DELTAPAQ DFS100510-20Recalls & reported problems
Medos International Sàrl · DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 5mm 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
- 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 00878528007791), received between Jun 8, 2017 and Jun 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning 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
- Positioning 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.
MalfunctionJun 8, 2017Positioning Failure; Positioning Failure
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTRACRANIAL ANEURYSM COILING PROCEDURE THE PHYSICIAN HAD DIFFICULTY DETACHING A DELTAPAQ 5MM X 10 CM (DFS10051020/C27177) COIL USING AN ENPOWER DETACHMENT CONTROL BOX (DCB00000500/F75871) AND CODMAN CONNECTING CABLE (CCB00015700/S12885). REPORTEDLY THE DELTAPAQ COIL FAILED TO DETACH FOUR TIMES WHEN BEING USED WITH THE ENPOWER DETACHMENT CONTROL BOX. THE SIGNAL DIODE AND THE SOUND INDICATED THAT THE COIL DETACHED HOWEVER USING FLUOROSCOPY THE PHYSICIAN CONCLUDED THAT THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. AFTER THE FOUR ATTEMPTS TO DETACH THE COIL, THE ENPOWER DCB BOX AND THE CODMAN CABLE WERE EXCHANGED FOR ANOTHER BOX AND CABLE. THE COIL DETACHED AFTER THREE-FOUR ATTEMPTS WITH THE NEW ENPOWER DCB BOX AND CABLE. IT WAS REPORTED THAT THE POSITION OF THE IMPLANTED COIL WAS SATISFACTORY; NO HARM WAS DONE TO THE PATIENT, MRS 0. THE PROCEDURE WAS FOR TREATMENT OF UNRUPTURED LEFT MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, VESSELS WERE DIFFUSE ATHEROSCLEROTIC. REPORTEDLY THE (B)(6)-YEAR-OLD FEMALE PATIENT WAS PREVIOUSLY TREATED IN 2016 FOR A RUPTURED RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM. THERE WERE NO DAMAGES NOTED TO THE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6621880 ↗
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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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