VortX™ Diamond - 18 M0013822060Recalls & reported problems
Boston Scientific Corporation · Fibered Platinum Coil · Class 2 · Implant
Data updated Oct 18, 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 08714729201205), received between Sep 1, 2021 and Sep 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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 18, 2026.
Most reported problems
Device problems
- Entrapment of Device1
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.
MalfunctionSep 1, 2021Entrapment of Device; Entrapment of Device
REPORTABLE BASED ON DEVICE INVESTIGATION COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE SPRING COIL WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE UPPER GASTROINTESTINAL TRACT. A 6MM/6.7 MM VORTX DIAMOND - 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SPRING COIL GOT STUCK IN THE HUB OF THE CATHETER DURING DELIVERY. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE FIBER BUNDLES MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12409826 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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