2D Helical - 35 M0013729060Recalls & reported problems
Boston Scientific Corporation · Fibered Platinum Coil · Class 2 · Implant
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 08714729237266), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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
- Material Protrusion/Extrusion1
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.
MalfunctionFeb 27, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE LEFT RENAL ARTERY. A 9 MM X 60 MM 2D HELICAL - 35 COIL WAS SELECTED FOR USE IN A LEFT RENAL ARTERY EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS STUCK HALF IN AND HALF OUT OF THE VERY END. INTERMITTENT FLUSH WAS USED. THE CATHETER WAS REMOVED WITH THE COIL INSIDE AND REPLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME COIL DEVICE TO SUCCESSFULLY EMBOLIZE THE VESSEL. NO PATIENT COMPLICATIONS REPORTED AND PATIENT WAS GOOD POST PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9763814 ↗
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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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