FENIX FXS-[17]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 00855106005509), received between Feb 16, 2018 and Feb 16, 2018 — 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
- Incontinence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2018Adverse 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 INCONTINENCE (LOSS OF DEVICE EFFECTIVITY) 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 BY DR. (B)(4). DEVICE EXPLANT ON (B)(6) 2017 DUE TO LACK OF DEVICE EFFECTIVITY BY DR. (B)(4). A "LAPAROSCOPIC ABDOMINOPERINEAL RESECTION WITH END DESCENDING COLOSTOMY" AND "OMENTAL PEDICLE FLAP IN PELVIS" WERE PERFORMED AT THE TIME OF EXPLANT.
Patient problems: Incontinence
MAUDE report 7277915 ↗
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-[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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