Bard® X-Force® Nephrostomy Balloon Dilation Catheter 996101Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10801741127660), received between Aug 9, 2017 and Dec 9, 2025 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER ORDERED 2 BOXES REF: (B)(4), LOT: BMKZFM16, CUSTOMER NORMALLY RECEIVES A GREEN BOX, HOWEVER THEY RECEIVED A BLUE BOX WITH THE SAME MATERIAL AND LOT NUMBER LISTED ON IT. THE GREEN BOX HAS THE PTA SHEET IN IT, WHILE THE BLUE BOX RECEIVED, HAS PICTURES SHOWING THE SHEET WAS SUPPOSED TO BE IN IT. HOWEVER, THEY WERE NO SHEETS CONTAINED IN THE TWO BOXES. CUSTOMER WOULD LIKE SOMEONE REACH OUT TO THEM AS SOON AS POSSIBLE AS THEY HAD AN UPCOMING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764877 ↗
• MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO PERFORMING URETERAL STRICTURE DILATION SURGERY, WHEN OPENING THE URETERAL STRICTURE BALLOON FOR USE, A NOTICEABLE LEAK WAS OBSERVED IN THE PRESSURE PUMP. REPLACED THE BALLOON SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485367 ↗
• MalfunctionApr 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE, BALLOON DILATION CATHETER BALLOON DEFLATED. AN ISSUE THEY ENCOUNTERED WITH ONE OF NEPHROSTOMY BALLOON DILATION CATHETER BALLOONS DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. AFTER FULL INFLATION, THEY OBSERVED A GRADUAL DECREASE IN PRESSURE, AND UPON FURTHER INSPECTION, THEY DISCOVERED A HOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21813678 ↗
• MalfunctionOct 19, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CUSTOMER WAS IN PROCEDURE ON 12JUNE, THE BALLOON DILATION DEVICE WOULD NOT LOCK. SEPARATE KIT OPENED TO OBTAIN DILATION PART. THERE WAS ONLY A DELAY IN CARE NO PATIENT HARM. THE CUSTOMER WAS GOING TO CONTACT CAROL PRICE TERRITORY MANAGER FOR REPLACEMENT PRODUCT. CUSTOMER HAD AFFECTED PRODUCT FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966819 ↗
• MalfunctionOct 9, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT ONCE THE PACKAGE WAS OPENED, THE DOCTOR FOUND THAT THE BALLOON PUMP WAS DAMAGED ON THE BALLOON DILATION CATHETER. THE DEVICE WAS NOT USED IN THE PATIENT. IT WAS STATED THAT THEY REPLACED WITH A NEW BALLOON. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 26SEP2023, THE BALLOON PUMP INDICATING BALLOON OF THE DILATION CATHTER AND THE DAMAGE INDICATING BALLON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894825 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED A PERFORATION ADVERSE EVENT, DIRECTLY ATTRIBUTABLE TO THE DEVICE 996101 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 10MM X 15CM, W/ INFLATION DEVICE, STERILE. ALSO STATING THAT THE PATIENT WITH THE DEVICE 996101 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 10MM X 15CM, W/ INFLATION DEVICE, STERILE PLACEMENT DID RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION BECAUSE SURGICAL REPAIR. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 14JUN2023, IN AN ONLINE SURVEY, A PHYSICIAN STATED A PERFORATION ADVERSE EVENT, DIRECTLY ATTRIBUTABLE TO THE DEVICE 996101 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 10MM X 15CM, W/ INFLATION DEVICE, STERILE. PHYSICIAN ALSO INDICATED PERFORATION WAS PRESENT PRIOR TO PLACEMENT OF THE DEVICE. ALSO STATING THAT THE PATIENT WITH THE DEVICE 996101 - X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER, 10MM X 15CM, W/ INFLATION DEVICE, STERILE PLACEMENT DID RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION BECAUSE SURGICAL REPAIR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation

