UroForce® Balloon Dilation Catheter 887610Recalls & reported problems

C. R. Bard, Inc. · UroForce® Balloon Dilation Catheter · Class 2

All models of UroForce Balloon Dilation Catheter (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801741053020), received between Sep 14, 2022 and Sep 14, 2022 — classified as 1 malfunction.

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

Device problems

Burst Container or Vessel1
Material Puncture/Hole1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 14, 2022Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole
IT WAS REPORTED THAT THERE WAS A LEAK IN A DILATION CATHETER BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15417843 ↗

Device details

UDI-DI	`10801741053020`
Brand	UroForce® Balloon Dilation Catheter
Model	887610
Company	C. R. Bard, Inc.
Product code	EZN · DILATOR, CATHETER, URETERAL
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 31, 2023

Device type (GMDN): Ureteral catheter

A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.

Other DILATOR, CATHETER, URETERAL devices

Porges Coloplast RBD014
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1 recall0 reports
Bard® X-Force® Balloon Dilation Catheter 998706
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38 reports
Bard® X-Force® Balloon Dilation Catheter 998606
C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL
27 reports
Bard® X-Force® Balloon Dilation Catheter 998006
C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL
25 reports
Bard® X-Force® Balloon Dilation Catheter 998806
C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL
23 reports
Bard® X-Force® Balloon Dilation Catheter 998504
C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL
16 reports
Bard® X-Force® Balloon Dilation Catheter 998004
C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL
15 reports
Bard® X-Force® Balloon Dilation Catheter 998506
C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL
15 reports

All DILATOR, CATHETER, URETERAL devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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