CERECYTE PRESIDIO PC4100517-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00878528003014), received between Sep 28, 2016 and Jan 30, 2024 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Stretched” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A PRESIDIO 10 CERE 5MMX17CM COIL ((B)(6)). IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE 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 18610194 ↗
• MalfunctionJan 18, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 5MM X 17CM PRESIDIO 10 CERECYTE COIL ((B)(4) / 30429071) FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 18-JAN-2024, PER THE CERENOVUS SALES REPRESENTATIVE, NO ADDITIONAL INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18537234 ↗
• MalfunctionDec 28, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED INTERNAL CAROTID ARTERY (ICA) ANEURYSM EMBOLIZATION PROCEDURE, WITH THE (B)(6) FEMALE PATIENT UNDER GENERAL ANESTHESIA, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE COMPLAINT COIL, A 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730 / K10429) IN THE MICROCATHETER, BUT IT THE COIL BECAME IMPEDED IN THE HUB SECTION OF THE MICROCATHETER (UNSPECIFIED BRAND). IT WAS REPORTED THAT FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AND THE COMPLAINT DEVICE WAS NOT SUBJECTED TO EXCESSIVE FORCE. THE PHYSICIAN RETRACTED THE COIL; IT WAS NOT USED IN THE PATIENT AND IT DID NOT GO THROUGH THE MICROCATHETER. A NEW COIL WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL, THE EMBOLIC COIL WAS OBSERVED PROTRUDING FROM THE INTRODUCER AND IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 28 DEC 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13098589 ↗
• MalfunctionJun 21, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE, THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC (B)(4) / LOT# UNKNOWN) FAILED TO DETACH. THE PHYSICIAN SWITCHED TO ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033392 ↗
• MalfunctionJun 8, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730 / S15008) COULD NOT BE DETACHED WHEN IT WAS DELIVERED TO THE TARGET CEREBRAL POSITION. THE PHYSICIAN WITHDREW THE COIL ONLY (NOT MOVE THE MICROCATHETER) AND SWITCHED TO A NEW COIL (MEDTRONIC); THE REPLACEMENT COIL WAS REPORTED TO WORK SUCCESSFULLY. THEN THE PHYSICIAN THEN INSERTED THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 6253757) AND DELIVERED IT TO THE TARGET POSITION VIA THE 150CM X 5CM PROWLER SELECT PLUS (606S255X / 30487605). WHEN THE STENT COMPONENT WAS HALF DEPLOYED, THE PHYSICIAN THOUGHT THE POSITION SHOULD BE ADJUSTED. HE PLANNED TO WITHDRAW THE STENT BACK INTO THE MICROCATHETER, BUT THE ATTEMPT WAS NOT SUCCESSFUL. THE PHYSICIAN WITHDREW THE STENT AND THE MICROCATHETER FROM THE PATIENT. OUTSIDE THE PATIENT¿S BODY, THE MICROCATHETER WAS OBSERVED BENT. THE PHYSICIAN SWITCHED TO A NEW STENT (MEDTRONIC) AND MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958012 ↗
• MalfunctionDec 29, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM COIL EMBOLIZATION PROCEDURE, THE INDICATOR LIGHT OF THE DETACHMENT CONTROL BOX DID NOT WORK AND COULD NOT DETACH THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730 / K10430). THE DETACHMENT CONTROL BOX (DCB) WAS REPORTED TO HAVE FULL ELECTRICITY. THE COMPLAINT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE COIL WAS NOT IN STRETCHED CONDITION WHEN IT WAS REMOVED. THE PHYSICIAN SWITCHED TO A NEW 5MM X 17CM PRESIDIO 10 CERECYTE COIL TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL ENPOWER DCB AND ENPOWER CONTROL CABLE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED BEFORE THE ATTEMPT TO DETACH THE COMPLAINT COIL. THE FAULT LIGHT WAS NOT SEEN, AND THE SYSTEM READY LIGHT DID NOT ILLUMINATE. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT AND THE AUDIBLE SIGNAL BEEP WAS NOT HEARD. ALL CONNECTIONS FIT PROPERLY WITHOUT THE APPLICATION OF FORCE. THE EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089979 ↗
• MalfunctionJul 15, 2020Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE COIL COULDN¿T BE DETACHED. PHYSICIAN WITHDREW THE PROBLEM COIL OUTSIDE OF PATIENT, AND CHANGED ANTHER NEW COIL TO COMPLETE THE PROCEDURE. PROCEDURE NAME IS ANEURYSM EMBOLIZATION. THERE WAS NOT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275993 ↗
• MalfunctionJun 23, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL (B)(4) / S14305) FAILED TO BE DETACHED. THE PHYSICIAN REPLACED THE DETACHMENT CONTROL BOX, BUT THE ISSUE STILL PERSISTED. THE PHYSICIAN WITHDREW THE COIL FROM THE PATIENT¿S BODY AND REPLACED WITH ANOTHER 5MM X 17CM PRESIDIO 10 CERECYTE COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10186788 ↗
• InjuryJun 5, 2018Premature Activation; Stretched; Material Protrusion/Extrusion; Premature Activation; Stretched; Material Protrusion/Extrusion

