RUSCH IPN051271Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04026704303113), received between Feb 27, 2023 and Mar 29, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation Problem3
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2024Deflation Problem; Deflation Problem
IT WAS REPORTED "THE RETENTION BALLOON FAILED TO DEFLATE WHEN REMOVAL WAS ATTEMPTED. THE CATHETER SHAFT WAS CUT AND THE CATHETER WAS ABLE TO BE REMOVED AFTER THE STERILE WATER DRAINED VIA THE CUT CATHETER SHAFT". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Insufficient Information
MAUDE report 19005822 ↗MalfunctionMar 13, 2023Deflation Problem; Deflation Problem
REPORTED ISSUE: SOME OF THE CATHETERS WILL NOT DEFLATE. SOME LEAK SO WE ARE NOT OBTAINING THE SAME CC THAT IS PUT INTO THE BALLOON. THE CHANNEL PROXIMAL TO THE Y WAS LEAKING, SO WHEN INFLATING THE BALLOON THE STERILE WATER WAS SPRAYING OUT. ASSOCIATED REPORT 8040412-2023-00102.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16530403 ↗MalfunctionMar 13, 2023Leak/Splash; Leak/Splash
REPORTED ISSUE: SOME OF THE CATHETERS WILL NOT DEFLATE. SOME LEAK SO WE ARE NOT OBTAINING THE SAME CC THAT IS PUT INTO THE BALLOON. THE CHANNEL PROXIMAL TO THE Y WAS LEAKING, SO WHEN INFLATING THE BALLOON THE STERILE WATER WAS SPRAYING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16529998 ↗MalfunctionFeb 27, 2023Deflation Problem; Deflation Problem
REPORTED ISSUE: THE BALLOON DEFLATED IMMEDIATELY AND IT WAS DISCARDED. IT WAS REPORTED THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16448706 ↗
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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