STRATAFIX SXPP2B419Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031464780), received between Sep 5, 2024 and Sep 23, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that a patient underwent an Orthopedic procedure on (b)(6)2026 and barbed suture was used. During surgery, the suture was broken during use. It was not a control release needle. Another product was used to complete the case. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871280 ↗
• MalfunctionJun 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN THE PRODUCT WAS USED. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447682 ↗
• MalfunctionJan 13, 2026Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE IN THE CATH LAB ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A PROCEDURE IN THE CATH LAB, THEY WERE USING A THE BARBED SUTURE AND MY CUSTOMER REPORTED THAT THE BARBS ON THESE SUTURES ASSOCIATED WITH THIS SPECIFIC LOT #'S WERE NOT PROMINENT AND AND NOT CATCHING/SITTING IN THE INCISION AS NEEDED. QUOTE FROM CUSTOMER" WHEN I TRIED TO PULL THE SUTURE TIGHT, IT WOULD SLIDE RIGHT OUT OR BREAK, IT WAS AS IF THIS LOT WAS MISSING BARBS. THERE WERE NO PATIENT CONSEQUENCES AND NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052170 ↗
• MalfunctionJan 13, 2026Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE IN THE CATH LAB ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A PROCEDURE IN THE CATH LAB, THEY WERE USING A THE BARBED SUTURE AND MY CUSTOMER REPORTED THAT THE BARBS ON THESE SUTURES ASSOCIATED WITH THIS SPECIFIC LOT #'S WERE NOT PROMINENT AND NOT CATCHING/SITTING IN THE INCISION AS NEEDED. QUOTE FROM CUSTOMER" WHEN I TRIED TO PULL THE SUTURE TIGHT, IT WOULD SLIDE RIGHT OUT OR BREAK, IT WAS AS IF THIS LOT WAS MISSING BARBS. THERE WERE NO PATIENT CONSEQUENCES AND NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052167 ↗
• MalfunctionJan 13, 2026Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE IN THE CATH LAB ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A PROCEDURE IN THE CATH LAB, THEY WERE USING A THE BARBED SUTURE AND MY CUSTOMER REPORTED THAT THE BARBS ON THESE SUTURES ASSOCIATED WITH THIS SPECIFIC LOT #'S WERE NOT PROMINENT AND NOT CATCHING/SITTING IN THE INCISION AS NEEDED. QUOTE FROM CUSTOMER" WHEN I TRIED TO PULL THE SUTURE TIGHT, IT WOULD SLIDE RIGHT OUT OR BREAK, IT WAS AS IF THIS LOT WAS MISSING BARBS. THERE WERE NO PATIENT CONSEQUENCES AND NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052165 ↗
• MalfunctionJan 13, 2026Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE IN THE CATH LAB ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A PROCEDURE IN THE CATH LAB, THEY WERE USING A THE BARBED SUTURE AND MY CUSTOMER REPORTED THAT THE BARBS ON THESE SUTURES ASSOCIATED WITH THIS SPECIFIC LOT #'S WERE NOT PROMINENT AND AND NOT CATCHING/SITTING IN THE INCISION AS NEEDED. QUOTE FROM CUSTOMER" WHEN I TRIED TO PULL THE SUTURE TIGHT, IT WOULD SLIDE RIGHT OUT OR BREAK, IT WAS AS IF THIS LOT WAS MISSING BARBS. THERE WERE NO PATIENT CONSEQUENCES AND NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052164 ↗
• MalfunctionJan 13, 2026Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE IN THE CATH LAB ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A PROCEDURE IN THE CATH LAB, THEY WERE USING A THE BARBED SUTURE AND MY CUSTOMER REPORTED THAT THE BARBS ON THESE SUTURES ASSOCIATED WITH THIS SPECIFIC LOT #'S WERE NOT PROMINENT AND NOT CATCHING/SITTING IN THE INCISION AS NEEDED. QUOTE FROM CUSTOMER" WHEN I TRIED TO PULL THE SUTURE TIGHT, IT WOULD SLIDE RIGHT OUT OR BREAK, IT WAS AS IF THIS LOT WAS MISSING BARBS. THERE WERE NO PATIENT CONSEQUENCES AND NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052163 ↗
• MalfunctionDec 12, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE BARB HOOKING WAS BAD. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919897 ↗
• MalfunctionSep 5, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, IT COULD NOT BE USED BECAUSE IT WAS NOT HOOKED. ANOTHER PACKAGE COULD USE WITHOUT PROBLEM. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146531 ↗