Bard® X-Force® Balloon Dilation Catheter 997610Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741052118), received between Nov 30, 2018 and Jun 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2020Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS EXPLODED DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10155493 ↗
• MalfunctionNov 30, 2018Use of Device Problem; Deflation Problem; Display or Visual Feedback Problem; Use of Device Problem

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE BALLOON WAS NOT DEFLATING COMPLETELY WHEN IT WAS TIME TO REMOVE THE BALLOON FROM THE URETER FOLLOWING DILATION. UPON TESTING, THE BALLOON DEFLATED NORMALLY. THE BARD SALES REP. STATED THE ISSUE STEMMED FROM THE FACT THAT THE USER (THE SCRUB TECH) WAS NOT WAITING LONG ENOUGH FOR THE VACUUM EFFECT TO TAKE FULL EFFECT. IN ORDER TO DEFLATE THE BALLOON, THE INFLATOR SHOULD BE DEPLOYED BACK FULLY TO ALLOW THE PRESSURE TO PULL ALL OF THE FLUID OUT OF THE BALLOON AND DEFLATE IT. FINAL CONCLUSION WAS THAT THE PRODUCT WAS WORKING PROPERLY AND THIS EVENT WAS A USER ERROR.

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

  MAUDE report 8120912 ↗