CERECYTE PRESIDIO PC4181034-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00878528003229), received between Oct 2, 2016 and Oct 22, 2019 — classified as 7 malfunctions.

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

• MalfunctionOct 22, 2019Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 10MMX34CM PRESIDIO 18 CERE COIL (PC418103430, L14456) STRETCHED IN THE ECHELON 10 MICROCATHETER (MC). THE PHYSICIAN FOUND THE COIL COULDN¿T ADVANCE IN MICROCATHETER, THEN PULLED IT BACK OUTSIDE OF THE PATIENT WITH THE MICROCATHETER TOGETHER. CHANGED TO A NEW CATHETER (STILL USE AN ECHELON 10) AND A NEW 10MM X 20MM COMPETITOR¿S COIL TO COMPLETE THE OPERATION SUCCESSFULLY. AFTER THE OPERATION, THE PHYSICIAN PULLED THE PROBLEM COIL OUT OF THE PREVIOUS MICROCATHETER, AND FOUND THE COIL ALREADY STRETCHED. NO PATIENT INJURED WAS REPORTED. THE TARGET POSITION WAS LOST, BECAUSE THE MICRO CATHETER WAS PULLED OUT SIDE OF THE PATIENT¿S BODY AND CHANGED TO A NEW CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217967 ↗
• MalfunctionMay 9, 2019Stretched; Premature Separation; Stretched; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTERVENTIONAL EMBOLIZATION PROCEDURE TARGETING A 10 MM X 9 MM ANEURYSM WITH A 7 MM NECK AT THE ANTERIOR CEREBRAL ARTERY (ACA), THE 10 MM X 34 CM PRESIDIO 18 CERECYTE COIL (PC418103430 / L14084) COULD DID NOT FULLY ENTER THE TARGET LESION AND COULD NOT BE DELIVERED TO THE SECOND HALF OF THE ANEURYSM. DURING THE ADVANCEMENT INTO THE ANEURYSM, THE COIL BECAME STRETCHED AND PREMATURELY DETACHED DURING THE ATTEMPT TO ADJUST THE COIL POSITION. THE ENTIRE COIL WAS WITHDRAWN, REMOVED, AND REPLACED; NO ADDITIONAL DAMAGE WAS NOTED ON THE COIL. THERE WAS NO ISSUE OR DIFFICULTY WITH COIL POSITIONING, NO REPORT OF RESISTANCE/FRICTION BETWEEN THE COIL AND THE HEADWAY® 17 MICROCATHETER (MICROVENTION), NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED, NO RESISTANCE WAS REPORTED AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER . IT WAS CONFIRMED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS THAT COULD HAVE CONTRIBUTED TO THE COIL BECOMING STRETCHED. THE MICROCATHETER WAS NOT REPOSITIONED OVER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597881 ↗
• MalfunctionOct 9, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PRESIDIO18 COIL ((B)(4)/C26071) WAS STRETCHED DURING A PROCEDURE. THE PHYSICIAN REMOVED THE COIL SAFELY AND USED ANOTHER OF THE SAME SIZE COIL TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6930891 ↗
• MalfunctionJun 16, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE TWO PRESIDIO-18 COILS (PC418103430/C32334 AND PC418113730/C26955) FAILED TO DETACH WHEN BEING USED WITH TWO ENPOWER CONNECTING CABLES (ECB00018200/ LOT# C28985 AND P10211). THE PROCEDURE WAS THE COIL EMBOLIZATION OF AN UN-RUPTURED ANEURYSM. THE COMPLAINT COIL 1 (PC418103430/C32334) WAS INSERTED BUT THE COIL COULD NOT BE POSITIONED PROPERLY, THEREFORE, THE COIL WAS REMOVED FROM THE PATIENT. THE COMPLAINT COIL 2 (PC418113730/C26955) WAS CONNECTED TO THE COMPLAINT CABLE (ECB00018200/C28985) FOR INSERTING THE AND DETACHING, HOWEVER THE POWER LIGHT DID NOT ILLUMINATE. THE COIL AND CABLE WERE RECONNECTED SEVERAL TIMES BUT THE COIL COULD NOT BE DETACHED. THE COMPLAINT COIL 2 (PC418113730/C26955) WAS ALSO CONNECTED THE COMPLAINT CABLE (ECB00018200/P10211) BUT THE POWER LIGHT DID NOT ILLUMINATE. THEREFORE, THIS COIL WAS ALSO REMOVED. BOTH THE COMPLAINTS COILS WERE CONNECTED TO BOTH THE COMPLAINT CABLES SEVERAL TIMES HOWEVER THE POWER LIGHT DID NOT ILLUMINATE. REPORTEDLY THE DETACHMENT BOX WAS OLD (MANUFACTURED IN 2010), AND PER THE HEALTHCARE PROFESSIONAL SEEMED TO THE PROBLEM BUT THERE WAS ONLY ONE DETACHMENT BOX AT THE SITE A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6646135 ↗
• MalfunctionJun 8, 2017Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION FOR CORONARY AVF, A PRESIDIO COIL (PC418103430/ S10882) PREMATURELY DETACH DURING THE PROCEDURE. THE COIL WAS PLACED IN THE LESION. THE PHYSICIAN WANTS TO CONFIRM THAT THE COIL WAS PROPERLY DETACHED AT THE DETACHMENT POINT. 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/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. THE PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE PHYSICIAN WANTS TO CONFIRM THAT THE COIL WAS PROPERLY DETACHED AT THE DETACHMENT POINT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6622891 ↗
• MalfunctionApr 17, 2017Entrapment of Device; Fracture; Material Separation; Physical Resistance; Entrapment of Device; Fracture; Material Separation; Physical Resistance

  THE CONTACT FROM THE FACILITY REPORTED THAT THERE WAS STRONG RESISTANCE WHEN ADVANCING A PRESIDIO (PC4181034-30, S10232) AND A DELTAMAXX (CDX181242-30, C41490) COIL THROUGH THE PROGREAT (TERUMO, DETAILS UNKNOWN) MICROCATHETER. THE PROCEDURE WAS THE COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY. THE PATIENT¿S VESSEL WAS HEAVILY TORTUROUS AND NOT CALCIFIED. A GUIDING CATHETER (PALANT 6FR) AND A Y-CONNECTOR (GOOD TEC) WERE ALSO USED IN THE PROCEDURE. PRE-DEPLOYMENT ELECTRICAL CHECK FOR BOTH COILS INDICATED THE POWER WAS SUPPLIED NORMALLY, AND THE TIP OF THE SHEATH INTRODUCERS WERE INSERTED INTO THE MICRO CATHETER AND COIL DELIVERY WIRES WERE INSERTED FOR BOTH COILS. HOWEVER, THERE WAS STRONG RESISTANCE FELT SINCE TIP OF THE SHEATH INTRODUCER WAS INSERTED INTO THE MICRO CATHETER. THE COILS WERE REMOVED FROM THE PATIENT¿S BODY WITHOUT REMOVING THE MICROCATHETER. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6497887 ↗
• MalfunctionOct 2, 2016Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN EMERGENCY COIL EMBOLIZATION PROCEDURE FOR ALIMENTARY CANAL BLEEDING A PRESIDIO 18 (PC4181034-30/ C14003) COIL GOT DAMAGED WHEN THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS 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. 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 MICROCATHETER. THE PATIENT'S INFORMATION IS UNKNOWN. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5992852 ↗