STRATAFIX SXPP1A415Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031244986), received between Oct 19, 2022 and Jun 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ROBOTIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE REP WHO WAS IN THE CASE THAT WHILE SUTURING THE SUTURE SPLIT BUT DID NOT DETACH FROM THE NEEDLE AT THE SWEDGE. THIS HAPPENED WITH TWO DIFFERENT SUTURE CODES DURING THE CASE. SAME SUTURES WERE USED TO CONTINUE WITH THE PROCEDURE. NO PRODUCT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134123 ↗
• MalfunctionOct 19, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE IN 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BARBS ARE PULLING RIGHT THROUGH AND NOT CATCHING IN THE TISSUE. A VLOC WAS USED TO CLOSE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633892 ↗
• MalfunctionOct 19, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE IN 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BARBS ARE PULLING RIGHT THROUGH AND NOT CATCHING IN THE TISSUE. A VLOC WAS USED TO CLOSE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633821 ↗