Stratafix Spiral SXPL1B400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031228122), received between Jun 27, 2022 and Apr 10, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryApr 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A SURGICAL PROCEDURE IT WAS REPORTED THAT, WHEN THE DOCTOR PASSES THE POINT AT THE SUB-AXILLARY LEVEL; THE SUTURE WAS DAMAGED, LEAVING IT IN THE MIDDLE STRAND (STRATAFIX 2/0 SUTURE OF 30CM). THE SURGERY WAS NOT DELAYED. IT IS NOT KNOWN HOW THE FRAGMENTS WERE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19082441 ↗
• InjuryApr 28, 2023Improper or Incorrect Procedure or Method; Device Sensing Problem; Improper or Incorrect Procedure or Method; Device Sensing Problem

  THE FOLLOWING EVENT WAS REPORTED BY OUR DISTRIBUTOR: PROCEDURE/SURGERY NAME GASTRIC BYPASS. PROCEDURE/SURGERY DATE (B)(6) 2023. DESCRIBE EVENT A STRATAFIX NON-ABSORBABLE WAS USED IN GASTRIC BYPASS, ANASTOMOSIS GASTRO-ENTERO. THIS WAS A MISTAKE, BECAUSE IT SHOULD BE AN ABSORBABLE. THE USER DIDN¿T SEE NON-ABS ON THE INNER PACKAGE, AND THEREFORE THOUGHT IT WAS OK TO USE. IS THIS REPORT RELATED TO A: SINGLE USE DEVICE. IS THIS THE FIRST TIME THAT THE DEVICE WAS BEING USED? NO. WHEN DID THE DEVICE PROBLEM OCCUR? WHILE SUTURING GASTRO-ENTERO ANASTOMOSIS. WAS THE USER TRAINED? YES. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? THEY NEEDED TO CUT OUT THE WHOLE SUTURE AND PLACE A NEW ONE. HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE (MINUTES)? 30 MINUTES. NO PATIENT CONSEQUENCES. HAS THE SURGEON OR DOCTOR PROVIDED A MEDICAL RATIONALE THAT INDICATES THE USE OF THE PRODUCT IS IN NO WAY RELATED TO THE REPORTED EVENT?: HE WOULD LIKE TO SEE MORE INFO ON INNER AND OUTER PACKAGE, OR AT LEAST, THE SAME INFO ON INNER PACKAGE SO MISTAKES CAN BE AVOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829863 ↗
• MalfunctionJun 27, 2022Break

  OUR DISTRIBUTOR REPORTED THERE WAS AN ISSUE REGARDING STRATAFIX (SXPL1B400), SURGEON WAS PERFORMING IPOM AND HE IS NEWLY CONVERTED USER OF STRATAFIX FOR DEFECT CLOSURE IN VENTRAL HERNIA. DURING THE DEFECT CLOSURE THE THREAD BROKE FROM THE NEEDLE TIP AND THE NEEDLE GOT LOST IN THE ABDOMEN WHICH WAS FURTHER TAKEN OUT WITH THE HELP OF C-ARM XRAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14837458 ↗