Bard Foley Tray With Lubri-Sil All-Silicone Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2018 and Feb 25, 2025 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (3 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 25, 2026Class IIOpen, Classified
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Z-3115-2026 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
Most reported Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter problems
Device problems
- Deflation Problem3
- Burst Container or Vessel2
- Component Missing2
- Material Invagination2
- Decrease in Pressure1
- Difficult to Remove1
- Gel Leak1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient4
- No Patient Involvement1
Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 947316CATHETER, RETENTION TYPE, BALLOON1 recall5 reports
- Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 947314CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 947318CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 907316CATHETER, RETENTION TYPE, BALLOON5 reports
- Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 908316CATHETER, RETENTION TYPE, BALLOON2 reports
Recent Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter adverse event reports
The 13 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2025Component Missing; Component Missing
IT WAS REPORTED THAT DURING THE ACTIVITY, A NEW FOLEY TRAY WAS USED FOR THE DEMONSTRATION, BUT WHEN IT WAS OPENED FOR PRACTICAL USE, THE LACK OF THE SYRINGE PREFILLED WITH THE SOLUTION WAS DETECTED, ATTACHED THE DATA OF SAID TRAY. ADDITIONAL INFORMATION RECEIVED ON 10FEB2025, THAT IT WAS DURING A TRAINING, THE KIT WAS OPENED IN WHICH THE MISSING SYRINGE WAS DETECTED WITH STERILE WATER. THE PREFILLED SYRINGE WAS NOT AVAILABLE, THAT'S WHY IT WAS NOT POSSIBLE TO KNOW THE DETAIL OF THE MATERIAL AND BATCH SINCE IT WAS A COMPONENT OF THE KIT. THE DATE OF THE EVENT WAS (B)(6) 2025. PER FOLLOW UP INFORMATION RECEIVED ON 18FEB2025, THEY CONFIRMED THE INVOLVEMENT OF THE NURSING STAFF WHO WERE INVOLVED WHEN THIS EVENT OCCURRED, AS IT WAS DURING A TRAINING WITH NEW STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21459284 ↗MalfunctionJul 23, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT SYRINGE IN FOLEY TRAY WAS SMASHED (PCN#947316). DRAIN BAG OPENING WHERE THE TIP FOR EMPTYING SITS WAS ALL SMASHED WHICH ALLOWED URINE TO LEAK ALL OVER THE OPERATING ROOM FLOOR (PCN#154002). FIRST ONE THE FOLEY CATHETER BALLOON POPPED (PCN#175816) AND THE SECOND TRY, THE BALLOON LEAKED (PCN#175816). PER FOLLOW UP RESPONSE VIA EMAIL ON 16JUL2024, CUSTOMER STATED THAT THEY WERE ALL THE SAME LOT#NGHZ3646. NO ADDITIONAL PATIENT IMPACT FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19805825 ↗MalfunctionNov 17, 2023Gel Leak; Nonstandard Device; Gel Leak; Nonstandard Device
IT WAS REPORTED THAT THE INSIDE THIS PRODUCT COMES AN ACCESSORY, CALLED URINARY CATHETER LUBRICATION GEL. THIS ACCESSORY WAS CHEMICALLY CHANGED, THAT IS, THE CLIENT INDICATES THAT IT CAME DRY INSIDE THE PACKAGING, FOR THIS REASON IT COULD NOT BE USED, THAT IS, THIS LUBRICANT WAS USED SO THAT THE URINARY CATHETER PASSES THROUGH THE URINARY MEATUS WITHOUT RESISTANCE AND MORE SOFT. IT WAS STATED THAT NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18159736 ↗MalfunctionMar 24, 2022Material Invagination; Material Invagination
IT WAS REPORTED THAT UPON DEFLATING THE BALLOON, IF THERE WAS ANY PRESSURE BETWEEN THE BALLOON AND THE BLADDER WALL, A RIDGE GETS FORMED ON THE SILICONE CATHETER PREVENTING THE CATHETER FROM BEING REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13897184 ↗MalfunctionNov 18, 2021Material Invagination; Material Invagination
