Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 907316Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741033063), received between Sep 11, 2018 and Feb 12, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 reports).

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.

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.

• 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 ↗
• 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 ↗