VortX™ - 18 M0013812030Recalls & 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 08714729324843), received between Jan 10, 2020 and Jan 10, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
- Difficult to Open or Remove Packaging Material1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2020Contamination; Difficult to Open or Remove Packaging Material; Contamination; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT THE DEVICE BECAME UNSTERILE. A 3MM/2.5 MM VORTX - 18 WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE MOUNT WAS MISSING, AND THE PACKAGE WAS OPENED WITH FORCE. CONSEQUENTLY, THE DEVICE BOUNCED OUT OF THE PACKAGE AND BECAME UNSTERILE. THERE WAS NO ANOMALY WITH THE POUCH PRIOR TO USE AND HAS NEVER BEEN OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9575405 ↗
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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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