N/A 9735018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169443532), received between Nov 14, 2017 and Jan 26, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission 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. 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.

• MalfunctionJan 26, 2018Communication or Transmission Problem; Material Integrity Problem; Communication or Transmission Problem; Material Integrity Problem

  A SITE REPRESENTATIVE REPORTED THAT DURING PITUITARY LUMPECTOMY, THE MALLEABLE SUCTION HAD RECOGNITION FAILURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF BACK UP INSTRUMENT. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7222045 ↗
• MalfunctionNov 14, 2017Device Stops Intermittently; Device Operates Differently Than Expected; Device Stops Intermittently; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING TRANSNASAL ENDOSCOPIC PITUITARY SURGERY, THE MALLEABLE SUCTION WAS SUCCESSFULLY REGISTERED AT THE BEGINNING OF THE PROCEDURE HOWEVER DURING THE CASE THE SUCTION HAD RECOGNITION FAILURE. A DIFFERENT MALLEABLE SUCTION WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7031200 ↗