HARVEST® 51401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05020583514010), received between Jun 25, 2020 and Jun 25, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  THE SET WAS BEING USED FOR PLATELET-RICH PLASMA (PRP) FOR THE HAIR RESTORATION PROCEDURE. THE CUSTOMER WAS AWARE THEY WERE USING EXPIRED SETS AND REPLACED THE ACD-A FROM THE SET BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10196887 ↗
• MalfunctionJun 25, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  THE SET WAS BEING USED FOR PLATELET-RICH PLASMA (PRP) FOR THE FACIAL. THE CUSTOMER WAS AWARE THEY WERE USING EXPIRED SETS AND REPLACED THE ACD-A FROM THE SET BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10196879 ↗
• MalfunctionJun 25, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  THE SET WAS BEING USED FOR PLATELET-RICH PLASMA (PRP) FOR THE KNEE SURGERY. THE CUSTOMER WAS AWARE THEY WERE USING EXPIRED SETS AND REPLACED THE ACD-A FROM THE SET BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10196874 ↗