RUSCH IPN051269Recalls & reported problems
Teleflex Incorporated · Coude Foley Catheter Pure Gold PTFE Coated · Class 2
All models of RUSCH (220)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026704303106), received between Sep 27, 2021 and Mar 2, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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 16, 2026.
Most reported problems
Device problems
- Obstruction of Flow2
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2023Obstruction of Flow; Obstruction of Flow
REPORTED ISSUE: THE CATHETERS STOPPED DRAINING. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16467581 ↗MalfunctionDec 22, 2022Obstruction of Flow; Obstruction of Flow
REPORTED ISSUE: CUSTOMER STATES CATHETER IS NOT DRAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16039676 ↗MalfunctionSep 27, 2021No Flow; No Flow
FOLEY WAS CLOGGED AND WOULD NOT VOID. PATIENT HAD TO REMOVE AND USE ANOTHER. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12532184 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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