SureStep™ Foley Tray System Lubri-Sil® Temperature Sensing Foley Catheter A909216MRecalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Lubri-Sil® Temperature Sensing Foley Catheter Tray 350 ml Urine Meter · Class 2
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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741104763), received between Oct 17, 2018 and Oct 30, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Component Missing1
- Deflation Problem1
- Device Fell1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE 3 FOAM SWABS LISTED ON THE CONTENTS WERE NOT PRESENT IN THE SURESTEP FOLEY TRAY SYSTEM UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427499 ↗MalfunctionAug 21, 2019Deflation Problem; Device Fell
IT WAS REPORTED THAT ONE SURESTEP FOLEY TRAY WAS RECEIVED WITHOUT THE IODINE SWAB STICKS, AND THAT THE CATHETER IN ANOTHER SURESTEP FOLEY TRAY PREMATURELY DEFLATED AND FELL OUT OF THE PATIENT. THEREFORE, THE CATHETER WAS REPLACED. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8917157 ↗MalfunctionOct 17, 2018Leak/Splash; Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THE THERE WAS A LEAK AROUND THE FOLEY AT THE MEATUS. NO PATIENT INTERVENTION WAS REQUIRED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7973652 ↗
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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