CERECYTE PRESIDIO PC4181240-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878528003243), received between Jun 28, 2017 and Jun 11, 2019 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM, THE 12MM X 40CM PRESIDIO 18 CERECYTE COIL ((B)(4)/ L14086) COULD NOT BE DETACHED USING THE ENPOWER CONTROL CABLE AND THE ENPOWER DETACHMENT CONTROL BOX (DCB). A PRE-DEPLOYMENT CHECK WAS PERFORMED, AND THE LOW BATTERY AND FAULT LIGHTS WERE NOT OBSERVED. IT WAS REPORTED THAT UPON PRESSING THE POWER BUTTON, ALL THE LIGHTS ILLUMINATED ON THE ENPOWER DCB, BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. THE COIL WAS SUCCESSFULLY REMOVED AND REPLACED; THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM AND NOT STRETCHED WHEN IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME ENPOWER DCB AND ENPOWER CONTROL CABLE; THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION; NO PROCEDURAL DELAY. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689512 ↗
• MalfunctionJan 15, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 12 MM X 40 CM PRESIDIO 18 CERECYTE COIL (PC418124030 / S11222) FAILED TO RESHEATH. THE COIL WAS REPLACED. IT WAS CONFIRMED THAT THE SHEATH INTRODUCER WAS NOT KINKED/BENT, COMPRESSED, CRACKED OR SEPARATED PRIOR TO THE USE OF THE COIL. NO DAMAGE WAS NOTED ON THE INNER PACKAGING OF THE DEVICE. THERE WAS NO REPORT OF ANY PROCEDURAL DELAY FROM THE REPORTED ISSUE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE. THE PRESIDIO 18 CERECYTE COIL WAS RETURNED FOR EVALUATION AND ANALYSIS. THE COIL WAS OBSERVED TO BE KINKED AND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8250621 ↗
• MalfunctionJul 10, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A BALLOON-ASSISTED COIL EMBOLIZATION OF A 4.4 MM X 2.2 MM INCIDENTAL RECURRENT LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE 12 MM X 40 CM PRESIDIO 18 (PC418124030/C40510) THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM BECAME STUCK IN THE EXCELSIOR SL-10 (STRYKER) MICROCATHETER. THE CUSTOMER COULD NOT RECALL IF THE ISSUE REQUIRED THAT THE COIL AND MICROCATHETER BE REMOVED FROM THE PATIENT AS A UNIT; HOWEVER, IT WAS STATED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO REMOVAL. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. PRE-TREATMENT ANGIOGRAPHY REVEALED A LARGER, PERFUSED SECTION OF THE ANEURYSM BASE WITH A FREE LUMEN OF APPROXIMATELY 4.4 X 2.2 MM AND AN ANEURYSM WALL WITHOUT BLOOD SUPPLY. ACTIVATED CLOTTING TIME (ACT) WAS INCREASED WITH HEPARIN TO > 200 SECONDS FOR THE COURSE OF THE PROCEDURE. APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY. ACCESS TO THE LEFT ICA WAS MADE VIA A 90 CM LONG 7F UNSPECIFIED SHEATH, A DAC44 (CONCENTRIC MEDICAL) DISTAL ACCESS CATHETER, AND AN EXCELSIOR SL-1

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7672985 ↗
• MalfunctionAug 24, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A LEFT SUBCLAVIAN ARTERY ANEURYSM, A PRESIDIO 18 COIL (PC418124030/ S10072) FAILED TO DETACH. THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED WITHOUT ANY PROBLEMS, BUT THE ENERGIZATION COULD NOT BE CONFIRMED WHEN THE CABLE WAS RECONNECTED AT THE TIME OF DEPLOYMENT. THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE). ALL CONNECTIONS HAD FIT PROPERLY WITHOUT NEED FOR EXCESSIVE FORCE. 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 THROUGH THE PROWLER SELECT PLUS MICROCATHETER. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PATIENT VESSEL WAS HEAVILY TORTUOUS AND HEAVILY CALCIFIED. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6816493 ↗
• MalfunctionJun 28, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE THE DELIVERY WIRE OF A PRESIDIO18 COIL (PC418124030/C34633) GOT KINKED AND THE COIL UNRAVELED. THE PROCEDURE WAS TYPE 2 ENDOLEAK EMBOLIZATION AT THE LUMBAR ARTERY. THE SHEATH INTRODUCER WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND THE GUIDING CATHETER WAS APPROACHED TO THE INTERNAL ILIAC ARTERY WITH THE MICRO CATHETER. APPROACH TO THE LUMBAR ARTERY FROM THE ILIOLUMBAR ARTERY WAS MADE, AND IT WAS ATTEMPTED TO EMBOLIZE THE ANEURYSM BEYOND IT. THE PRESIDIO 18 (COMPLAINT PRODUCT) WAS USED THE FRAMING COIL IN THE TARGET LESION BUT AS IT WAS OVERSIZED AND IT BECAME VERY DIFFICULT TO DELIVER THE COIL, THE PHYSICIAN TRIED TO RE-SHEATH THE COIL. WHEN THE PHYSICIAN PULLED THE DELIVERY WIRE TO WITHDRAW, IT GOT KINKED AND THE COIL COULD NOT BE RE-SHEATHED. THE MICROCATHETER WAS REMOVED AND THE DELIVERY WIRE WAS A LITTLE OUT OF THE SHEATH, THE PHYSICIAN TRIED TO RETRIEVE THE DELIVERY WIRE HOWEVER THE WIRE GOT KINKED AGAIN. WHEN ATTEMPTING TO RE-SHEATH THE COIL, THE COIL ENTANGLED INSIDE THE ANEURYSM AND UNRAVELED WHEN THE PHYSICIAN PULLED THE DELIVERY WIRE. THE PHYSICIAN EMBOLIZED THE LUMBAR ARTERY AND CONFIRMED THE STOP OF THE AR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6673367 ↗