NA 2C0415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412000343), received between Aug 23, 2022 and Jun 27, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 27, 2024No Flow; No Flow

  IT WAS REPORTED THAT DURING USE OF AN UNSPECIFIED QUANTITY OF SOLUTION TRANSFER SETS, THE TRANSFER OF FLUIDS TOOK A LONG TIME. THE EVENT WAS FURTHER DESCRIBED AS "NOT A SMOOTH TRANSFER". THIS OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629731 ↗
• MalfunctionAug 23, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING OF FIFTEEN (15) SOLUTION TRANSFER SETS WERE DAMAGED. THE DAMAGED PACKAGING WAS FURTHER DESCRIBED AS, ¿PACKAGING WAS DETERIORATING¿. THE DAMAGED PACKAGING WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279850 ↗