Bard® Clean-Cath® Intermittent Catheter 421716Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741038839), received between May 3, 2017 and Jun 28, 2021 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE VINYL CLEAN CATHETERS WERE TOO BIG AND DIFFICULT TO INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081417 ↗
• MalfunctionJul 28, 2020Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement

  IT WAS REPORTED THAT THE SOME OF THE VINYL CATHETERS WERE TOO BIG AND PATIENT WAS UNABLE TO USE THEM.

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

  MAUDE report 10333629 ↗
• MalfunctionJul 6, 2020Component Missing; Component Missing; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE CATHETER BOX HAD ONLY 12 CATHETER OUT OF 50.

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

  MAUDE report 10232687 ↗
• InjuryDec 26, 2019Break; Entrapment of Device

  IT WAS REPORTED THAT THE TIP OF THE CATHETER BROKE OFF INSIDE OF THE PATIENT. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM WHERE AN X-RAY AND A PROBE WERE PERFORMED, HOWEVER, THE TIP OF THE CATHETER COULD NOT BE LOCATED OR RETRIEVED. THE PATIENT HAD TO SCHEDULE A PENDING APPOINTMENT TO FOLLOW UP WITH THE UROLOGIST IN A WEEK.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 9521685 ↗
• MalfunctionOct 16, 2019Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WERE PRICKLY SPURS ON THE TIP OF THE CATHETER CAUSING DISCOMFORT DURING THE INSERTION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 9198949 ↗
• MalfunctionAug 28, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE EYELETS WERE TOO SMALL AND NOT "POLISHED" CAUSING BLEEDING.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8941878 ↗
• MalfunctionAug 28, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE EYELETS WERE TOO SMALL AND NOT "POLISHED" CAUSING BLEEDING.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8941786 ↗
• MalfunctionJul 3, 2019Component Missing

  IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO CATH WITH A CLEAN CATH VINYL CATHETER. HE DISCOVERED THAT ALTHOUGH THE PACKAGE WAS SEALED CLOSED, THERE WAS NO CATHETER IN THE PACKAGE.

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

  MAUDE report 8757456 ↗
• MalfunctionJun 17, 2019Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETERS WERE BENT IN THE PACKAGING MAKING THEM DIFFICULT TO INSERT.

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

  MAUDE report 8705085 ↗
• MalfunctionJun 4, 2019Device Damaged Prior to Use; Device Damaged Prior to Use; Scratched Material

  IT WAS REPORTED THAT THE CATHETER HAD SHARP EDGES AND CAUSED THE PATIENT SOME BLEEDING AND DISCOMFORT DURING INSERTION. THE PATIENT WAS NOT ABLE TO FULLY INSERT THE CATHETER FOR USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8669276 ↗
• MalfunctionMay 7, 2019Break; Component Missing; Detachment of Device or Device Component; Scratched Material

  IT WAS REPORTED THAT APPROXIMATELY 1/16 OF THE TIP OF CLEAN CATH VINYL CATHETER WAS JAGGED AND BROKEN OFF. REPORTEDLY, THE PATIENT DID NOT REALIZE THAT THE TIP HAD BROKEN OFF UNTIL HE EXAMINED THE CATHETER UPON REMOVAL AFTER A PAINFUL INSERTION ATTEMPT. AS A RESULT, THE PATIENT EXPERIENCED SELF-LIMITED BLEEDING. WHEN THE PATIENT ATTEMPTED TO CATH WITH A SECOND CLEAN CATH VINYL CATHETER, HE DISCOVERED THAT ALTHOUGH, THE PACKAGE WAS SEALED CLOSED THERE WAS NO CATHETER IN THE PACKAGE. THE PATIENT ADVISED THAT HE WILL FOLLOW-UP WITH HIS DOCTOR TO MAKE SURE HE IS CLEAR OF ANY INFECTION.

  Patient problems: Blood Loss; Pain; Patient Problem/Medical Problem

  MAUDE report 8586017 ↗
• InjuryJul 24, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED AN URINARY TRACT INFECTION FOLLOWING USE OF THE CATHETER. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 7713495 ↗
• MalfunctionNov 26, 2017Cut In Material

  IT WAS REPORTED THAT PRIOR TO USE, THE TIP OF THE CATHETER WAS CUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7058340 ↗
• MalfunctionMay 3, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SURGEON WAS NOT HAPPY WITH THE REPLACEMENT PRODUCT, AS THE PRODUCT ALLEGEDLY DID NOT DRAIN WELL, ESPECIALLY FOR MALES. THE UROLOGIST ALLEGED THAT THE SILICONE WAS NOT AS SMOOTH AS THE RED RUBBER; THEREFORE, DID NOT SLIDE WELL. ONE OF THE ANAESTHETISTS USED THIS CATHETER AS AN INTRA- NASAL GUIDE FOR PEDIATRIC PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6540710 ↗