C-MAX 20155000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B458201550000), received between Jan 16, 2026 and Jan 16, 2026 — 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.

• MalfunctionJan 16, 2026Material Separation; Solder Joint Fracture

  DURING A CLINICAL PROCEDURE, AN INFILTRATION CANNULA WAS REPORTED TO HAVE SEPARATED AT THE SHAFT-TO-BASE INTERFACE DURING USE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE CANNULA, AND NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME OCCURRED. THE AFFECTED DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, THE INVESTIGATION WAS LIMITED TO REVIEW OF CUSTOMER PROVIDED PHOTOGRAPHS AND INTERNAL MANUFACTURING RECORDS. REVIEW OF THE PHOTOGRAPHS CONFIRMED SEPARATION OF THE CANNULA SHAFT FROM THE BASE, WITH NO OBVIOUS BENDING, DEFORMATION, OR EXTERNAL DAMAGE VISIBLE; INTERNAL JOINT INTEGRITY COULD NOT BE EVALUATED IN THE ABSENCE OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH APPROVED SPECIFICATIONS, WITH ALL REQUIRED IN-PROCESS AND FINAL INSPECTIONS COMPLETED AND ACCEPTED AND NO DEVIATIONS, NONCONFORMANCE'S, OR REWORK DOCUMENTED. BASED ON THE AVAILABLE INFORMATION, THE EVENT IS CLASSIFIED AS AN UNDETERMINED MECHANICAL FAILURE AT THE SHAFT-TO-BASE INTERFACE. THE REPORTED FAILURE MODE IS CONSISTENT WITH SEPARATION THAT MAY OCCUR UNDER LATERAL STRESS OR EXCESSIVE MECHANICAL LOADING WHICH CAN COMPROMISE STRUCTURAL INTEGRITY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101610 ↗