MicroAire® PAL-30MLMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847399008312), received between Aug 22, 2022 and Sep 24, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2022Fracture; Fracture

  DOCTOR PERFORMING BILATERAL BREAST FAT GRAFTING. WHILE PREFORMING THE FAT GRAFTING, DOCTOR NOTED SOMETHING LOOKED OFF WITH THE FAT GRAFTING CANNULA MID USE AND REALIZED THE TIP WAS MISSING. RN CIRCULATOR, INFORMED CHARGE NURSE OF THE SITUATION AND CALLED FOR AN X-RAY AT 1004. OR MANAGER NOTIFIED BY CHARGE NURSE. X-RAY TAKEN AND REVEALED BROKEN TIP OF CANNULA IN PATIENT'S BACK. TIP WAS REMOVED BY DOCTOR EASILY AND IN ONE PIECE. REPEAT X-RAY SHOWED NO RETAINED INSTRUMENT FRAGMENTS. X-RAY READ BY RADIOLOGIST AT 1022 AND CONFIRMED THAT THE PIECE HAD BEEN REMOVED. DOCTOR OBSERVED RETRIEVED TIP AN COMPARED IT TO THE CANNULA HANDLE - CONFIRMED THAT ALL PIECES WERE ACCOUNTED FOR. OR MANAGER RETRIEVED PACKAGING FROM TRASH WITH REFERENCE AND LOT NUMBERS AND ALSO NOTIFIED OR DIRECTOR.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15478595 ↗
• MalfunctionAug 22, 2022Break; Component Missing

  DOCTOR PERFORMING BILATERAL BREAST FAT GRAFTING. WHILE PERFORMING THE FAT GRAFTING, DOCTOR NOTED SOMETHING LOOKED OFF WITH THE FAT GRAFTING CANNULA MID USE AND REALIZED THE TIP WAS MISSING. RN CIRCULATOR, INFORMED CHARGE NURSE OF SITUATION AND CALLED FOR AN X-RAY AT 1004. OPERATING ROOM MANAGER NOTIFIED BY CHARGE NURSE. X-RAY TAKEN AND REVEALED BROKEN TIP OF CANNULA IN PATIENT'S BACK. TIP WAS REMOVED BY DOCTOR EASILY AND IN ONE PIECE. REPEAT X-RAY SHOWED NO RETAINED INSTRUMENT FRAGMENTS. X-RAY READ BY RADIOLOGIST AT 1022 AND CONFIRMED THAT THE PIECE HAD BEEN REMOVED. DOCTOR OBSERVED RETRIEVED TIP AND COMPARED IT TO THE CANNULA HANDLE--CONFIRMED THAT ALL PIECES WERE ACCOUNTED FOR. OR MANAGER RETRIEVED PACKAGING FROM TRASH WITH REFERENCE AND LOT NUMBERS AND ALSO NOTIFIED OPERATING ROOM DIRECTOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 15265974 ↗