DELTAPAQ DFS100306-20Recalls & reported problems
Medos International Sàrl · DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 3mm x 6cm 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 00878528007692), received between Nov 1, 2016 and Nov 1, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance” (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
- Physical Resistance1
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 1, 2016Physical Resistance; Physical Resistance
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING BASILAR ARTERY ANEURYSM COILING, A DELTAPAQ (DFS10030620/S00016) COULD NOT ADVANCE THROUGH THE ECHELON 10 MICROCATHETER. IT WAS REPORTED THAT THIS WAS THE 6TH COIL USED IN THE PROCEDURE. THE COIL WOULD NOT ADVANCE INTO THE MICROCATHETER MORE THAN A FEW INCHES. THE DELTAPAQ WAS WITHDRAWN AND THE MICROCATHETER WAS FLUSHED AND A GUIDEWIRE WAS INTRODUCED TO CLEAR THE LUMEN. WHEN THE COIL WAS AGAIN ATTEMPTED TO BE LOADED INTO THE MICROCATHETER, IT WOULD NOT ADVANCE. A NEW ECHELON 10 WAS PLACED, AND 4 MORE DELTAPAQ COILS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEATH, SERIOUS INJURY OR ADDITIONAL INTERVENTIONS REQUIRED. THE DEVICES WERE USED AS PER THE IFU AND A CONTINUOUS FLUSH HAD BEEN USED WITH THE MICROCATHETER. NEITHER THE MICROCATHETER NOR THE DELTAPAQ HAD APPEARED DAMAGED DURING THE PROCEDURE (I.E. KINKED, STRETCHED, SEPARATED, DETACHED). THERE WAS NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS FINE POST-OP AND WAS DISCHARGED FROM THE HOSPITAL
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6068888 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- 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
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page