Porges Coloplast AA6414Recalls & reported problems
Coloplast A/S · FOLYSIL® catheter over the guide CH FR 14 · 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
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03600040129869), received between Dec 21, 2018 and Jan 8, 2024 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel4
- Failure to Deflate2
- Deflation Problem1
- Difficult to Remove1
Patient problems
- No Information3
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2024Failure to Deflate; Failure to Deflate
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON WAS INFLATED BEFORE INSERTION; HOWEVER, THEN THE BALLOON WOULD NOT DEFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18467077 ↗MalfunctionJan 8, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST.
Patient problems: Insufficient Information
MAUDE report 18466093 ↗MalfunctionAug 3, 2023Failure to Deflate; Failure to Deflate
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS DIFFICULT TO DEFLATE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 17451501 ↗MalfunctionOct 27, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON DID NOT COMPLETELY DEFLATE DURING WITHDRAWAL, CREATING A "PLEATED BLISTERING" WHICH INCREASED THE DIAMETER AND ADDED "RELIEFS", MAKING THE WITHDRAWAL DIFFICULT AND PAINFUL FOR THE PATIENT.
Patient problems: Pain
MAUDE report 12705241 ↗MalfunctionMar 7, 2019Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, 2 DAYS AFTER PLACEMENT, CATHETER FELL OFF DUE TO BALLOON BURSTS. DR. CONFIRMED NO RESIDUE OR PARTICLE REMAINS IN PATIENT'S BLADDER . DR. HAS REPLACED WITH NEW PRODUCT IMMEDIATELY, NO CLINICAL CONSEQUENCES REPORTED.
Patient problems: No Information
MAUDE report 8402375 ↗InjuryJan 10, 2019Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, BALLOON FELL OFF DURING INDWELLING DUE TO BALLOON BURST. THE PHYSICIAN REPLACED WITH A NEW CATHETER IMMEDIATELY, NO CLINICAL CONSEQUENCES REPORTED. NO RESIDUE/PARTICLE REMAINS IN PATIENTS BODY.
Patient problems: No Information
MAUDE report 8233304 ↗MalfunctionDec 21, 2018Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, WATER LEAKAGE OBSERVED. DR. CONFIRMED BALLOON BURST, NO RESIDUE OR PARTICLE REMAINS IN PATIENT'S BLADDER, NO CLINICAL CONSEQUENCES REPORTED.
Patient problems: No Information
MAUDE report 8189374 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- 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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