LoFric® Hydro-Kit™ 42514Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 14FR · Class 2
Data updated Oct 16, 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 07392532148569), received between Mar 9, 2020 and Mar 9, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, THE PATIENT HAS EXPERIENCED ALLERGIC REACTIONS (REDNESS, INFLAMMATION) WHEN USING THE URINARY CATHETER LOFRIC HYDROKIT. THE PATIENT HAS USED CATHETERS FOR AROUND 15 YEARS, THE ALLERGIC REACTIONS OCCURRED IN (B)(6) 2020. THE ALLERGIC REACTION WAS LOCALIZED ON THE GENITALS, NO OTHER PART OF THE BODY WAS AFFECTED. THE PATIENT USES THE SAME WIPES AND SOAP PRODUCTS AS BEFORE THE ALLERGIC REACTIONS OCCURRED. THERE WERE NO OTHER MEDICAL COMPLICATIONS. THE DOCTOR PRESCRIBED MEDICATION, AND THE PATIENT HAS RECOVERED. THE INCIDENT OCCURRED IN (B)(6).
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 9804522 ↗
Other CATHETER, STRAIGHT devices
- Magic3 Go Male Catheter with SureGrip 53814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall490 reports
- Magic3 Go Male Coude Catheter with SureGrip 50814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall3 deaths416 reports
- Magic3 Go™ Intermittent Urinary Catheter 51814C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall327 reports
- Magic3 Go Male Coude Catheter with SureGrip 50816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall239 reports
- Magic3 Go Male Catheter with SureGrip 53816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall164 reports
- Magic3 Go Male Catheter with SureGrip 53812GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall120 reports
- Magic3 Go™ Intermittent Urinary Catheter 51812C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall109 reports
- CURE CATHETER HM14Convatec, Purchasing Department · Catheter, Straight154 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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