Porges Coloplast AA6320Recalls & reported problems
Coloplast A/S · FOLYSIL® catheter Tiemann CH FR 20 · Class 2
All models of Porges Coloplast (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03600040129036), received between Mar 9, 2023 and May 25, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Dec 2, 2024Class IIOpen, Classified
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Z-0844-2025 · Root cause: Packaging · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2023Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A FISSURE IN THE BALLOON AND WAS NOT WORKING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17004238 ↗MalfunctionMar 9, 2023Break; Break
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO LOOSE TIP. THE DEVICE TIP CAME LOOSE WHEN SEPARATING THE PROTECTIVE COVER AND INNER STERILE PACKAGING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16517858 ↗
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- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 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 · each recall links to the FDA recall notice
- 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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