Bard® Silastic® Foley Catheter 33622Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741020094), received between May 31, 2018 and Jun 25, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 23, 2026Class IIOpen, Classified

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

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Wrong Label; Wrong Label

  AUTH SAID THE CATHETERS THE PATIENT RECEIVED 24FR SIZE IN 22FR PACKAGING. AUTH WAS UNABLE TO USE CATHETERS AS THEY WERE THE WRONG SIZE. PATIENT ORDERS THROUGH BYRAM. PATIENT HAS 4 ORDERS TO RETURN (ORDER #: (B)(6); NO ADDITIONAL INFORMATION WAS PROVIDED NOR WAS THERE ANY PATIENT IMPACT OF MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330934 ↗
• MalfunctionMar 31, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER STATED THAT THE EYELETS OR LITTLE HOLES WERE CLOSED FOR ITEM OF FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730759 ↗
• MalfunctionJan 23, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE BALLOON OF FOLEY CATHETER KEPT DEFLATING BY 3MM WHICH CAUSED BYPASSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562194 ↗
• MalfunctionDec 14, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DEFECTIVE, THE BALLOON WOULD NOT INFLATE AND DEPLOYED. WHEN THEY TRIED TO, IT LEAKED ON TOP OF THE VALVE. PER FOLLOW UP VIA PHONE ON 14DEC2022, STATED THAT NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982873 ↗
• MalfunctionJan 29, 2019Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT INFLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285295 ↗
• MalfunctionAug 7, 2018Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER WOULD NOT INFLATE. THE PATIENT HAD HIS CATHETER REPLACED BY HIS DOCTOR. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7756230 ↗
• MalfunctionMay 31, 2018Leak/Splash

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING URINE CLOSE TO THE CAP AFTER LESS THAN 12 HOURS OF USE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7558998 ↗