Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 947316Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741024931), received between Oct 4, 2021 and Jul 23, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Invagination” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 25, 2026Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