ULTIPAQ FSR100208-20Recalls & reported problems
Medos International Sàrl · ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2mm x 8cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
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 00878528001553), received between Oct 13, 2017 and Oct 13, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance” (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
- 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 13, 2017Stretched; Physical Resistance; Stretched; Physical Resistance
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION AT AN UNKNOWN LOCATION, AN ULTIPAQ COIL (FSR10020820/ S10351) COULD NOT BE PLACED INTO THE ENTRANCE OF AN UNSPECIFIED CATHETER AND DURING PRODUCT ANALYSIS, IT WAS DETERMINED THAT THE COIL WAS STRETCHED. THE SAME TYPE COIL ADVANCED THROUGH THE SAME CATHETER AFTERWARD. THERE WAS NO POTENTIAL ADVERSE EVENT TO THE PATIENT AND THE PROCEDURE WAS DELAY 5 MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6947548 ↗
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- 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.
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