ULTIPAQ FSR100254-20Recalls & reported problems
Medos International Sàrl · ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2.5mm x 4cm 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 00878528001577), received between Dec 17, 2018 and Dec 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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
- Separation Failure1
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.
MalfunctionDec 17, 2018Separation Failure; Separation Failure
AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 2.5MM X 4CM ULTIPAQ 10 SR (FSR10025420/ L13863) THERMO-MECHANICAL COIL FAILED TO DETACH DESPITE MULTIPLE ATTEMPTS. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCT WAS DISCARDED AND IS THUS NOT AVAILABLE FOR EVALUATION. A COMPANY REPRESENTATIVE WAS NOT PRESENT DURING THE CASE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8171223 ↗
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- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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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