Bard® X-Force® Balloon Dilation Catheter 997606Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741052101), received between Jul 12, 2017 and Nov 11, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER OPENING THE BALLOON DILATION CATHETER PACKAGE, THE LOWER PART OF THE BALLOON HEAD WAS FOUND TO BE OBVIOUSLY DAMAGED. REPLACED WITH A NEW BALLOON FOR THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524035 ↗
• MalfunctionMay 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT BEFORE USE, AFTER BALLOON TESTING, THE BALLOON DILATION CATHETER TIP BECAME BENT AND UNUSABLE. MULTIPLE REINSERTION ATTEMPTS WERE MADE, BUT THE DEVICE COULD NOT BE USED. THE SURGERY WAS COMPLETED USING AN ALTERNATIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960326 ↗
• InjuryJan 8, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE ONCE THE BALLOON DILATION CATHETER HAD BEEN INFLATED, IT CANNOT BE COMPLETELY DEFLATED. THE GUIDE WIRE WOULD SLIP INTO THE URETER AND OUT OF THE GUIDE WIRE BECAUSE THE BALLOON CATHETER WOULD NOT COME OUT OF THE CYSTOSCOPE WORKING CHANNEL. PER ADDITIONAL INFORMATION RECEIVED ON 08JAN2025, IT WAS REPORTED THAT THE ONCE THE BALLOON INFLATED, THE BALLOON CANNOT BE DEFLATED COMPLETELY, WHICH LEADS TO LACERATION IN THE URETER AND LOSS OF THE GUIDE WIRE DUE TO THE BALLOON CATHETER NOT EXITING THROUGH THE CYSTOSCOPE WORKING CHANNEL. URETEROSCOPY WAS PERFORMED WITHOUT A GUIDE WIRE TO POSITION IT, SINCE AFTER THE LACERATION IT WAS IMPOSSIBLE TO PASS THE GUIDE THROUGH A CYSTOSCOPE.

  Patient problems: Laceration(s)

  MAUDE report 21102167 ↗
• MalfunctionMay 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE HEAD END OF THE URETERAL BALLOON CATHETER BALLOON WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249658 ↗
• MalfunctionJul 20, 2021Fluid/Blood Leak; Decrease in Pressure; Fluid/Blood Leak; Decrease in Pressure

  IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, THE OPERATOR FOUND THAT THE CATHETER WAS DAMAGED AND WATER LEAKED FROM THE BALLOON DURING INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198033 ↗
• MalfunctionFeb 1, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE 3 WAY CONNECTION PARTS OF THE CATHETER WERE FOUND TO BE BROKEN. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE IBC ON 14JAN2021, IT WAS CONFIRMED THAT THE EVENT OCCURRED AFTER THE CUSTOMER OPENED THE PRODUCT, AND IT WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11263720 ↗
• MalfunctionJan 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE BALLOON-CATHETER JUNCTION WAS BENT AND FOLDED, THROUGH WHICH THE GUIDE WIRE COULD NOT PASS WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11212492 ↗
• MalfunctionJun 5, 2020Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE POINTER OF THE PUMP DID NOT MOVE WHEN INJECTED WATER INTO THE BALLOON AND IN A REVIEW IT WAS FOUND THAT THE PROXIMAL ROD OF THE BALLOON CATHETER WAS DAMAGED. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL (B)(6) 2020; THE DILATION CATHETER BALLOON CLOSEST TO THE TIP OF THE CATHETER WAS DAMAGED.

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

  MAUDE report 10125786 ↗
• MalfunctionSep 11, 2019Inflation Problem

  IT WAS REPORTED THAT THE X-FORCE BALLOON DID NOT EXPAND.

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

  MAUDE report 8993484 ↗
• MalfunctionAug 6, 2018Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT A URETERAL STENOSIS OPERATION WAS PERFORMED ON THE PATIENT AT 13:10 PM ON (B)(6). DURING THE OPERATION, THE SHAFT ALLEGEDLY RUPTURED WHEN THE WATER WAS PRESSURIZED TO 18 ATMOSPHERES. THE OUTER PACKAGING OF THE PRODUCT WAS CHECKED FOR COMPLETENESS AND ABNORMALITY BEFORE USE. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 FROM (B)(6) , THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION PERFORMED. THERE WAS NO MISSING PIECES.

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

  MAUDE report 7753407 ↗
• MalfunctionJul 12, 2017Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN THE WATER WAS PRESSURIZED TO 17 ATMOSPHERES IN THE COURSE OF URETERAL STENOSIS. THE GUIDE WIRE WAS ABOVE 2CM AWAY FROM THE CATHETER TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6709493 ↗