RUSCH IPN052065Recalls & reported problems
Teleflex Incorporated · All Purpose Catheter Robinson/Nelaton · Class 2
All models of RUSCH (220)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704304011), received between Aug 17, 2022 and Aug 17, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sharp Edges” (1 report).
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
- Sharp Edges1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2022Sharp Edges; Sharp Edges
CUTS AS YOU INSERT AND MAKES CUSTOMER BLEED. DID NOT STATE IF THEY NEEDED MEDICAL ATTENTION. ADDITIONAL INFORMATION: MEDICAL ATTENTION NOT NOTED IN THIS CASE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information
MAUDE report 15245052 ↗
Other CATHETER, UROLOGICAL devices
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- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
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- 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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