2D Helical - 35 M0013724030Recalls & 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 08714729237228), received between Feb 11, 2020 and Feb 11, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
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 11, 2020Entrapment of Device; Entrapment of Device
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07FEB2020. IT WAS REPORTED THAT COIL THE WAS STUCK. THE TARGET LESION WAS LOCATED IN A BLOOD VESSEL. A 4MM X 30MM 2D HELICAL-35 WAS SELECTED FOR AN EMERGENCY HEMORRHAGE EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, AN ANGIOGRAPHY CATHETER WAS USED TO ADVANCED THE COIL. SUBSEQUENTLY, THE DEVICE COULD NOT BE PUSHED AND THE GOT COIL STUCK IN THE CONNECTION PART OF THE TIP OF THE ANGIOCATHETER. THE DEVICE WAS REMOVED WITH THE CATHETER FROM THE PATENT'S BODY WITHOUT ANY INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9694285 ↗
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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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