Bard® Silastic® Foley Catheter 33422Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741020018), received between Apr 21, 2017 and Jun 8, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. Apr 23, 2026Open, Classified

   Due to stain present on the surface of affected foley catheters.

   Z-2226-2026 · Root cause: Material/Component Contamination · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE FOLEYS HE RECEIVED IN THIS ORDER WERE DAMAGED, CAUSING LEAKAGE. HE ALREADY USED 2 OUT OF THE 3. SENT AN EMAIL TO HAVE CUSTOMER SERVICE CALL BACK. NO ADDITIONAL INFORMATION PROVIDED. IT'S UNCLEAR IF TROUBLESHOOTING WAS PROVIDED. (PREPPING AND PLACEMENT TIPS SHARED)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437691 ↗
• InjuryMar 18, 2026Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER BEEN REPORTED AS DEFECTIVE, ACCORDING TO THE PATIENT THE BALLOON BURST INSIDE AND HAS TO BE HOSPITALIZED FOR 5 MONTHS, ANOTHER INSTANCE WAS THE BALLOON WAS LEFT INSIDE. THEY SEEK MEDICAL ATTENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24628320 ↗
• MalfunctionSep 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PT SAID THAT THE BALLOON WAS NOT EXPANDING. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038325 ↗
• MalfunctionJun 30, 2025Collapse; Collapse

  IT WAS REPORTED BY THE CUSTOMER THAT THE FOLEY #5733422, LOT#NGJP2382 KEPT COLLAPSING AND THE URINE BACKS UP AND SPILLS OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358117 ↗
• MalfunctionAug 11, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER HAD MULTIPLE ISSUES WITH THE FOLEY CATHETER BALLOON. THE BALLOON HAD BURST INSIDE THE PATIENT SEVERAL TIMES. THE BALLOON ALSO DID NOT BLOW UP ON SOME OCCASIONS. THE BALLOON WAS ALSO LEAKING. THIS HAD HAPPENED WITH ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510636 ↗
• MalfunctionAug 11, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE CUSTOMER HAD MULTIPLE ISSUES WITH THE FOLEY CATHETER BALLOON. THE BALLOON HAD BURST INSIDE THE PATIENT SEVERAL TIMES. THE BALLOON ALSO DID NOT BLOW UP ON SOME OCCASIONS. THE BALLOON WAS ALSO LEAKING. THIS HAD HAPPENED WITH ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509033 ↗
• MalfunctionAug 10, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CUSTOMER HAD MULTIPLE ISSUES WITH THE FOLEY CATHETER BALLOON. THE BALLOON HAD BURST INSIDE THE PATIENT SEVERAL TIMES. THE BALLOON ALSO DID NOT BLOW UP ON SOME OCCASIONS . THE BALLOON WAS ALSO LEAKING. THIS HAD HAPPENED WITH ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497363 ↗
• MalfunctionNov 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD URINE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10793598 ↗
• MalfunctionOct 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A BYPASS ISSUE. SUPPOSEDLY THE LUBRICATH WAS SUBSTITUTED FOR THE SAME FRENCH OF BALLOON SIZE AS ORIGINALLY RECEIVED HOWEVER THERE WAS STILL URINATING THROUGH THE BYPASS. THE PATIENT HAD A SIGNIFICANT ENLARGED PROSTATE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A PROSTATE CANCER AND THE INSERTION ISSUES MIGHT BE RELATED TO THIS. THE MEDICAL INFORMATION LEAD ADDED THAT IN THE PATIENT EXPERIENCE. THE BYPASS WAS COMMONLY RELATED TO BLADDER SPASMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10734325 ↗
• InjuryJan 3, 2020Deflation Problem; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE SILASTIC FOLEY CATHETER WAS DIFFICULT TO REMOVE AND WAS GETTING STUCK IN THE URINARY TRACT. ONE PATIENT REPORTEDLY HAD TO HAVE THE CATHETER REMOVED IN INTERVENTIONAL RADIOLOGY. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT VIA EMAIL ON 10JAN2020, IT WAS NOTE THAT THE PATIENT REQUIRED CT GUIDED PUNCTURE OF THE BALLOON THROUGH THE ABDOMEN.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 9544562 ↗
• MalfunctionApr 21, 2017Crack

  IT WAS REPORTED THAT THE RUBBER WAS CRACKING AROUND THE MALE END THAT CONNECTS TO THE URINARY BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6512251 ↗