TRUPUSH 632-774XRecalls & reported problems
Cerenovus, Inc. · TRUPUSH Coil Pusher 50 cm Coil Push Diameter .017 Inches (0.43 mm) Usable Length 195 cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704029168), received between Oct 18, 2017 and Jan 5, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (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
- Material Frayed1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2018Material Frayed; Material Frayed
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, A TRUFILL COIL PUSHER ((B)(4)) BECAME FRAYED 20 CENTIMETERS (CM) FROM THE TIP AND COULD NO LONGER BE USED. THE PRODUCT WAS SUBSEQUENTLY REPLACED WITH A COMPETITOR PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS OBSERVED PRIOR TO THE EVENT. THE PRODUCT WAS RETURNED FOR ANALYSIS. PROCEDURAL AND PATIENT DETAILS ARE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7170190 ↗MalfunctionOct 18, 2017Material Separation; Material Separation
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A TRUFILL COIL PUSHER (632-774X/10764494) WAS USED DURING A PROCEDURE WHEN THE PTFE SLEEVE SHEARED OFF OF THE COIL PUSHER WHILE INSIDE THE PATIENT. THERE WAS NO DAMAGE NOTED TO THE DEVICES PRIOR TO USE. THERE WERE NO ADVERSE EVENTS TO THE PATIENT AS A RESULT OF THIS EVENT AND THERE WAS NO DELAY IN PROCEDURE. THE PATIENT'S INFORMATION IS NOT AVAILABLE. THE DEVICE IS BEING RETURNED FOR EVALUATION. REPORTEDLY, THE PATIENT IS CURRENTLY DOING FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6957644 ↗
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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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