CERECYTE PRESIDIO PC4180830-30Recalls & reported problems
Medos International Sàrl · PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 8mm x 30cm 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 00878528003205), received between Oct 14, 2016 and Oct 14, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Stretched” (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
- 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 14, 2016Stretched; Stretched
THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION, THE PRESIDIO COIL (PC418083030/C23952) STRETCHED. THE COIL WAS WITHDRAWN AND A NEW ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. AT THE TIME OF INITIAL CONTACT THE DEVICE WAS AVAILABLE FOR RETURN. THERE WAS NO REPORTED SIGNIFICANT CLINICAL DELAY TO THE PROCEDURE AS A RESULT OF THE ISSUE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THERE WERE NO KINKS IN THE MICROCATHETER. RESISTANCE WAS NOT REPORTED WHEN THE COIL WAS ADVANCED, REPOSITIONED, OR WITHDRAWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6031362 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page