STRATAFIX SXMP1B450Recalls & reported problems
Ethicon, LLC · Knotless Tissue Control Device, Dyed Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant
All models of STRATAFIX (181)
Data updated Oct 16, 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 10705031470019), received between Oct 21, 2025 and Oct 21, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- Failure to Anastomose1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNCOMPLICATED ESOPHAGECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE ANASTOMOSIS WAS PERFORMED USING A STAPLED POSTERIOR WALL AND A HAND-SEWN CLOSURE OF THE ANTERIOR COMMON ENTEROTOMY, SECURED WITH THIS RUNNING BARBED SUTURE. THREE WEEKS POST-SURGERY, THE PATIENT PRESENTED WITH AN ASYMPTOMATIC LEAK, OBSERVED ON FOLLOW UP ESOPHAGRAM. THE PATIENT CAME BACK FOR ENDOSCOPY AND ESOPHAGEAL STENTING WHICH REVEALED LOOSE BARBED SUTURES, LIKELY CONTRIBUTING TO THE ANASTOMOTIC LEAK. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Failure to Anastomose
MAUDE report 23347272 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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