DELTAPAQ DFS100716-20Recalls & reported problems
Medos International Sàrl · DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 7mm x 16cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of DELTAPAQ (18)
Data updated Oct 16, 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 00878528007883), received between Nov 26, 2018 and Nov 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 2026.
Most reported problems
Device problems
- Material Twisted/Bent1
- 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.
MalfunctionNov 26, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DELTAPAQ 10 STRETCH RESISTANT COIL 7MM X 16CM (DFS10071620 / P10306) WAS DEFECTIVE DURING THE PROCEDURE. THE DELTAPAQ COIL WAS REPLACED AND THE PATIENT WAS TREATED WITH THE REPLACEMENT COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8104091 ↗
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- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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