Bard® X-Force® Balloon Dilation Catheter 997710Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741052149), received between Apr 3, 2017 and Jan 29, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2018Kinked

  IT WAS REPORTED THAT DURING SAMPLE EVALUATION, THE SAMPLE ALSO HAD A KINK IN IT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7225807 ↗
• MalfunctionDec 14, 2017Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED AFTER 30 SECONDS OF PUMPING THE BALLOON DUE TO A SEVERE URETERAL STRICTURE.

  Patient problems: No Information

  MAUDE report 7116493 ↗
• MalfunctionApr 3, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON LEAKED. IT WAS LATER REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A URETERAL STRICTURE. THE CATHETER BALLOON WAS DILATED AT THE URETER OF THE PATIENT. THERE WAS NO RESISTANCE WHEN INSERTING THE CATHETER. THE BALLOON CATHETER WAS PLACED AND DILATED AT THE URETER FOR ABOUT TWO MINUTES, AFTER WHICH THE BALLOON CATHETER BEGAN TO LEAK. THE PROCEDURE; HOWEVER, WAS COMPLETED WITHOUT ANY FURTHER REPORTED PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6455009 ↗