LoFric® Hydro-Kit™ 42312Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 12FR · Class 2
Data updated Oct 18, 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 07392532142673), received between Aug 21, 2020 and Aug 21, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.
Most reported problems
Device problems
- Material Rupture1
Patient problems
- Foreign Body In Patient1
- Pain1
- 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.
InjuryAug 21, 2020Material Rupture; Material Rupture
THE PATIENT EXPERIENCED PROBLEMS WHILE PERFORMING INTERMITTENT CATHETERIZATION. THE PATIENT REPORTS THAT SHE HAS EXPERIENCED PAIN, HIGH TEMPERATURE AND URINARY TRACT INFECTIONS. THE PATIENT WENT TO HOSPITAL AND A CYTOSCOPY WAS PERFORMED WHERE BROKEN URINARY CATHETER TIPS WERE DISCOVERED AND SUBSEQUENTLY REMOVED FROM THE BLADDER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY, GIVEN A LOW DOSE OF ANTIBIOTICS FOR PROPHYLAXIS TO USE FOR 5-6 MONTHS AND ALSO REPORTS TAKING PAIN MEDICATION AFTER THE CYTOSCOPY. THE PATIENT REPORTS THAT SHE SINCE THE DISCHARGE SHE IS USING FOLEY CATHETERS, AND ACCORDING TO THE DOCTOR´S ADVICE SHE CAN PERFORM INTERMITTENT CATHETERIZATION OR USE THE FOLEY CATHETER AS AN INDWELLING CATHETER.
Patient problems: Foreign Body In Patient; Pain; Urinary Tract Infection
MAUDE report 10436437 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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