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TO TREAT A RECURRING (RECANALIZED) 5 MM BASILAR TIP ANEURYSM THAT HAD BEEN PREVIOUSLY TREATED WITH AN ENTERPRISE STENT (CATALOG AND LOT NUMBERS UNAVAILABLE) THROUGH THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCA) WITH MICRUS COILS (CATALOG AND LOT NUMBERS UNAVAILABLE), THE PHYSICIAN DETERMINED THAT A SECOND STENT THROUGH THE LEFT PCA WAS NEEDED AND SUCCESSFULLY DEPLOYED A STRYKER ATLAS STENT THROUGH THE SL-10 MICROCATHETER. THE SL-10 MICROCATHETER WAS THEN EXCHANGED FOR THE PROWLER SELECT LP MICROCATHETER AND ACCESSED THE ANEURYSM. THE PRESIDIO 10 CERE 5 MM X 17 CM COIL (PC410051730 / S12089) WAS DEPLOYED INTO THE ANEURYSM AND DURING DEPLOYMENT OF THE COIL, THE MICROCATHETER PURCHASED INTO THE ANEURYSM AND WAS LOST SEVERAL TIMES. EACH TIME THE MICROCATHETER PURCHASED AND LOST, THE COIL WAS USED AS A GUIDEWIRE FOR THE MICROCATHETER TO CLIMB OVER AND BACK INTO THE ANEURYSM. AT ONE POINT, WITH 2 CM OF THE COIL IN THE ANEURYSM, THE COIL BECAME STUCK AND COULD NOT BE ADVANCED NOR RETRACTED. THE PHYSICIAN FORCIBLY REMOVED THE DEVICE POSITIONING UNIT (DPU) FROM THE MICROCATHETER AND AS A RESULT,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7570185 ↗
• MalfunctionJan 16, 2018Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION TO AN UNKNOWN TARGET SITE, A PRESIDIO 10 COIL (PC410051730, C36101) STRETCHED. ANOTHER COIL WAS USED WITH THE SAME UNKNOWN MICROCATHETER (MC) TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON THE PATIENT INJURY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WAS NO REPORT OF RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED/REPOSITIONED/WITHDRAWN. AFTER STRETCHING WAS NOTED, THE ENTIRE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED FROM THE MC WHILE THE MC REMAINED AT THE TARGET SITE. IT IS UNKNOWN IF OTHER COILS WENT THROUGH THE SAME MC WITHOUT RESISTANCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7196812 ↗
• MalfunctionNov 3, 2017Difficult To Position; Premature Activation; Material Separation; Stretched; Physical Resistance; Difficult To Position; Premature Activation; Material Separation; Stretched; Physical Resistance

  DURING THE ANEURYSM EMBOLIZATION, THE COIL COULD NOT BE SHAPED AS EXPECTED. THE SURGEON WITHDREW THE COIL TO FILL AGAIN BUT THE COIL COULD NOT BE ADVANCED. WITHDREW THE COIL AND IT WAS FOUND STRETCHED. USED ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON THE PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6998833 ↗
• MalfunctionAug 25, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE PRESIDIO COIL (PC410051730/C33692) STRETCHED WHEN FILLING DURING THE PROCEDURE. 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 6821922 ↗
• MalfunctionAug 25, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PRESIDIO 10 COIL (B)(4) STRETCHED WHEN FILLING DURING THE PROCEDURE. 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 6819861 ↗
• MalfunctionJul 19, 2017Premature Activation; Stretched; Premature Activation; Stretched

