Lynx Ultra System M0068503060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506007676), received between Sep 4, 2025 and Dec 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A MID-URETHRAL SLING PROCEDURE USING A LYNX ULTRA SYSTEM DEVICE, THE SLING BECAME TANGLED WHILE BEING PULLED THROUGH THE ANATOMY, AND THE MESH APPEARED SHREDDED. THE PHYSICIAN NOTED THAT THE INTEGRITY OF THE MESH APPEARED COMPROMISED AND DID NOT FEEL COMFORTABLE PROCEEDING WITH IMPLANTATION, SO THE SLING WAS REMOVED, RESULTING IN A PROLONGED PROCEDURE. THE PATIENT EXPERIENCED DISSECTION AND SUPRAPUBIC EXTRUSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 15, 2025: THERE WERE NO PATIENT COMPLICATIONS. DISSECTION WAS PERFORMED, THEN THE SLING WAS PLACED, BUT THE SLING STRETCHED AND THE PHYSICIAN WASN'T HAPPY WITH IT, SO THE SLING WAS REMOVED. THE ONLY PATIENT IMPACT WAS EXTENDED THE EXTENDED PROCEDURE TIME TO PLACE A SECOND SLING.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 23792335 ↗
• MalfunctionSep 4, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING A LYNX ULTRA SYSTEM DEVICE, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH TROCAR PLACEMENT. THE RIGHT TROCAR APPEARED TO BE POSITIONED TOO CLOSE TO THE BLADDER, REQUIRING THE PHYSICIAN TO REPOSITION THE TROCARS MULTIPLE TIMES. AS A RESULT, THE MESH BECAME DISTORTED. DISSECTION WAS PARTICULARLY DIFFICULT FOR THE PATIENT, WHICH THE PHYSICIAN BELIEVES WAS A CONTRIBUTING FACTOR TO THE DIFFICULTY EXPERIENCED, ALTHOUGH THE PATIENT'S ANATOMY WAS UNREMARKABLE. A SECOND LYNX ULTRA SYSTEM DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22966920 ↗