DELTAPLUSH DPL100304-20Recalls & reported problems
Medos International Sàrl · DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 3mm x 4cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
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 00878528008118), received between Jun 5, 2018 and Jun 5, 2018 — 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 16, 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 5, 2018Positioning Failure; Positioning Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE DELTAPLUSH COIL, 10 SYS 3X4 (DLP10030420 / S10825) WAS USED; THE ENPOWER CONTROL CABLE AND THE SYSTEM TO DETACH THE COIL WAS TESTED WITH ALL THE LIGHTS ILLUMINATED. THE DELTAPLUSH COIL WAS CONNECTED BUT THE SYSTEM DID NOT SHOW A GREEN LIGHT TO DETACH THE COIL. THE COIL WAS REPLACED WITH ANOTHER DELTAPLUSH COIL (THE DELTAPLUSH COIL, 10 SYS 3X6). THE GREEN LIGHT DID NOT TURN ON; THE SYSTEM WAS TURNED OFF AND BACK ON AGAIN BEFORE THE GREEN LIGHT ILLUMINATED AND THE COIL WAS DETACHED. IT WAS CONFIRMED THAT ALL THE CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT ANY EXCESSIVE FORCE. THE SAME CONTROL CABLE AND DETACHMENT CONTROL BOX (DCB) WERE USED WITH SUBSEQUENT COILS IN THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7570031 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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