CERECYTE PRESIDIO PC4181750-30Recalls & reported problems
Medos International Sàrl · PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 17mm x 50cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of CERECYTE PRESIDIO (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528003298), received between Oct 25, 2017 and Oct 25, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Kinked” (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
Device problems
- Kinked1
- Physical Resistance1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2017Kinked; Stretched; Physical Resistance; Kinked; Stretched; Physical Resistance
AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PRESIDIO 18 COIL (PC4181750-30, 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 (PC418164730/ 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 T
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6977802 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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