2D Helical - 35 M0013725050Recalls & 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 08714729237242), received between Aug 5, 2021 and Aug 5, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
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.
MalfunctionAug 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT COIL FAILED TO ADVANCE INSIDE CATHETER. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN AN ARTERY IN THE LIVER. A 35 5 MM X 50 MM 2D HELICAL - 35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE COULD NOT BE DELIVERED INTO THE ANGIOGRAPHY CATHETER NORMALLY AND SMOOTHLY. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT FIBER BUNDLES WERE INCOMPLETE AND APEX ZAP TIP WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12285578 ↗
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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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