VortX™ - 35 M0013733050Recalls & reported problems
Boston Scientific Corporation · VORTX 35 FIBERED COIL 3MM-5MM (1) · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729237280), received between Mar 2, 2022 and Mar 2, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
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.
InjuryMar 2, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ADDITIONAL INTERVENTION WAS REQUIRED TO RETRIEVE THE COIL. A 3MM-5MM VORTX-35 FIBERED COIL WAS SELECTED FOR USE IN A COILING PROCEDURE IN A MILDLY TORTUOUS VESSEL. WHEN THE COIL WAS DELIVERED OUT OF THE CATHETER, THE PHYSICIAN NOTICED THAT THE COIL DID NOT FORM TO ITS SHAPE BUT STAYED STRAIGHT. THE COIL WAS PULLED OUT BY USING A RETRIEVAL SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13656754 ↗
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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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