ACUFEX 72205103Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556715123), received between Jun 12, 2020 and Dec 17, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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.

• InjuryDec 17, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE SURGERY THE DISTAL ATTACHMENT OF THE ACUFEX ACCESS WHERE THE STERILE DRAPES ATTACH WAS NOT SECURING OR RELEASING AS IT SHOULD. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS REPORTED. ALTERNATE POSITIONING DEVICES WHERE USED IN ORDER TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11027841 ↗
• MalfunctionJun 12, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHILE TESTING THE ACUFEX ACCESS LATERAL TRACTION BOOM IS DOWN, THE BLUE RING WON'T LOCK. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10151139 ↗