TRUFILL DCS ORBIT 637HF0206Recalls & reported problems
Cerenovus, Inc. · TRUFILL DCS ORBIT Detachable Coil 175cm 2mm x 6cm Coil Type: Helical Fill · 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 10886704029670), received between Jun 2, 2017 and Jun 2, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2017Positioning Failure; Positioning Failure
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION, THE ORBIT HELICAL FILL COIL (637HF0206/17360454) COULD NOT BE DETACHED. THEY WITHDREW THE COIL AND USED A NEW COIL TO COMPLETE THE PROCEDURE USING THE SAME UNSPECIFIED SYRINGE. PRIOR TO ATTEMPT TO DETACH, IT WAS VERIFIED UNDER FLUORO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR DELIVERY TUBE. NEITHER THE COIL NOR THE DELIVERY SYSTEM APPEARED DAMAGED DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS; HOWEVER, THE SYRINGE WAS DISCARDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6607438 ↗
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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