STRATAFIX SXPP1B420Recalls & reported problems

Summary

The FDA's MAUDE database contains 229 adverse event reports that list this exact device (DI 10705031235809), received between Nov 20, 2017 and Jul 9, 2026 — classified as 1 death, 24 injuries, 204 malfunctions.

The most frequently reported specific device problem is “Break” (111 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 25 most recent of 229 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762763 ↗
• MalfunctionJul 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762762 ↗
• MalfunctionJul 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762761 ↗
• MalfunctionJul 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762760 ↗
• MalfunctionJul 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762759 ↗
• MalfunctionJul 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762729 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429366 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLOSTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING A ROBOTIC COLOSTOMY REVERSAL PROCEDURE, BOTH SUTURES BROKE AND FRACTURED, REQUIRING THE PROCEDURE TO BE RESTARTED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171873 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLOSTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING A ROBOTIC COLOSTOMY REVERSAL PROCEDURE, BOTH SUTURES BROKE AND FRACTURED, REQUIRING THE PROCEDURE TO BE RESTARTED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171509 ↗
• MalfunctionApr 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE LAPAROSCOPIC PROCEDURE, WHILE THE DOCTOR IS PASSING STITCHES IN THE PERITONEUM AND PULLING TO COPE, THE NEEDLE JUMPS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035387 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER'S STITCHES BROKE WHILE USING OUR PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028100 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DISTAL GASTRECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A ROBOT-ASSISTED DISTAL GASTRECTOMY, THE DOCTOR NOTICED AN ABNORMALITY IN THE LOOP SHAPE THE SUTURE AT THE PROXIMAL END DURING USE AND USE WAS STOPPED. IT COULD CONFIRM THAT THE SUTURE WAS BROKEN ABOUT 3 CENTIMETERS FROM THE LOOP, BUT IT COULDN'T VISUALLY DETECT ANY ABNORMALITY IN THE LOOP SHAPE WHEN THE SALES REP CHECKED THE PRODUCT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.4. PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821358 ↗
• MalfunctionApr 3, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. WHEN USING THE BARBED THREAD FOR A BY PASS, THE SURGEON REALIZED THAT THE THREAD DID NOT HOLD. THAT IS, HE COULD REMOVE IT VERY EASILY. 5 THREADS IN A ROW. NOTCHING IS THEREFORE NOT EFFECTIVE. IMMEDIATE ACTION: REMOVING THE WIRE. IN THE END, AFTER 5 WIRES, TRANSITION TO V-LOCK. CONSEQUENCE: WASTE OF WIRE, LOSS OF TIME, BOTHERED SURGEON, POTENTIAL IMPORTANT PATIENT RISKS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775108 ↗
• MalfunctionApr 1, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. WHEN USING THE BARBED THREAD FOR A BYPASS, THE SURGEON REALIZED THAT THE THREAD DID NOT HOLD. THAT IS, HE COULD REMOVE IT VERY EASILY. 5 THREADS IN A ROW. NOTCHING IS THEREFORE NOT EFFECTIVE. IMMEDIATE ACTION: REMOVING THE WIRE. IN THE END, AFTER 5 WIRES, TRANSITION TO V-LOCK. CONSEQUENCE: WASTE OF WIRE, LOSS OF TIME, BOTHERED SURGEON, POTENTIAL IMPORTANT PATIENT RISKS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757664 ↗
• MalfunctionApr 1, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. WHEN USING THE BARBED THREAD FOR A BYPASS, THE SURGEON REALIZED THAT THE THREAD DID NOT HOLD. THAT IS, HE COULD REMOVE IT VERY EASILY. 5 THREADS IN A ROW. NOTCHING IS THEREFORE NOT EFFECTIVE. IMMEDIATE ACTION: REMOVING THE WIRE. IN THE END, AFTER 5 WIRES, TRANSITION TO V-LOCK. CONSEQUENCE: WASTE OF WIRE, LOSS OF TIME, BOTHERED SURGEON, POTENTIAL IMPORTANT PATIENT RISKS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757589 ↗
• MalfunctionApr 1, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. WHEN USING THE BARBED THREAD FOR A BYPASS, THE SURGEON REALIZED THAT THE THREAD DID NOT HOLD. THAT IS, HE COULD REMOVE IT VERY EASILY. 5 THREADS IN A ROW. NOTCHING IS THEREFORE NOT EFFECTIVE. IMMEDIATE ACTION: REMOVING THE WIRE. IN THE END, AFTER 5 WIRES, TRANSITION TO V-LOCK. CONSEQUENCE: WASTE OF WIRE, LOSS OF TIME, BOTHERED SURGEON, POTENTIAL IMPORTANT PATIENT RISKS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757582 ↗
• MalfunctionMar 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED INGUINAL HERNIA REPAIR PROCEDURE IN (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT NEEDLE DETACHED PREMATURELY DURING A ROBOTIC ASSISTED INGUINAL HERNIA REPAIR. FINISHED THE CASE WITH A SECOND IDENTICAL DEVICE. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706460 ↗
• MalfunctionMar 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CUT FROM SWAGE AREA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24667538 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN GASTRIC BYPASS PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. NEEDLE SEPARATED FROM THREAD DURING SURGERY. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441786 ↗
• MalfunctionFeb 25, 2026Material Separation

