SureStep Foley Tray System with Bard Lubri-Sil CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one SureStep Foley Tray System with Bard Lubri-Sil Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of SureStep Foley Tray System with Bard Lubri-Sil Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2018 and Feb 25, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (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
SureStep Foley Tray System with Bard Lubri-Sil 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 4 of these models · Recall details · FDA record ↗
Most reported SureStep Foley Tray System with Bard Lubri-Sil Catheter problems
Device problems
- Material Puncture/Hole3
- Material Rupture3
- Burst Container or Vessel2
- Difficult to Remove2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient2
SureStep Foley Tray System with Bard Lubri-Sil Catheter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SureStep™ Foley Tray System with Bard® Lubri-Sil® Catheter A942206CATHETER, RETENTION TYPE, BALLOON1 recall6 reports
- SureStep™ Foley Tray System with Bard® Lubri-Sil® Catheter A942208CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- SureStep™ Foley Tray System with Bard® Lubri-Sil® Catheter A942212CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- SureStep™ Foley Tray System with Bard® Lubri-Sil® Catheter A942210CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
Recent SureStep Foley Tray System with Bard Lubri-Sil Catheter adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Difficult to Remove
IT WAS REPORTED THAT AFTER INSERTING THE FOLEY CATHETER TO THE PATIENT IN THE OPERATING ROOM, WATER COULD NOT BE INFUSED, AND LEAKAGE WAS CONFIRMED FROM THE VALVE, SO REMOVAL WAS DECIDED. THEN TRIED TO WITHDRAW WATER USING A SYRINGE, BUT IT COULD NOT BE DRAWN AT ALL. THE CATHETER WAS REMOVED, LEAVING A SMALL AMOUNT OF STERILE WATER REMAINING. NO BLEEDING OR OTHER ISSUES WERE OBSERVED. THE TROUBLESHOOTING PROCEDURE IN THE NOTICE DOCUMENT WAS TRIED AND STILL NOT ABLE TO WITHDRAW WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24446108 ↗MalfunctionAug 12, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT THE CUSTOMER STATED THEY HAD A BALLOON RUPTURE OF THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22785336 ↗MalfunctionApr 30, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT CUSTOMER HAD INCIDENT ON (B)(6) 2024 WITH FOLEY CATHETER WITH PENDING INFORMATION AND ON (B)(6) 2024, FOLEY CATHETER WAS INSERTED ON A PATIENT, UPON INFLATING THE BALLOON TO THE PRESCRIBED 1.5 ML, THEY GENTLY TUGGED TO ENSURE PATENCY, BUT THE ENTIRE CATHETER CAME OUT OF THE PATIENT, AND THE BALLOON WAS NOT INFLATED AT ALL. THEY INSPECTED THE FOLEY BALLOON BY INJECTING MORE FLUID AND NOTICED THAT THE FLUID WAS LEAKING FROM THE BALLOON AREA. ANOTHER FOLEY OF THE SAME SIZE WAS INSERTED. MD AND ANESTHESIA, AND SUPERVISOR AWARE OF THE INCIDENT AND THERE WAS THIRD INCIDENT WITH PENDING INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212536 ↗MalfunctionFeb 6, 2024Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE 6 FR FOLEY CATHETER WAS USED IN PATIENT. WHILE CARING FOR PATIENT, THE CATHETER HAD COME OUT AND NOTED THAT THE BALLOON WAS POPPED/NOT INTACT. NEW FOLEY CATHETER HAD TO BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18649274 ↗MalfunctionDec 7, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE BALLOON OF TEMPERATURE SENSING FOLEY CATHETER FAILED TO DEFLATE AFTER THE BALLOON CHECKED PRIOR TO INSERTION. WE HAVE TWO SEPARATE SAMPLES SEQUESTERED PENDING RECEIPT OF RETURN KITS: 1. YNHHS TRACKER # 3396 ¿ BD PRODUCT #A942206 TRAY CATHETER URINE FOLEY SURESTEP 6FR ¿ COMPLAINT SUBMITTED NOV 6, 2023. 2. YNHHS TRACKER # 3403 ¿ BD PRODUCT #A319516AM TRAY FOLEY URINE METER TEMP SENSING 16FR X 5CC ¿ COMPLAINT SUBMITTED NOV 6, 2023. PER FOLLOW UP VIA EMAIL ON 15DEC2023, IT WAS REPORTED THAT THE SAMPLE WAS SENT BACK FOR EVALUATION ON 13DEC2023. THE PRODUCT ISSUE WAS OBSERVED PRIOR TO INSERTION AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18282256 ↗MalfunctionNov 27, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE CUSTOMER WAS CONCERNING AN EVENT WHILE USING A BARD PRODUCT FOLEY TRAY. THE LOT NUMBER WAS UNKNOWN. NO HARM TO THE PATIENT HAD BEEN REPORTED. THE EVENT DATE WAS 25OCT2023. THEY HAD ONE EACH OF THE DEFECTIVE SAMPLE AVAILABLE TO RETURN FOR ANALYSIS. THE CLINICIANS DESCRIBE THE COMPLAINT, FOLEY CATHETER IN PATIENT, WHILE CARING FOR PATIENT FOLEY HAD COME OUT AND NOTED THAT THE BALLOON WAS POPPED/NOT INTACT. NEW FOLEY CATHETER HAD TO BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18208698 ↗MalfunctionSep 29, 2022Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT WHEN REGISTERED NURSE INSERTED THE FOLEY CATHETER AND INFLATED THE BALLOON, THE FLUID LEAKED OUT OF INSERTION SITE AND THE CATHETER BECAME DISLODGED. STATED THAT WHEN ASSESSED THE PRODUCT REGISTERED NURSE NOTED THAT BALLOON HAD A LEAK. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16SEP2022, STATED THAT THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15504811 ↗MalfunctionSep 24, 2019Material Rupture
WHILE PREPARING PT. FOR PROCEDURE AN 8FR FOLEY CATHETER (REF: A942208, LOT: NGDQ3696) WAS INSERTED. STERILE TECHNIQUE WAS MAINTAINED WHEN INSERTING THE FOLEY CATHETER. AFTER VERIFYING THE BALLOON PORT SIZE (5ML) THE CIRCULATOR INJECTED 5ML OF STERILE WATER INTO THE BALLOON PORT. IT WAS NOTED THERE WAS NO RESISTANCE AND AFTER VERIFYING PLACEMENT (URINE WAS EMPTYING INTO THE FOLEY CONTAINER) THE FOLEY CATHETER CAME ALL THE WAY OUT WITH BALLOON DEFLATED AND STERILE WATER COMING OUT OF THE BALLOON. THE FOLEY CATHETER AND STERILE FIELD WERE TAKEN DOWN AND THROWN OUT. A NEW 8 FR. FOLEY CATHETER WAS PLACED WITH NO COMPLICATIONS. PACKAGING WAS KEPT BY CIRCULATOR AND CLINICIAN WAS NOTIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9109222 ↗MalfunctionOct 31, 2018Fluid/Blood Leak
AFTER A FOLEY WAS PLACED, NURSING NOTED LATER THAT NIGHT THAT THE CLEAR AIR PORT OF THE FOLEY WAS LEAKING. THE RED SEAL WAS THEN REMOVED AND NEW TUBING WAS ATTACHED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8023575 ↗
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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