MicroAire® 22202Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847399006868), received between Feb 28, 2020 and Feb 3, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2023Break; Break

  ON JANUARY 17TH 2023, MICROAIRE WAS NOTIFIED BY THE END-USER/DOCTOR FACILITY THAT A PATIENT'S BROW FELL AFTER A BROW LIFT PROCEDURE WAS COMPLETED ON (B)(6) 2022. THE PATIENT WAS SCHEDULED FOR AN EXPLORATION OF THE SURGICAL SITE ON (B)(6) 2023 AND THE DOCTOR IDENTIFIED THAT THE ENDOTINE IMPLANT HAD BROKEN, THERE WAS NO PATIENT INJURY AND THEY WILL NOT BE RETURNING THE BROKEN IMPLAINT TO MICROAIRE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 16296481 ↗
• MalfunctionFeb 3, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE CUSTOMER STATES THAT A FEMALE PATIENT WAS IMPLANTED WITH CFD-22202 LOT # 374038 ON (B)(6) 2022. THE PATIENT RETURNED TO THE CLINIC FOR A POST-OPERATIVE APPOINTMENT ON (B)(6) 2023 AND THE DOCTOR STATED THAT THE SURGICAL SITE DID NOT FEEL NORMAL. AT THAT TIME THE DOCTOR RE-OPENED THE SURGICAL SITE AND IDENTIFIED THAT THE TINES OF THE IMPLANT WERE BROKEN ON THE IMPLANT AND THE DOCTOR REMOVED THE ORIGINAL (COMPLAINT) IMPLANT AND PLACED ANOTHER IMPLANT WITHIN THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16296369 ↗
• MalfunctionOct 18, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE CUSTOMER STATES THAT THEY DRILLED 3 HOLES ON EACH SIDE OF THE PATIENT AND THE ENDOTINE IMPLANTS WOULD NOT SEAT. USED BACK-UP DEVICES AND THEY WORKED PERFECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625052 ↗
• MalfunctionFeb 28, 2020Mechanical Problem

  IT WAS REPORTED THAT DURING A HAIRLINE LOWERING SURGERY, ENDOTINE IMPLANTS WERE INSERTED INTO THE PATIENT'S SKULL WITHOUT ANY ISSUE; HOWEVER, THEY WOULD NOT SUCCESSFULLY LATCH ON TO THE PATIENT'S SCALP SKIN (GALEAL FLAP) TO COMPLETE THE HAIRLINE LOWERING. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS EXTENDED BY ONE HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772103 ↗