Versipass Suture Passer Needle 4727Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860794002679), received between Apr 23, 2026 and Jun 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 8, 2026Material Fragmentation

  THE COMPLAINT WAS REPORTED FROM STRYKER INVOLVING THE VERSIPASS NEEDLE MANUFACTURED BY LINCOTEK MEDICAL LLC. THE EVENT TOOK PLACE IN THE UNITED STATES. DURING A SURGICAL PROCEDURE ON (B)(6) 2026, TWO VERSIPASS NEEDLES FRACTURED DURING USE. THE FIRST NEEDLE FRACTURED APPROXIMATELY HALFWAY DOWN THE SHAFT DURING DEPLOYMENT. A SECOND NEEDLE WAS SUBSEQUENTLY OPENED AND USED; HOWEVER, THIS NEEDLE FRACTURED AT THE DISTAL TIP IN TWO LOCATIONS RESULTING IN BROKEN NEEDLE FRAGMENTS BECOMING DISLODGED INTO THE PATIENT'S MENISCUS. X-RAYS WERE UTILIZED TO IDENTIFY AND LOCATE THE RETAINED NEEDLE FRAGMENTS. APPROXIMATELY ONE HOUR OF ADDITIONAL SURGICAL TIME WAS REQUIRED TO LOCATE AND RETRIEVE THE BROKEN NEEDLE PIECES FROM THE PATIENT. DUE TO THE PRESENCE OF RETAINED FRAGMENTS AND THE EFFORTS REQUIRED FOR RETRIEVAL THE PLANNED MENISCUS REPAIR PROCEDURE COULD NOT BE COMPLETED AS INTENDED. INSTEAD, A PARTIAL LATERAL MENISCECTOMY WAS PERFORMED IN ORDER TO REMOVE THE NEEDLE FRAGMENTS ALONG WITH THE AFFECTED MENISCAL TISSUE. THE EVENT RESULTED IN PATIENT INVOLVEMENT, MEDICAL INTERVENTION, AND A SURGICAL DELAY. PHOTOGRAPHS OF THE BROKEN NEEDLES AND X-RAYS WERE PROVIDED WITH THE COMPLAINT.

  Patient problems: Laceration(s)

  MAUDE report 25427387 ↗
• MalfunctionApr 23, 2026Material Integrity Problem

  LINCOTEK MEDICAL WAS NOTIFIED BY STRYKER ON 04/08/2026 OF A NEEDLE BREAKAGE EVENT THAT OCCURRED AT THE SURGICAL SITE. DURING A MENISCUS ROOT REPAIR PROCEDURE USING THE VERIPASS SUTURE PASSER AND NEEDLE, TWO NEEDLE TIPS FRACTURED WITHIN THE PATIENT. ONE FRAGMENT WAS SUCCESSFULLY RETRIEVED, WHILE THE OTHER REMAINED EMBEDDED IN THE MENISCAL TISSUE AT THE SITE OF BREAKAGE. THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE, WHICH WAS COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED DELAY. HOWEVER, THE ADVERSE OUTCOME WAS THAT ONE NEEDLE TIP REMAINED IN THE PATIENT'S MENISCUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972039 ↗