Lipogems Process Device 240 M LGD 240Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08058773562432), received between Aug 27, 2019 and Aug 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 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.

• InjuryAug 27, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  COMPLIANT WAS REVIEWED AND DEEMED REPORTABLE DURING 2019 AUDIT. THE INFILTRATION CANNULA WAS NOT PROPERLY HANDLED, PER THE IFU. FAILURE TO FOLLOW MANUFACTURER'S INSTRUCTION FOR USE DURING THE INITIAL INSERTION BY THE SURGEON, AND REUSING THE SAME CANNULA AFTER NOTING THAT IT WAS BENT, WAS CAUSE OF THE TIP BEING BROKEN IN THE PATIENT. EXCESSIVE FORCE WAS USED DURING SURGEON'S INITIAL INSERTION CAUSING IT TO BEND. THERE WAS A SECOND CANNULA OPENED TO REPLACE THE BENT ONE, HOWEVER THE SURGEON AGAIN USED THE BENT CANNULA ON THE PATIENT AND THE TIP BROKE OFF. INFILTRATION CANNULA TIP WAS LEFT IN THE PATIENT AT DISCRETION OF THE SURGEON. THE SURGEON HAS ADVISED THAT HE DID INFORM THE PATIENT OF THE SITUATION AND IN HIS PROFESSIONAL OPINION DID NOT FEEL THAT THE PIECE REMAINING INSIDE WOULD BE A PROBLEM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8937292 ↗