DELTAPAQ DFS100206-20Recalls & reported problems
Medos International Sàrl · DELTAPAQ microcoil DELTAPAQ 10 Stretch Resistant Coil 2mm x 6cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of DELTAPAQ (18)
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 00878528007593), received between Feb 24, 2021 and Feb 24, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2021Failure to Advance; Failure to Advance
AS REPORTED BY THE FIELD, DURING THE EMBOLIZATION PORTION OF THE PROCEDURE, A 2MMX6CM SR PLAT DELTAPAQ COIL (DFS10020620, L12665) COULD NOT ADVANCE THROUGH THE DELIVERY SYSTEM FOR DEPLOYMENT. THE RESISTANCE WAS FELT INSIDE THE SL-10 MICROCATHETER (MC). A SYNCHRO-14 WIRE AND OTHER COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE DELTAPAQ COIL DID NOT APPEAR TO BE DAMAGED AT ANY TIME. THE CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE PATIENT WAS DIAGNOSED WITH OROPHARYNGEAL SQUAMOUS CELL CARCINOMA (SCC) AND PRESENTED WITH LARGE VOLUME ORAL CAVITY HEMORRHAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11372468 ↗
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- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
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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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