SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A307416ARecalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Lubri-Sil® IC Complete Care® Coude Catheter Tray & 350 ml Urine Meter · Class 2
All models of SureStep Foley Tray System Lubri-Sil IC Complete Care (14)
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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741104381), received between Jun 24, 2024 and Sep 15, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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
- 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
- Material Rupture2
- Material Puncture/Hole1
- Short Fill1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Material Puncture/Hole; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781538 ↗MalfunctionApr 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT COUDE FOLEY CATHETER CAME OUT OF PATIENT. SECOND FOLEY TO COME OUT OF PATIENT. UPON INSPECTING, BALLOON ON BOTH APPEARED TO HAVE RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21858916 ↗MalfunctionMar 28, 2025
COUDE FOLEY CAME OUT OF PATIENT. SECOND FOLEY TO COME OUT OF PATIENT. UPON INSPECTING, BALLOON ON BOTH APPEARED TO HAVE RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21718124 ↗MalfunctionJun 24, 2024Short Fill; Short Fill
IT WAS REPORTED THAT STERILE WATER SYRINGE WAS FOUND EMPTY IN THE FOLEY TRAY. PER FOLLOW UP VIA PHONE ON (B)(6) 2024, CUSTOMER PROVIDED LOT#NGJN0574 AND STATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT, AND THEY NO LONGER HAVE THE SYRINGE, IT WAS THROWN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593622 ↗
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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