MULTI HOLE 6 20121800Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B458201218000), received between Jul 14, 2025 and Jul 14, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Material Separation; Solder Joint Fracture; Material Separation; Solder Joint Fracture

  THE CUSTOMER REPORTED THAT DURING A LIPOSUCTION PROCEDURE, THE CANNULA SHAFT DETACHED FROM THE BASE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE CANNULA, AND THERE WERE NO REPORTED INJURIES OR PROCEDURAL DELAYS. THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE CANNULA SHAFT WAS BENT AND HAD SEPARATED FROM THE BASE. THE SOLDER JOINT WAS FRACTURED, AND A DENT WAS OBSERVED IN THE STAINLESS-STEEL HUB, INDICATING MECHANICAL STRESS. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE PRODUCT MET ALL MANUFACTURING SPECIFICATIONS AND PASSED INSPECTION WITH NO NONCONFORMITIES OR DEVIATIONS NOTED. THE INSTRUCTIONS FOR USE (MKT-2901 REV. 01) FOR CANNULAS ADVISES AGAINST BENDING OR APPLYING EXCESSIVE FORCE TO THE DEVICE, AS THESE ACTIONS MAY COMPROMISE STRUCTURAL INTEGRITY. THE TOTALITY OF THE EVIDENCE INDICATES THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND THAT NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED. THE OBSERVED DAMAGE IS CONSISTENT WITH MECHANICAL FORCE APPLIED BY THE USER AND IS ATTRIBUTED TO HANDLING OR USE THAT DEVIATES FROM THE CONDITIONS DESCRIBED IN THE INSTRUCTIONS FOR USE. THIS INCIDENT IS CONSIDERED ISOLATED, AS NO OTHER COMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22497544 ↗