FENIX FXS-[16]Recalls & reported problems
Torax Medical, Inc. · Class f · Implant
Data updated Oct 18, 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 00855106005493), received between Aug 17, 2017 and Aug 17, 2017 — classified as 1 injury.
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
- Erosion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT WAS FOUND TO HAVE FENIX BEADS ERODED THROUGH THE ANAL CANAL LEADING TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. UNEVENTFUL SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2017; 3-4 VESSELS WERE STITCHED DURING THE IMPLANT PROCEDURE TO DECREASE BLEEDING. THE PATIENT PRESENTED WITH DISCHARGE AND TENDERNESS; DURING A DIGITAL RECTAL EXAM THE DEVICE WAS FOUND TO HAVE ERODED INTO THE ANTERIOR RECTUM ON (B)(6) 2017. SYMPTOMS BEGAN (B)(6) 2017. UNEVENTFUL DEVICE EXPLANT (B)(6) 2017 DUE TO 2 FENIX DEVICE BEADS FOUND ERODED THROUGH THE ANAL CANAL; AN INFECTION WAS PRESENT AT THE EXPOSURE SITE. THE FENIX DEVICE WAS REMOVED TRANSANALLY. THE DEVICE WAS INTACT AT THE TIME OF EXPLANT. THE PATIENT WAS REPORTED AS DOING WELL AFTER REMOVAL.
Patient problems: Erosion
MAUDE report 6802365 ↗
Other Mechanical Compression Device Fecal Incontinence (Non-Manually Operated) devices
- FENIX FXS-[19]Torax Medical, Inc. · Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)2 reports
- FENIX FXS-[15]Torax Medical, Inc. · Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)1 report
- FENIX FXS-[17]Torax Medical, Inc. · Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)1 report
- FENIX FXS-[20]Torax Medical, Inc. · Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)1 report
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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