Porges Coloplast AA6318Recalls & reported problems
Coloplast A/S · FOLYSIL® catheter Tiemann CH FR 18 · 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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03600040128909), received between Jun 8, 2023 and Jul 24, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (4 reports).
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.
Reports received per month
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
- Material Rupture4
- Burst Container or Vessel2
- Delivered as Unsterile Product1
- Device Contaminated During Manufacture or Shipping1
- Device Contaminated at the User Facility1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, DURING PATIENT INDWELLING, THE BALLOON BURST AND FELL OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19822785 ↗MalfunctionJul 24, 2024Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping
ACCORDING TO THE AVAILABLE INFORMATION UPON OPENING THE SECONDARY PACKAGING, A HAIR WAS NOTICED IN THE CATHETER'S PRIMARY PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19816458 ↗MalfunctionJun 21, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BLADDER CATHETER WAS FOUND OUT OF THE BLADDER. A BIG TEAR IN THE BALLOON WAS FOUND. A NEW BLADDER WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19584697 ↗MalfunctionJan 8, 2024Device Contaminated at the User Facility; Device Contaminated at the User Facility
ACCORDING TO THE AVAILABLE INFORMATION A HAIR WAS FOUND IN THE SEALED PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18464423 ↗MalfunctionAug 23, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17607440 ↗MalfunctionAug 23, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17605727 ↗MalfunctionAug 23, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17605650 ↗MalfunctionAug 22, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17600138 ↗MalfunctionJun 8, 2023Separation Problem; Separation Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO SEPARATION. THE TIP SEPARATED FROM THE DEVICE WHEN IT WAS OPENED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17090426 ↗
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- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- 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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