CERECYTE PRESIDIO PC4181846-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528003304), received between Sep 27, 2016 and Mar 28, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult To Position” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 THE PHYSICIAN TRIED TO RE-SHEATH THE COIL BUT THE SHEATH INTRODUCER SPLIT OPEN WHEN THE DELIVERY WIRE WAS WITHDRAWN AND WAS UNABLE TO RE-SHEATH THE COIL.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 6439222 ↗
• MalfunctionJan 24, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A LARGE 18.4 X 21.6MM LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM, A PRESIDIO COIL (PC418184630/C34513) COULD NOT BE DETACHED. THE PHYSICIAN WITHDREW THE COIL AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THE ENPOWER DCB AND CONNECTING CABLE WERE BOTH USED WITH SUBSEQUENT COILS DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY AND NO DELAY IN PROCEDURE. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6274297 ↗
• MalfunctionSep 27, 2016Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE WHEN INSERTING THE PRESIDIO COIL (PC418184630/C28139) INTO THE PROWLER SELECT PLUS MICROCATHETER (LOT UNKNOWN). THE COIL WAS REMOVED FROM THE CATHETER AND UNRAVELING OF THE COIL WAS VISUALLY CONFIRMED. THE COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THE PROCEDURE WAS THE COIL EMBOLIZATION OF AN ANEURYSM AT RENAL ARTERY. THE PATIENT WAS (B)(6) MALE WHOSE VESSELS WERE MILDLY TORTUROUS AND MODERATELY CALCIFIED. 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 THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT OR DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. THE PRODUCT WILL BE RETURNED FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5980380 ↗