Ureteral Catheter M0064002120Recalls & reported problems
Boston Scientific Corporation · Cone Tip Ureteral Catheter · Class 2
All models of Ureteral Catheter (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729751670), received between Jul 19, 2021 and Jul 19, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (2 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
Device problems
- Defective Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2021Defective Device; Defective Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED IN THE KIDNEY DURING A RETROGRADE PYELOGRAM PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO THE BLADDER AND WAS UNDER DIRECT VISUALIZATION. IT WAS NOTICED THAT THE CATHETER HAS A BURR ON THE CONE PORTION OF THE CATHETER. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12188053 ↗MalfunctionJul 19, 2021Defective Device; Defective Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED IN THE KIDNEY DURING A RETROGRADE PYELOGRAM PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO THE BLADDER AND WAS UNDER DIRECT VISUALIZATION. IT WAS NOTICED THAT THE CATHETER HAS A BURR ON THE CONE PORTION OF THE CATHETER. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12188047 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page