ZelanteDVT™ ClotHunter™ 114690-001Recalls & reported problems
Boston Scientific Corporation · Helical Rotation Device · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729968740), received between Nov 10, 2021 and Nov 10, 2021 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Arrest1
- Chest Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT CARDIAC ARREST AND DEATH OCCURRED. THE PATIENT WAS UNDERGOING TREATMENT FOR DEEP VEIN THROMBOSIS. HEPARIN WAS INFUSED PRIOR TO THE CASE. A ZELANTEDVT CLOTHUNTER HELICAL ROTATION DEVICE AND ZELANTEDVT CATHETER WERE SELECTED FOR USE. AFTER POWER PULSE WAS PERFORMED, THE CLOTHUNTER WAS INSERTED AND RUN PROXIMAL TO DISTAL THROUGH THE TREATMENT AREA. THE CLOTHUNTER WAS THEN ADVANCED FOR A SECOND RUN THROUGH THE TREATMENT AREA WHEN THE PATIENT EXPERIENCED CHEST PAIN AND BECAME UNRESPONSIVE. THE PATIENT EXPERIENCED A CARDIAC ARREST AND ULTIMATELY PASSED AWAY.
Patient problems: Cardiac Arrest; Chest Pain
MAUDE report 12791339 ↗
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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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