  "IT" WAS REPORTED A PATIENT UNDERWENT AN GASTRIC BYPASS PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. NEEDLE SEPARATED FROM THREAD DURING SURGERY. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441783 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN GASTRIC BYPASS PROCEDURE (B)(6) 2026 AND BARBED SUTURE WAS USED. NEEDLE SEPARATED FROM THREAD DURING SURGERY. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441780 ↗
• MalfunctionFeb 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI SURGICAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. SUTURE AND NEEDLE DETACHED WHEN THREADING THROUGH THE DRAPE RINGS DURING DA VINCI SURGICAL SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257526 ↗
• MalfunctionJan 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRO-JEJUNOSTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT IS FOUND THAT THE BARBED DE-ATTACHED FROM THE SWAGE AREA DURING GASTRO-JEJUNOSTOMY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190424 ↗
• MalfunctionJan 12, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY AND ENDOSCOPY COOPERATIVE SURGERY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED ON THE LESSER CURVATURE OF STOMACH. AFTER GASTRIC RESECTION, CONTINUOUS SUTURING WAS PERFORMED FROM THE CARDIAC SIDE USING THE BARBED SUTURE. AS THE SUTURING PART WAS LONG AND THE SUTURE WAS NOT ENOUGH, A SECOND CONTINUOUS SUTURING WAS PERFORMED FROM THE PYLORIC SIDE. WHEN A DRAIN WAS INSERTED, LOOSENING OF THE SUTURE WAS CONFIRMED, SO ADDITIONAL SUTURING WAS PERFORMED USING ANOTHER BARBED SUTURE. A LEAK TEST WAS DONE AND THERE WERE NO ISSUES FOUND, AND THE WOUND WAS CLOSED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24034963 ↗
• InjuryJan 12, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY AND ENDOSCOPY COOPERATIVE SURGERY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED ON THE LESSER CURVATURE OF STOMACH. AFTER GASTRIC RESECTION, CONTINUOUS SUTURING WAS PERFORMED FROM THE CARDIAC SIDE USING THE BARBED SUTURE. AS THE SUTURING PART WAS LONG AND THE SUTURE WAS NOT ENOUGH, A SECOND CONTINUOUS SUTURING WAS PERFORMED FROM THE PYLORIC SIDE. A LEAK TEST WAS DONE AND THERE WERE NO ISSUES FOUND, AND THE WOUND WAS CLOSED. POST-OP, A LEAK WAS LATER IDENTIFIED AFTER SURGERY, AND ON (B)(6) 2025, A LAVAGE WAS DONE AT AN OPEN SURGERY. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THE PATIENT HAS BEEN HOSPITALIZED. ALTHOUGH THE PATIENT IS RECOVERING, ORAL INTAKE HAS NOT YET BEEN RESUMED. THE DOCTOR BELIEVES THAT IMPROPER USING OF THE BARBED MAY HAVE CAUSED IT TO LOOSEN, LEADING TO THE LEAK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 24034936 ↗