DELTAPAQ DFS100202-20Recalls & reported problems
Medos International Sàrl · DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 2cm 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
- 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 00878528007562), received between May 24, 2017 and May 24, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
- Difficult or Delayed Positioning1
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.
MalfunctionMay 24, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COILING OF A BASILAR ANEURYSM, A DELTAPAQ COIL (DFS10020220/C13011) FAILED TO DETACH USING A DETACHMENT CONTROL BOX (DCB00000500/LOT UNK) AND A CABLE (ECB00018200, LOT UNK). THE COIL WAS THE SECOND COIL USED. AFTER SUCCESSFUL POSITIONING IN THE ANEURYSM THE COIL COULD NOT BE DETACHED AFTER SEVERAL ATTEMPTS. THE COIL WAS RECOVERED WITHOUT DETACHMENT. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED AND NO FAULT LIGHT WAS SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITOUT APPLICATION OF EXCESSIVE FORCE. THE NEXT COIL COULD BE PLACED SUCCESSFULLY WITH THE SL 10 MICROCATHETER USING THE SAME DETACHMENT CONTROL BOX AND CABLE. THE CABLE AND DETACHMENT BOX WERE DISCARDED AFTER THE PROCEDURE. THERE WAS NO PATIENT HARM OR SURGICAL DELAY GREATER THAN 30 MINUTES REPORTED. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6588028 ↗
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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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