SpeediCath Compact 28582Recalls & reported problems
Coloplast A/S · SpeediCath Compact female CH12 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932020565), received between Jun 14, 2016 and Feb 17, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
- Device Contamination with Chemical or Other Material1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2017Break; Detachment Of Device Component
ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, CUSTOMER FOUND THAT THE CATHETER DID NOT BREAK OFF INSIDE OF HER. WHAT SHE FOUND WAS THAT THE CATHETER BROKE OFF AND WENT INTO THE PACKAGING AND SAID THAT IF SHE TWISTS IT A CERTAIN WAY, THEN IT BREAKS. SHE SAID THAT IT WASN'T THE FAULT OF THE PRODUCTS... JUST THE WAY SHE TWISTS THE CATHETER AND IS GOING TO BE MORE CAREFUL.
Patient problems: Foreign Body In Patient
MAUDE report 6339883 ↗MalfunctionJun 14, 2016Device Contamination with Chemical or Other Material
ACCORDING TO THE INFORMATION RECEIVED, MOTHER FOUND ONE CATHETER WITH BROWN LIQUID INSIDE HER DAUGHTER'S BOX OF 30 SPEEDICATH CATHETERS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5723606 ↗
Other Catheter, straight devices
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- 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 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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