FENIX FXS-[15]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 00855106005486), received between Oct 20, 2017 and Oct 20, 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
- Constipation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 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 EXPERIENCED OBSTRUCTIVE SYMPTOMS AND CONSTIPATION 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. PATIENT DISCUSSED SYMPTOMS WITH PHYSICIAN ON (B)(6) 2017 AND DID NOT WISH TO CONTINUE TO USE LAXATIVES TO FACILITATE BOWEL MOVEMENTS. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017 DUE TO OBSTRUCTIVE SYMPTOMS AND CONSTIPATION; THE DEVICE WAS REMOVED THROUGH THE ORIGINAL INCISION. THE DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL.
Patient problems: Constipation
MAUDE report 6965160 ↗
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-[17]Torax Medical, Inc. · Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)1 report
- FENIX FXS-[16]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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