2D Helical - 35 M0013727040Recalls & reported problems
Boston Scientific Corporation · Fibered Platinum Coil · 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 08714729195597), received between Apr 1, 2020 and Apr 1, 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 16, 2026.
Most reported problems
Device problems
- Entrapment of Device1
- Fracture1
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.
MalfunctionApr 1, 2020Entrapment of Device; Fracture; Entrapment of Device; Fracture
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAR2020. IT WAS REPORTED THAT THE COIL GOT STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE PORTAL VEIN. A 7MMX40MM 2D HELICAL - 35 EMBOLIC COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE DELIVERY CATHETER. THE DEVICE WAS REMOVED AS A UNIT AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9913755 ↗
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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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