  IT WAS REPORTED THAT A PRESIDIO (PC410051730/ C37029) BECAME STUCK IN THE MIDDLE OF THE EXCELSIOR SL10 MICROCATHETER, AND DURING PRODUCT ANALYSIS IT WAS FOUND THAT THE COIL WAS SEPARATED FROM ITS SOLDER AND SOCKET RING AND WAS STRETCHED, AN ENTERPRISE2 (B)(4) PREMATURELY DEPLOYED AT THE MICROCATHETER HUB, AND A PROWLER SELECT PLUS (B)(4) HAD A TIP KINK ISSUE WHEN THE BOX WAS OPENED. THE PHYSICIAN USED ANOTHER SAME SIZE PRODUCTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO POTENTIAL PATIENT ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6725606 ↗
• MalfunctionFeb 15, 2017Difficult or Delayed Positioning; Material Protrusion/Extrusion; Difficult or Delayed Positioning; Material Protrusion/Extrusion

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION, THE PRESIDIO COIL (PC410051730/C38467) DETACHED AFTER PRESSING THE DETACH BUTTON SEVERAL TIMES ON THE ENPOWER DCB. HOWEVER THIS RESULTED IN AN INACCURATE PLACEMENT OF THE LAST LOOP OF THE COIL AS THE USER MOVED THE MICROCATHETER SEVERAL TIMES TO CHECK IF THE COIL WAS DETACHED. THE LAST LOOP OF THE COIL WAS THEREFORE OUTSIDE THE ANEURYSM IN THE PARENT VESSEL. THE PHYSICIAN TRIED TO PUSH IT BACK INTO THE ANEURYSM WITH THE MICROCATHETER BUT WAS UNSUCCESSFUL. NO FURTHER INTERVENTION WAS TAKEN WITH RESPECT TO THE COIL PROTRUSION. THERE WAS NO FLOW RESTRICTION AS A RESULT. THE OTHER COILS WERE DETACHED PROPERLY. THERE WAS NOT A SIGNIFICANT DELAY TO THE PROCEDURE AS A RESULT OF THE ISSUE. THE COIL DETACHED IN A FEW MINUTES. THERE WERE NO DAMAGES NOTED TO THE COIL/COIL DELIVERY SYSTEM OR DETACHMENT SYSTEM. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THERE WAS NO FAULT LIGHT AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE THE DETACHMENT LIGHT ILLUMINATED. THERE WAS AN AUDIBLE BEEP AT THE TIME OF THE DETACHMENT ATTEMPT. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT USE OF EXCESSIVE FORC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6333999 ↗
• MalfunctionFeb 6, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COIL EMBOLIZATION PROCEDURE A PRESIDIO COIL COULD NOT BE DETACHED. REPORTEDLY, AN ATTEMPT WAS MADE TO DETACH THE COIL WITH AN ENPOWER DCB AND CONTROL CABLE. THE PHYSICIAN USED A NEW COIL TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY AND NO DELAY IN PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6304691 ↗
• MalfunctionSep 28, 2016Failure to Advance; Failure to Advance

  IT WAS REPORTED BY A CONTACT AT THE USER FACILITY THAT A MICRUSPHERE 10 CERE, 5MM X 9.7CM COIL (CSP10050030/C33131) WAS THE FIRST COIL USED IN A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE MIDDLE CEREBRAL ARTERY. THE POWER LIGHT DID NOT ILLUMINATE DURING THE PRE-ELECTRICAL CHECK. THE ENPOWER CONTROL CABLE (ECB00018200/P11613) WAS REPLACED WITH ANOTHER ONE, HOWEVER THE LIGHT STILL DID NOT ILLUMINATE. THE MICRUSPHERE COIL WAS THEN REPLACED WITH A PRESIDIO 5MM X 17 CM COIL (PC410051730/C36208) AND THE ISSUE RESOLVED. HOWEVER THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE WHEN ADVANCING THE COIL THROUGH THE UNIDENTIFIED MICROCATHETER SHAFT, THE COIL WAS UNABLE TO BE ADVANCED. THE PRESIDIO COIL WAS REPLACED WITH ANOTHER COIL (SAME LOT NUMBER, SAME SIZE) AND THE MICROCATHETER WAS ALSO EXCHANGED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THE SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE REPORTED EVENT. IT WAS REPORTED THAT BOTH THE UNKNOWN MICROCATHETER AND UNKNOWN DETACHMENT CONTROL BOX WERE EXCHANGED DURING THE PROCEDURE. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THERE WERE NO VISIBLE DEFECTS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5982947 ↗