Dover 7016MFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521050617), received between Mar 9, 2020 and Dec 13, 2021 — classified as 1 injury, 1 malfunction.

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

• MalfunctionDec 13, 2021Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT A FOLEY CATHETER WAS PLACED WHEN A PATIENT UNDERWENT SURGERY BUT THE FOLEY CATHETER COULD NOT BE REMOVED IN THE USUAL WAY BECAUSE IT WAS NOT ABLE TO BE DEFLATED COMPLETELY SO THE DOCTOR HAD TO REMOVE IT IN THE END. THERE WAS NO PATIENT HARM. IT IS NOT KNOWN IF THE CUSTOMER TESTED THE DEVICE DURING PREP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987239 ↗
• InjuryMar 9, 2020Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE BALLOON INFLATE WAS CHECKED BEFORE USE. WHEN TRYING TO REMOVE THE CATHETER 10 DAYS AFTER IT WAS INSERTED, ONLY 5ML OF WATER WAS PULLED FROM THE BALLOON, AND THE CATHETER WAS UNABLE TO BE REMOVED. THE CATHETER WAS REMOVED BY BREAKING THE BALLOON BY PUTTING 170ML OF WATER IN THE BALLOON. THE CUSTOMER FURTHER STATED THAT THERE WERE FRAGMENTED PIECES LEFT IN THE PATIENT THAT WERE LATER REMOVED BY CYSTOSCOPE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9807820 ↗