SpeediCath Standard 28412Recalls & reported problems
Coloplast A/S · SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. FR 12/4.0 mm. Rx only. · Class 2
All models of SpeediCath Standard (9)
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 05708932020268), received between May 5, 2021 and May 5, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE REPORT CONCERNS A MAN. HE EXPLAINED ONE CATHETER WAS NOT DRAINING PROPERLY SO HE REMOVED IT AND TRIED TO REINSERT WITH NO SUCCESS. UPON INSPECTION HE NOTICED THE EYELETS WERE MUCH SMALLER COMPARED TO OTHERS. NO PAIN OR BLEEDING OCCURRED. HOWEVER, HE DID EXPERIENCE EXTREME INVOLUNTARY CHILLS AND HAD TO GET AN AMBULANCE WHERE HE WAS HOSPITALIZED FROM (B)(6) 2021. DOCTORS SAID HE WENT SEPTIC AND GAVE HIM ANTIBIOTICS INTRAVENOUSLY AS WELL AS A PRESCRIPTION TO TAKE ORALLY AT HOME. AT FOLLOW-UP IT IS STATED THAT THE END-USER IS NOW RECOVERING, AND HE CONTINUES TO SELF-CATHETERIZE WITH INTERMITTENT CATHETERS. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Sepsis
MAUDE report 11777605 ↗
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 82144Hollister 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 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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