STRATAFIX SXMP1B441Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031470057), received between Feb 26, 2026 and Feb 26, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Positioning Failure; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT DURING ROBOTIC HERNIA CASES FOR THE SURGEONS, WHEN TRYING TO INSERT SUTURE SPIRAL DOWN 8MM INTUITIVE TROCAR PORT THE NEEDLE DETACHED AT THE SWAGE SITE AND FELL INTO THE PATIENT. THE NEEDLE WAS PROMPTLY LOCATED AND REMOVED FROM THE PATIENT IN MOST SITUATIONS. IN ONE INSTANCE, THE NEEDLE WAS LOST IN THE PATIENT AND REQUIRED X-RAYS TO LOCATE THE LOST NEEDLE. THERE WAS ALSO COMPLAINTS MENTIONED IN OUR DISCUSSION REGARDING THE SUTURE "SLIPPING" WHEN TRYING TO CLOSE THE PERITONEUM. THE SLIPPING WAS TYPICALLY RESOLVED THROUGH ADDITIONAL PULLING TO ENGAGE THE BARBS FURTHER, HOWEVER THE SURGEONS DID HAVE CONCERN REGARDING LONG TERM HOLD. THE DEVICES WERE NOT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461270 ↗
• MalfunctionFeb 26, 2026Positioning Failure; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT DURING ROBOTIC HERNIA CASES FOR THE SURGEONS, WHEN TRYING TO INSERT SUTURE SPIRAL DOWN 8MM INTUITIVE TROCAR PORT THE NEEDLE DETACHED AT THE SWAGE SITE AND FELL INTO THE PATIENT. THE NEEDLE WAS PROMPTLY LOCATED AND REMOVED FROM THE PATIENT IN MOST SITUATIONS. IN ONE INSTANCE, THE NEEDLE WAS LOST IN THE PATIENT AND REQUIRED X-RAYS TO LOCATE THE LOST NEEDLE. THERE WAS ALSO COMPLAINTS MENTIONED IN OUR DISCUSSION REGARDING THE SUTURE "SLIPPING" WHEN TRYING TO CLOSE THE PERITONEUM. THE SLIPPING WAS TYPICALLY RESOLVED THROUGH ADDITIONAL PULLING TO ENGAGE THE BARBS FURTHER; HOWEVER, THE SURGEONS DID HAVE CONCERN REGARDING LONG TERM HOLD. THE DEVICES WERE NOT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461267 ↗
• MalfunctionFeb 26, 2026Positioning Failure; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT DURING ROBOTIC HERNIA CASES FOR THE SURGEONS, WHEN TRYING TO INSERT SUTURE SPIRAL DOWN 8MM INTUITIVE TROCAR PORT THE NEEDLE DETACHED AT THE SWAGE SITE AND FELL INTO THE PATIENT. THE NEEDLE WAS PROMPTLY LOCATED AND REMOVED FROM THE PATIENT IN MOST SITUATIONS. IN ONE INSTANCE, THE NEEDLE WAS LOST IN THE PATIENT AND REQUIRED X-RAYS TO LOCATE THE LOST NEEDLE. THERE WAS ALSO COMPLAINTS MENTIONED IN OUR DISCUSSION REGARDING THE SUTURE "SLIPPING" WHEN TRYING TO CLOSE THE PERITONEUM. THE SLIPPING WAS TYPICALLY RESOLVED THROUGH ADDITIONAL PULLING TO ENGAGE THE BARBS FURTHER; HOWEVER, THE SURGEONS DID HAVE CONCERN REGARDING LONG TERM HOLD. THE DEVICES WERE NOT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24457417 ↗
• MalfunctionFeb 26, 2026Positioning Failure; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT DURING ROBOTIC HERNIA CASES FOR THE SURGEONS, WHEN TRYING TO INSERT SUTURE SPIRAL DOWN 8 MM INTUITIVE TROCAR PORT THE NEEDLE DETACHED AT THE SWAGE SITE AND FELL INTO THE PATIENT. THE NEEDLE WAS PROMPTLY LOCATED AND REMOVED FROM THE PATIENT IN MOST SITUATIONS. IN ONE INSTANCE, THE NEEDLE WAS LOST IN THE PATIENT AND REQUIRED X-RAYS TO LOCATE THE LOST NEEDLE. THERE WAS ALSO COMPLAINTS MENTIONED IN OUR DISCUSSION REGARDING THE SUTURE "SLIPPING" WHEN TRYING TO CLOSE THE PERITONEUM. THE SLIPPING WAS TYPICALLY RESOLVED THROUGH ADDITIONAL PULLING TO ENGAGE THE BARBS FURTHER. HOWEVER, THE SURGEONS DID HAVE CONCERN REGARDING LONG TERM HOLD. THE DEVICES WERE NOT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24457415 ↗