RUSCH IPN050521Recalls & reported problems
Teleflex Incorporated · RUSCH Gold 2 Way Foley Catheter · Class 2
All models of RUSCH (220)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704302304), received between Mar 15, 2023 and Mar 10, 2025 — classified as 2 injuries, 3 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
- Manufacturing, Packaging or Shipping Problem1
- Pumping Problem1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED "THE CUSTOMER ADVISED THAT THE BALLOON WOULD NOT DEFLATE. THE PATIENT HAD TO BE TAKEN TO SURGERY AS A RESULT". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: Insufficient Information
MAUDE report 21560482 ↗InjuryFeb 7, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT: "THE CUSTOMER ADVISED THAT THE BALLOON WOULD NOT DEFLATE. THIS OCCURRED DURING TWO DIFFERENT PROCEDURES AND ONE OF THE TWO PROCEDURES WAS SO BAD THAT THE PATIENT HAD TO BE TAKEN TO SURGERY AS A RESULT".AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: Insufficient Information
MAUDE report 21333604 ↗MalfunctionSep 4, 2024Pumping Problem; Pumping Problem
IT WAS REPORTED THAT " BALLOOM IS CRUSHING/PINCHING THE FOLEY". ADDITIONAL INFORMATION STATES THAT THE CATHETER WAS REMOVED URGENTLY AND REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "GOOD".
Patient problems: Insufficient Information
MAUDE report 20138016 ↗MalfunctionMar 15, 2023Deflation Problem; Deflation Problem
REPORTED ISSUE: ONE PARTIALLY DEFLATED; ONE DID NOT DEFLATE WHICH PRESENTED A REMOVAL PROBLEM. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16550852 ↗MalfunctionMar 15, 2023Deflation Problem; Deflation Problem
REPORTED ISSUE: ONE PARTIALLY DEFLATED; ONE DID NOT DEFLATE WHICH PRESENTED A REMOVAL PROBLEM. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16550846 ↗
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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