VortX™ - 35 M0013733060Recalls & reported problems
Boston Scientific Corporation · VORTX 35 FIBERED COIL 3MM-6MM (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 08714729237297), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2024Break; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Break; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT COIL BREAK OCCURRED. THE PATIENT UNDERWENT AN EMBOLIZATION WHERE THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS VARICOCELE. A 3MM/6MM VORTX-35 COIL WAS USED FOR THIS TREATMENT AND WAS ADVANCED ALL THE WAY INTO THE CATHETER. DURING PROCEDURE, THE SECOND PUSHABLE COIL CAME OUT STRAIGHT AND RIGID, IT DID NOT LOOP. BOTH ENDS OF THE COIL WERE DETACHED. THE DETACHED PORTION WAS NOT REMOVED BUT REMAINED IMPLANTED. THE PROCEDURE WAS COMPLETED USING AN EMBOLIC GLUE. NO COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18865120 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page