LoFric® Sense™ 4161025Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH10 / Nelaton 6" 10FR, 5-pack. For females. Sterile device. · Class 2
Data updated Oct 18, 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 07333387021737), received between Dec 22, 2025 and Dec 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
PRODUCT PROBLEM OCCURRED OUTSIDE US, IN GREAT BRITAN. FEMALE PATIENT USING LOFRIC SENSE, A STERILE, SINGLE-USE INTERMITTENT URINARY CATHETER. THE PRIMARY PACKAGING CONTAINS A WATER SACHET FOR LUBRICATING THE COATING. PATIENT CONTACTED US ON DECEMBER 11TH. PATIENT STATES THAT WHEN SQUEEZING THE SACHET, THE WATER BURST OUT OF THE BOTTOM OF THE PRIMARY PACKAGE. THIS HAPPENED ON SIX PRODUCTS. THE PATIENT DID NOT USE THEM BUT HAD OTHER NON-FAULTY PRODUCTS AVAILABLE THAT SHE COULD USE. SHE DISCARDED THE SIX FAULTY CATHETERS. NO HARM OR HEALTH IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865089 ↗
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- 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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