  MAUDE report 17208560 ↗
• MalfunctionMay 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PHYSICIAN IN AN ONLINE SURVEY STATED THAT THEY WERE NOT ABLE TO SUCCESSFULLY DILATE THE NEPHROSTOMY TRACT. THE PHYSICIAN WAS NOT ABLE TO SUCCESSFULLY DILATE THE NEPHROSTOMY TRACT FOR THE DEVICE 996101 - BALLOON DILATION CATHETER BECAUSE OF PERSONAL EXPECTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002019 ↗
• MalfunctionApr 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER OPENING THE PRODUCT, WHEN THE CUSTOMER STARTED TO INFLATE THE BALLOON, THE DOCTOR NOTICED THE BALLOON WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732507 ↗
• MalfunctionJan 27, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON IN THE PERCUTANEOUS DILATION CATHETER HAD A HOLE IN IT. IT WAS STATED THAT THE DOCTOR HAD TO RESTART WITH A DIFFERENT BALLOON FROM A COMPETITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13374864 ↗
• MalfunctionDec 15, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE BALLOON IN THE DILATION CATHETER WAS PINCHED. CUSTOMER HAD TO OPEN A NEW BALLOON AND THEN IT WORKED FINE. STATED THE PRODUCT WAS DEFECTIVE AND NO IMPACT TO THE PATIENT. THE BALLOON WAS PINCHED IN THE MIDDLE WHILE INFLATING DURING A PERCUTANEOUS NEPHROLITHONOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010764 ↗
• MalfunctionJul 28, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER BALLOON WAS FOUND DAMAGED WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239197 ↗
• MalfunctionJun 22, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE DOCTOR CANNOT SEE THE BALLOON ON THE FLUORO IMAGING WHEN THE CONTRAST WAS INJECTED INTO THE BALLOON. NO IMPACT TO THE PATIENT AND DOCTOR OPENED NEW BALLOON AND CASE WENT WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041632 ↗
• MalfunctionFeb 10, 2020Break; Material Puncture/Hole; Break

  IT WAS REPORTED THAT WHILE TRYING TO TIGHTEN THE X-FORCE DEVICE, A HOLE WAS DISCOVERED.

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

  MAUDE report 9687692 ↗
• MalfunctionFeb 8, 2020Burst Container or Vessel; Component Missing; Burst Container or Vessel

  IT WAS REPORTED THAT PART OF THE BALLOON WAS MISSING.

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

  MAUDE report 9684979 ↗
• MalfunctionDec 20, 2019Use of Device Problem; Inflation Problem; Material Puncture/Hole; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE BALLOON ON THE INFLATION DEVICE.

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

  MAUDE report 9503842 ↗
• MalfunctionJun 20, 2019Inflation Problem; Inflation Problem; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BALLOON WAS USED IN PCNL SURGERY, THE PUMP PUSHER CANNOT PUSH, AND THE FLUID CANNOT BE INJECTED INTO THE BALLOON.

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

  MAUDE report 8718988 ↗
• MalfunctionJun 18, 2019Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED THAT THE BALLOON WAS USED DURING A PCNL SURGERY AND LEAKAGE OCCURRED FROM THE PUMP TO THE BALLOON. IT WAS ALSO NOTED THAT FLUID COULD NOT BE INJECTED INTO THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8708256 ↗
• MalfunctionFeb 14, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON RUPTURED UPON INFLATION.

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

  MAUDE report 8340010 ↗
• MalfunctionFeb 14, 2019Break

  IT WAS REPORTED THAT UPON PRESSING THE BALLOON WITH A PUMP, THE PRESSURE GAUGE WAS FOUND BROKEN.

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

  MAUDE report 8339621 ↗
• MalfunctionJan 29, 2019Component Missing

  IT WAS REPORTED THAT A COMPONENT WAS MISSING FROM THE XFORCE PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT VIA EMAIL ON 16JAN2019, THAT THE INFLATION DEVICE WAS MISSING FROM THE PACKAGING.

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

  MAUDE report 8285440 ↗
• MalfunctionMay 29, 2018Break; Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON WAS DAMAGED WHILE DILATING PRESSURE WAS BEING APPLIED.

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

  MAUDE report 7550283 ↗
• InjuryDec 12, 2017Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON HAD BURST WITH A SMALL AMOUNT OF SELF LIMITED BLEEDING. THE PROCEDURE WAS URETHRAL STRICTURE BALLOON DILATATION SURGERY, PRESSURE TO 25 ATM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 7107949 ↗
• MalfunctionAug 31, 2017Burst Container or Vessel

  IT WAS REPORTED THAT THE URETHRAL STRICTURE BALLOON COMPRESSION WAS 25 ATMOSPHERIC PRESSURE, AND THE BALLOON BURST. A SMALL AMOUNT OF BLEEDING WAS OBSERVED IN THE PATIENT. HOWEVER, THERE WERE NO MISSING PIECES FROM THE BALLOON.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6835075 ↗
• MalfunctionAug 9, 2017Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6780503 ↗