CERECYTE PRESIDIO PC4181647-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528003281), received between Sep 7, 2016 and Aug 29, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PRESIDIO 18 COIL ((B)(4), C29738) WAS DIFFICULT TO POSITION IN THE SPLENIC ARTERY ANEURYSM AND THE SHEATH INTRODUCER WAS DAMAGED DURING ATTEMPT TO RE-SHEATH, AND A PRESIDIO 18 ((B)(4)/ C15917) LOOP PROTRUDED INTO THE PARENT VESSEL AND COULD NOT BE RE-SHEATHED. LOT C29738 WAS ATTEMPTED TO BE PLACE IN THE ANEURYSM, BUT IT KICKED BACK STRONGLY. THEREFORE, THE PHYSICIAN TRIED TO RE-SHEATH THE COIL, BUT THE SHEATH INTRODUCER BECAME DAMAGED AND COULD NOT RE-SHEATH THE COIL. THE COIL WAS REPLACED WITH ANOTHER ONE. LOT C15917 WAS USED FOR THE 3RD COIL, BUT THE LOOP WAS OUT OF THE MOTHER VESSEL FROM THE NECK AND THE COIL COULD NOT BE PLACED. THEREFORE, THE PHYSICIAN TRIED TO RE-SHEATH, THE COIL, BUT THE COIL WAS COULD NOT BE RE-SHEATHED. IT 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 THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6828719 ↗
• MalfunctionMar 28, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE TWO COILS A PRESIDIO 18 CERE 16MM X 47CM AND A PRESIDIO 18 CERE 18MM X 46 CM FAILED TO RE-SHEATH. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM AT THE LEFT SUBCLAVIAN WITH BYPASS. THE PATIENT WAS A (B)(6) MALE WHOSE VESSEL WAS HEAVILY TORTUROUS AND NOT CALCIFIED. THE PRESIDIO 18 COIL (PC4181846-30, C34513) WAS INSERTED INTO THE PROWLER MICROCATHETER (LOT UNKNOWN). THE COIL DID NOT FIT PROPERLY EVEN THOUGH THE PHYSICIAN TRIED IT SEVERAL TIMES; THE COIL WAS NOT WINDING WELL. THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COIL, HOWEVER THE ZIPPER SPLIT AND WAS UNABLE TO RE-SHEATH THE COIL. THE COIL WAS THE REPLACED WITH ANOTHER PRESIDIO 18 COIL (PC4181647-30, C40180). THE COIL WAS INSERTED INTO THE MICRO CATHETER. THIS COIL ALSO DID NOT FIT PROPERLY AND THE PHYSICIAN JUDGED THE COIL WAS NOT PLACED IN LESION. THE PHYSICIAN TRIED TO RE-SHEATH THE COIL BUT THE SHEATH INTRODUCER SPLIT OPEN WHEN THE DELIVERY WIRE WAS WITHDRAWN AND WAS UNABLE TO RE-SHEATH THE COIL. SINCE THE BLOOD FLOW WAS ALSO STRONG, AN AMPLATZER VASCULAR PLUG WAS PLACED IN THE PROXIMAL PORTION OF THE SUBCLAVIAN ARTERY. THE FLOW STILL REMAINED, THE MICRO CATHET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439206 ↗
• MalfunctionSep 13, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE COIL EMBOLIZATION OF AN ANEURYSM AT THE LEFT INTERNAL ILIAC ARTERY A PRESIDIO CERE COIL (PC418164730/C41367) FAILED TO DETACH. PATIENT WAS A (B)(6) MALE WHOSE VESSELS WERE MILDLY TORTUROUS AND MILDLY CALCIFIED. THE PRE-INSERTION ELECTRICAL CHECK WAS SUCCESSFUL AND THE COIL WAS PLACED WITHOUT ANY PROBLEM. HOWEVER WHEN THE DETACH BUTTON WAS PRESSED, THE DETACHMENT LIGHT DID NOT ILLUMINATE AND THE COIL DID NOT DETACH. THE COIL WAS REPLACED WITH A NEW ONE (DIFFERENT LOT#). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THE SAME CONNECTING CABLE AND DETACHMENT CONTROL BOX WERE USED WITH COILS PRIOR TO AND AFTER THE EVENT. 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 THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5945659 ↗
• MalfunctionSep 7, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE THE PHYSICIAN WAS UNABLE TO DETACH A PRESIDIO18 16X47 COIL (PC418164730/C38103) USING THE ENPOWER CABLE (ECB00018200/P12057). HE TRIED TO DETACH A PRESIDIO18 16X47 COIL (PC418164730/C38103), HOWEVER THE GREEN SYSTEM READY LIGHT DIDN'T ILLUMINATE WITH THE ENPOWER CABLE (ECB00018200/P12057). HE THEN USED A SPARE ENPOWER CABLE (LOT UNKNOWN), THE COIL STILL DID NOT DETACH. THE GREEN SYSTEM READY LIGHT AND THE DETACHMENT LIGHT HAD ILLUMINATED. THE PHYSICIAN RETRIEVED THE COIL AND USED A SPARE COIL (CATALOG/LOT UNKNOWN), WHICH DETACHED SUCCESSFULLY USING THE SAME ENPOWER CABLE (LOT UNKNOWN). THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE PROCEDURE WAS BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION AT GASTRIC VEIN. THE PATIENT WAS A MALE OF UNKNOWN AGE; WHOSE VESSELS WERE NOT CALCIFIED AND THE LEVEL OF VESSEL TORTUOUSNESS WAS UNKNOWN. 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 TIMES. NO VISIBLE DEFECT OR DAMAGE WAS NOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5932662 ↗