DELTAPAQ DFS100310-20Recalls & reported problems
Medos International Sàrl · DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 10cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of DELTAPAQ (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528007715), received between Oct 4, 2016 and Feb 8, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Stretched” (2 reports).
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
- Stretched2
- Difficult To Position1
- Knotted1
- Positioning Failure1
- Premature Activation1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 8, 2017Positioning Failure; Knotted; Stretched; Positioning Failure; Knotted; Stretched
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAPAQ COIL (DFS10031020/(B)(4)) WOULD NOT DETACH DESPITE SEVERAL ATTEMPTS. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6311778 ↗MalfunctionOct 4, 2016Difficult To Position; Premature Activation; Stretched; Difficult To Position; Premature Activation; Stretched
IT WAS REPORTED BY THE CONTACT AT THE USER FACILITY THAT THE SURGEON WAS PACKING THE LAST COIL A DELTAPAQ 3 X 10 CM COIL (DFS10031020/LOT UNKNOWN) THE LAST 2CM OF THE COIL WOULD NOT GO IN. THE COIL STRETCHED AND DETACHED DURING MANIPULATION. SURGEON COMPLETED THE PROCEDURE USING A COMPETITOR'S STENT TO PLASTER THE COIL TO THE WALL OF THE ARTERY. THE WIDE NECK ANEURYSM WAS OF SIZE 6MM X 4.5MM. PATIENT WAS REPORTED TO BE FINE BUT CARRYING A RISK OF CLOT FORMATION AROUND THE STENT AS THE PATIENT UNDERWENT ACUTE STENTING. PATIENT WILL CONTINUE ON ANTIPLATELET TREATMENT FOR 3 MONTHS AND ASPIRIN FOR 1 YEAR. ANEURYSM WAS REPORTED TO BE TREATED WITH NO RESIDUALS. IT WAS REPORTED THAT THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5996538 ↗
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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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