STRATAFIX SXPP1B421Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031235922), received between Sep 11, 2018 and Oct 10, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 7:2AM, THE PARTURIENT UNDERWENT SURGERY AND SUFFERED A 1 ° PERINEAL LACERATION. DURING THE PROCESS OF SUTURING THE WOUND BY THE MIDWIFE, THE TAIL OF THE SUTURE NEEDLE BROKE AND WAS IMMEDIATELY REPLACED WITH A NEW ONE FOR RE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266466 ↗
• MalfunctionOct 14, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THE WOUND IS A BIT LOOSEN AFTER PASSING THROUGH THE TISSUE AND PULLING THE SUTURE COMPARING TO PREVIOUS EXPERIENCE AND OPINED THAT THE BARB DIDN'T ANCHOR THE TISSUE WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608107 ↗
• MalfunctionOct 14, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THE WOUND IS A BIT LOOSEN AFTER PASSING THROUGH THE TISSUE AND PULLING THE SUTURE COMPARING TO PREVIOUS EXPERIENCE AND OPINED THAT THE BARB DIDN'T ANCHOR THE TISSUE WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608052 ↗
• MalfunctionOct 14, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THE WOUND IS A BIT LOOSEN AFTER PASSING THROUGH THE TISSUE AND PULLING THE SUTURE COMPARING TO PREVIOUS EXPERIENCE AND OPINED THAT THE BARB DIDN'T ANCHOR THE TISSUE WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608049 ↗
• MalfunctionOct 14, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THE WOUND IS A BIT LOOSEN AFTER PASSING THROUGH THE TISSUE AND PULLING THE SUTURE COMPARING TO PREVIOUS EXPERIENCE AND OPINED THAT THE BARB DIDN'T ANCHOR THE TISSUE WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608042 ↗
• MalfunctionDec 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE BROKE OFF THE NEEDLE AT THE START OF SUTURING. THE PROCEDURE WAS DELAYED BY 2 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975748 ↗
• MalfunctionDec 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE BROKE OFF THE NEEDLE AT THE START OF SUTURING. THE PROCEDURE WAS DELAYED BY 2 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975723 ↗
• MalfunctionNov 8, 2018Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN WOUND CLOSURE PROCEDURE IN 2018 AND A SUTURE WAS USED. DURING SURGERY, WHEN THE SURGEON PUT HIS FINGERS ON EITHER SIDE OF THE INCISION AND APPLIED A LITTLE PRESSURE, THE TISSUE FELL APART AND THE SUTURE BROKE. IT WAS NOTICED THAT THERE WERE NO BARBS INTERMITTENTLY ALONG THE SUTURE. THE PROCEDURE WAS COMPLETED BY USING A REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8050582 ↗
• MalfunctionSep 11, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRAMM FLAP PROCEDURE ON (B)(6) 2018 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE BARBS WERE AT VERY LOW PROFILE AND THE SUTURE WAS WITH A MONOFILAMENT SUTURE HAND FEELING. DURING SUTURING, THE SURGEON FOUND THAT THE ANCHORS COULD NOT SECURE THE SUTURE FIRMLY WITH THE TISSUE THEREFORE THE SUTURE COULD BE PULLED BACKWARD EXTREMELY EASILY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7864634 ↗
• MalfunctionSep 11, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRAMM FLAP PROCEDURE ON (B)(6) 2018 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE BARBS WERE AT VERY LOW PROFILE AND THE SUTURE WAS WITH A MONOFILAMENT SUTURE HAND FEELING. DURING SUTURING, THE SURGEON FOUND THAT THE ANCHORS COULD NOT SECURE THE SUTURE FIRMLY WITH THE TISSUE THEREFORE THE SUTURE COULD BE PULLED BACKWARD EXTREMELY EASILY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7864624 ↗
• MalfunctionSep 11, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRAMM FLAP PROCEDURE ON (B)(6) 2018 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE BARBS WERE AT VERY LOW PROFILE AND THE SUTURE WAS WITH A MONOFILAMENT SUTURE HAND FEELING. DURING SUTURING, THE SURGEON FOUND THAT THE ANCHORS COULD NOT SECURE THE SUTURE FIRMLY WITH THE TISSUE THEREFORE THE SUTURE COULD BE PULLED BACKWARD EXTREMELY EASILY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7864617 ↗