENT AND STABILIZED THE COIL INSIDE THE ARTERY. EFFORTS TO RETRIEVE THE COIL WERE UNSUCCESSFUL. IT WAS REPORTED THAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6409134 ↗
• DeathMar 3, 2017Premature Activation; Stretched; Positioning Problem; Migration; Premature Activation; Stretched; Positioning Problem; Migration

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, WHEN THE PRESIDIO COIL (PC410062630 / S10781) WAS INSIDE THE 6MM ANTERIOR COMMUNICATING ARTERY ANEURYSM WHEN THE PHYSICIAN SAW THAT A PART OF THE COIL HAD PROTRUDED OUTSIDE THE ANEURYSM, BLOCKING THE ARTERY. DURING AN ATTEMPT TO RE-LOCATE THE COIL (STILL ATTACHED TO THE DEVICE POSITIONING UNIT) INTO THE STRYKER SL-10 MICROCATHETER, THE COIL BECAME PREMATURELY DETACHED. AN ATTEMPT TO SNARE THE COIL HAD BEEN UNSUCCESSFUL, AND THE COIL REMAINED PROTRUDING OUT OF THE ANEURYSM INTO THE PARENT ARTERY. THE EVENT RESULTED IN THE ARTERIAL (A1) THROMBOEMBOLISM FROM THE ANEURYSM VESSEL TO THE MIDDLE CEREBRAL ARTERY ON THE SAME SIDE AND CEREBRAL DEATH. THE PATIENT WAS LATER DISCONNECTED FROM LIFE SUPPORT MEASURES AND EXPIRED. THE DATE OF THE DEATH WAS NOT PROVIDED. THE PRESIDIO WAS THE FIRST COIL IMPLANTED. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

  Patient problems: Death; Infarction, Cerebral; Occlusion; Stroke/CVA; Thromboembolism

  MAUDE report 6377097 ↗
• MalfunctionDec 27, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COIL EMBOLIZATION AT THE VERTEBRAL ARTERY DISSECTION THE SYSTEM READY LIGHT OF A PRESIDIO COIL ((B)(4)) DID NOT ILLUMINATE AND HENCE THE COIL COULD NOT BE DETACHED. THE PATIENT WAS A (B)(6) YEAR-OLD MALE WHOSE VESSELS WERE MODERATELY TORTUROUS AND MODERATELY CALCIFIED. THE PRE-INSERTION ELECTRICAL CHECK WAS CONDUCTED BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. THE PRESIDIO WAS REPLACED WITH A NEW COIL (SAME CATALOG #). HOWEVER THE LIGHT DID NOT ILLUMINATE. THEREFORE THE CABLE (LOT UNKNOWN) WAS CHANGED BUT THE ISSUE CONTINUED. FINALLY THE LIGHT ILLUMINATE WHEN THE ENPOWER BOX (LOT UNKNOWN) WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES. THE PRODUCT (LOT# C38482) WILL BE RETURNED FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6204580 ↗