IT WAS REPORTED THAT UPON REMOVING THE FOLEY CATHETER, THE BALLOON WAS DEFLATED BUT IF THERE WAS ANY PRESSURE AGAINST THE BALLOON DURING THIS STEP, A FOLD WILL OCCUR IN THE SILICONE CIRCUMFERENTIALLY. THIS PREVENTED THE FOLEY CATHETER FROM BEING REMOVED. THIS HAD HAPPENED MULTIPLE TIMES WITH BOTH THE TRAY PRODUCT NUMBER 897216 AND WITH TRAY PRODUCT NUMBER 947316. AND ONE PATIENT NEEDED TO GO TO HAVE A PROCEDURE TO REMOVE THE CATHETER. THE CUSTOMER STATED THAT THEY HAVE A LARGE NUMBER OF THESE FOLEY TRAYS THAT WERE NOT WORKING FOR THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12836629 ↗MalfunctionOct 4, 2021Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT TWO SILICONE FOLEY CATHETER BALLOON WERE POPPED. PER FOLLOW UP RECEIVED VIA EMAIL ON (B)(6) 2021, CUSTOMER STATED THAT THE BALLOON WAS NOT INFLATED PRIOR TO INSERTION ON ANY OF THE FOLEY CATHETERS AND THE INCIDENT HAPPENED AT THE TIME OF INSERTION WHEN THE NURSE INJECTED 10CC OF FLUID INTO THE BALLOON. THE NURSE DISCARDED BOTH FAILED FOLEYS AS THEY WERE INSIDE THE PATIENT AT THE TIME OF FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12568172 ↗MalfunctionFeb 12, 2021Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE FOLEY CATHETER KEPT FALLING OUT. THE USER INQUIRED ABOUT FILLING THE BALLOON WITH MORE THAN 10 CC OF WATER. MSS ADVISED THAT BD DID NOT RECOMMEND OVER OR UNDER INFLATING AS THIS COULD RESULT IN ASYMMETRICAL BALLOONS WHICH COULD DEFLECT THE CATHETER TIP TO ONE SIDE. ALSO ADVISED THAT THE DEFLATION COULD CAUSE THE OCCLUSION OF DRAINAGE EYES IRRITATE THE BLADDER WALL AND POTENTIALLY LEAD TO BLADDER SPASMS. MSS STATED THAT THE INFLATION GUIDELINES WERE ATTACHED AS A REFERENCE AND SUGGESTED VERIFYING THE CATHETER POSITIONING AND OFFERED THE CATHETER WITH 30 CC BALLOON AS AN OPTION.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11322391 ↗MalfunctionNov 19, 2020Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER WHICH WAS INFLATED IN THE MALE PATIENT WAS LEAKED DUE TO A HOLE IN THE BALLOON AND THE CATHETER FELL OUT . A SECOND CATHETER WAS INSERTED AND INFLATED PRIOR TO INSERTION. AFTER INSERTION A POPPING SOUND WAS NOTED AND THE CATHETER WAS FELL OUT. ALSO, REPORTED THAT THE THIRD ATTEMPT OF THE FOLEY CATHETER WAS UNSUCCESSFUL DUE TO THE CATHETER WAS UNABLE TO PASS THROUGH THE PROSTATE. PER FOLLOW-UP VIA EMAIL ON 29OCT2020, THERE WAS NO IMPACT TO THE PATIENT. IT WAS NOTED THAT THERE WAS NO FURTHER FOLEY CATHETER WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10868903 ↗MalfunctionNov 19, 2020Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE FOLEY CATHETER WHICH WAS INFLATED IN THE MALE PATIENT WAS LEAKED DUE TO A HOLE IN THE BALLOON AND THE CATHETER FELL OUT. A SECOND CATHETER WAS INSERTED AND INFLATED PRIOR TO INSERTION. AFTER INSERTION A POPPING SOUND WAS NOTED AND THE CATHETER WAS FELL OUT. ALSO, REPORTED THAT THE THIRD ATTEMPT OF THE FOLEY CATHETER WAS UNSUCCESSFUL DUE TO THE CATHETER WAS UNABLE TO PASS THROUGH THE PROSTATE. PER FOLLOW-UP VIA EMAIL ON 29OCT2020, THERE WAS NO IMPACT TO THE PATIENT. IT WAS NOTED THAT THERE WAS NO FURTHER FOLEY CATHETER WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10868817 ↗MalfunctionAug 23, 2019Deflation Problem; Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO DEFLATE. REPORTEDLY, IT TOOK 4 ATTEMPTS BY THE NURSING STAFF BEFORE THE BALLOON WOULD DEFLATE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8925056 ↗MalfunctionOct 18, 2018Component Missing
IT WAS REPORTED THAT THE POVIDONE-IODINE WAS MISSING FROM THE TRAY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7980420 ↗MalfunctionSep 19, 2018Deflation Problem; Inflation Problem; Deflation Problem
IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETERS WOULD NOT STAY INFLATED INSIDE OF THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7890366 ↗MalfunctionSep 11, 2018Deflation Problem
IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER DEFLATED PREMATURELY. NO MEDICAL INTERVENTION WAS NECESSARY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7865661 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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