BD Intermittent RTU12CRecalls & reported problems
Hangzhou Bever Medical Devices Co., Ltd. · BD Ready-To-Use Hydrophilic Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06948796203981), received between Apr 26, 2022 and Apr 26, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Insert” (1 report).
1 other recall cover devices cleared under the same FDA submission (K192468); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Insert1
Patient problems
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE PATIENT HAD TROUBLE IN INSERTING THE INTERMITTENT CATHETER. IT WAS STATED THAT THE PATIENT USED MULTIPLE CATHETERS TO GET A SUCCESSFUL DRAIN AND THOUGHT THEY HAD A URINARY TRACT INFECTION NOW DUE TO THIS INTERMITTENT CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 14213712 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192468. One submission often covers many models, so check the product and lot details in each record.
- Z-1061-2026 · Nov 29, 2025 · Open, ClassifiedBD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Other Catheter, Urethral devices
- Bardex® All-Silicone Foley Catheter 165814C. R. Bard, Inc. · CATHETER, URETHRAL275 reports
- GENTLECATH 421911Convatec, Purchasing Department · Catheter, Urethral234 reports
- GENTLECATH 421910Convatec, Purchasing Department · Catheter, Urethral122 reports
- CURE CATHETER M16CConvatec, Purchasing Department · Catheter, Urethral95 reports
- GENTLECATH 421909Convatec, Purchasing Department · Catheter, Urethral66 reports
- BD Intermittent RTU14FHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 recall3 reports
- Onli 82124Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82164Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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