Complex Helical - 18 M0013120770Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729324096), received between Aug 28, 2025 and Aug 28, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Advance” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Failure to Advance2
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2025Failure to Advance; Separation Failure; Failure to Advance; Separation Failure
IT WAS REPORTED THAT THE COIL COULD NOT BE DEPLOYED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT WAS PRESENTED WITH BLEEDING STOMACH. THE TARGET LESION WAS SEVERELY TORTUOUS. TWO 11MM/17MM COMPLEX HELICAL - 18 COIL WERE SELECTED FOR USE. DURING THE PROCEDURE, WHEN APPROACHING THE AREA OF THE LESION, THE TAIL END GOT STUCK AND THE COIL COULD NOT BE DEPLOYED INSIDE THE BODY, THE COIL STAYS IN THE PATIENT AFTER THE CATHETER WAS REMOVED, AND THE SNARE WAS USED TO REMOVE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE FAILURE APPEARS THE SAME WAY IN BOTH COIL DEPLOYMENTS AND BOTH COILS WERE NEEDED TO BE SNARED TO BE ABLE TO BE REMOVED FROM THE PATIENT, THE PROCEDURE WAS COMPLETED WITH COILS AND GLUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22916283 ↗InjuryAug 28, 2025Failure to Advance; Separation Failure; Failure to Advance; Separation Failure
IT WAS REPORTED THAT THE COIL COULD NOT BE DEPLOYED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT WAS PRESENTED WITH BLEEDING STOMACH. THE TARGET LESION WAS SEVERELY TORTUOUS. TWO 11MM/17MM COMPLEX HELICAL - 18 COIL WERE SELECTED FOR USE. DURING THE PROCEDURE, WHEN APPROACHING THE AREA OF THE LESION, THE TAIL END GOT STUCK AND THE COIL COULD NOT BE DEPLOYED INSIDE THE BODY, THE COIL STAYED IN THE PATIENT AFTER THE CATHETER WAS REMOVED, AND THE SNARE WAS USED TO REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE FAILURE APPEARS THE SAME WAY IN BOTH COIL DEPLOYMENTS AND BOTH COILS WERE NEEDED TO BE SNARED TO BE ABLE TO BE REMOVED FROM THE PATIENT, THE PROCEDURE WAS COMPLETED WITH COILS AND GLUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22914394 ↗
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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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