RUSCH IPN050169Recalls & reported problems
Teleflex Incorporated · 100% Silicone Foley Balloon Catheter (2 Way) · Class 2
All models of RUSCH (220)
Data updated Oct 18, 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 04026704334957), received between Nov 18, 2022 and Apr 12, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel2
- Deflation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2023Burst Container or Vessel; Burst Container or Vessel
REPORTED ISSUE: THE BALLOON RUPTURED UPON INSERTION. THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16727339 ↗MalfunctionMar 9, 2023Deflation Problem; Deflation Problem
REPORTED ISSUE: BOTH DEFLATED AND PULLED OUT. ONE SEEMED TO HAVE A PIN HOLE IN THE BALLOON AND ANOTHER JUST LOOKED LIKE THE BALLOON WAS DEFECTIVE. NO INJURY REPORTED. ASSOCIATED MDR#S: 8040412-2023-00082; 8040412-2023-00083.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16515827 ↗MalfunctionMar 9, 2023Deflation Problem; Deflation Problem
REPORTED ISSUE: BOTH DEFLATED AND PULLED OUT. ONE SEEMED TO HAVE A PIN HOLE IN THE BALLOON AND ANOTHER JUST LOOKED LIKE THE BALLOON WAS DEFECTIVE. NO INJURY REPORTED. ASSOCIATED MDR#S: 8040412-2023-00082; 8040412-2023-00083.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16515536 ↗MalfunctionNov 18, 2022Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON POPPED. THERE WAS MINIMAL HARM, A LITTLE BIT OF BLOOD NOTED. THE PATIENT DID EXPERIENCE SOME DISCOMFORT AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15826824 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 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.
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