CERECYTE PRESIDIO PC4181137-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528003236), received between Sep 20, 2016 and Dec 6, 2021 — 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.

• MalfunctionDec 6, 2021Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED EMBOLIZATION OF THE RIGHT INTERNAL CAROTID ARTERY, A COMPETITOR¿S MICROCATHETER (MC) WAS AT TARGET POSITION. A PRESIDIO 18 CERE 11MMX37CM COIL (PC418113730, 30399458) WAS DELIVERED TO THE MICROCATHETER AND PARTIALLY ARRIVED AT ANEURYSM. THE PHYSICIAN TRIED TO RETRACT THE COIL ¿A LITTLE¿ FOR ADJUSTING ITS POSITION, BUT FELT RESISTANCE. THE PHYSICIAN THEN DECIDED TO CONTINUE TO FILL THE ANEURYSM WITH THE REMAINING COIL, HOWEVER, THE COIL WAS DIFFICULT TO ADVANCE ANYMORE. AFTER SEVERAL ATTEMPTS, THE COIL ¿BROKE¿, ONE PART OF THE COIL THAT WAS ORIGINALLY INSIDE THE ANEURYSM REMAINED WHILE THE OTHER PART OF THE COIL OUTSIDE THE ANEURYSM WAS REMOVED. THE PHYSICIAN FILLED THE ANEURYSM WITH ANOTHER COIL AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORT. RETURNED MEDICAL IMAGING WAS REVIEWED BY A NEUROINTERVENTIONALIST. THE ASSESSMENT READS AS FOLLOWS: "THE EVENT DESCRIPTION PROVIDED BY THE PHYSICIAN INDICATES THE COIL DID NOT RESPOND WHICH CAN BE DUE TO PREMATURE DETACHMENT OR COIL STRETCHING. THE CONDITIONS OF PREMATURE DETACHMENT OR COIL STRETCHING ARE DESCRIBED IN LITERATURE AND KNOWN TO OCCUR IN = 2,5% OF CASES AND ARE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932811 ↗
• MalfunctionAug 25, 2017Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PRESIDIO 18 COIL (B)(4) COULD NOT BE DETACHED DURING THE PROCEDURE. THEY USED ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819878 ↗
• 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 6646136 ↗
• MalfunctionSep 20, 2016Difficult or Delayed Positioning; Stretched; Difficult or Delayed Positioning; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE RENAL ARTERY A PRESIDIO 18 COIL (PC418113730/ C28745) UNRAVELED. PATIENT WAS A (B)(6) FEMALE WHOSE VESSELS WERE HEAVILY TORTUROUS AND MILDLY CALCIFIED. IT WAS REPORTED THAT THE PRESIDIO COIL UNRAVELED WHEN THE WIRE WAS HANDLED AROUND Y CONNECTOR, THE COIL ALSO PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER (COMPETITOR'S DEVICE). THE COIL WAS SAFELY REMOVED FROM THE PATIENT ALONG WITH THE MICROCATHETER AND REPLACED WITH ANOTHER COIL (SAME SIZE, ANOTHER PRODUCT). THE PROCEDURE WAS 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 OR 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 PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5962950 ↗