Davol® Female Cath Kit 0035380Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741045820), received between Jul 17, 2017 and Jan 28, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Disconnection

  IT WAS REPORTED THAT THE SPECIMEN CATHETER OF THE FEMALE EXTERNAL CATHETER CAME UNATTACHED FROM THE SPECIMEN CONTAINER. THE CATHETER HAD TO BE RETRIEVED THE PATIENTS URETHRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206302 ↗
• MalfunctionJan 28, 2026Disconnection

  IT WAS REPORTED THAT THE PLASTIC CATHETER PART WAS NOT STAYING IN THE SPECIMEN CONTAINER, AND THEY ACTUALLY HAD TO PULL OUT THE SMALL PLASTIC CATHETER PART FROM THE URETHRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206105 ↗
• MalfunctionDec 24, 2025Disconnection; Disconnection; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FEMALE CATHETER THAT GOES INTO THE PATIENT WAS VERY LOOSE/SLIDING OUT OF THE HOLDER INSERTING OR GOING BACK INTO THE HOLDER INSTEAD OF INTO THE PATIENT. CLINIC HAD 2 LIKE THIS BUT MANAGED TO HOLD THEM IN ORDER TO USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889046 ↗
• MalfunctionAug 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT GETTING MULTIPLE REPORTS FROM EMERGENCY ROOM ABOUT BENT AND CRIMPING TUBING ON OUR FEMALE CATHETER KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772225 ↗
• MalfunctionJun 10, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER TUBE IN THE FEMALE STRAIGHT CATHETER KIT SNAPPED IN HALF WHEN TRYING TO PULL THE CATHETER FURTHER OUT OF THE COLLECTION TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498671 ↗
• InjuryDec 22, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT HOW MUCH OF THE FOLEY CATHETER SHOULD BE LEFT IN THE TUBE WHEN USING IT TO OBTAIN A URINE SPECIMEN. AND REPORTED THAT THE INTERMITTENT CATHETER SOMETIMES A SMALLER SIZE COULD BE USED DUE TO IT JUST BEING FOR SPECIMEN COLLECTION. THE POSSIBLE LEAKING AROUND THE CATHETER WAS NOT AS GREAT OF A CONCERN IF NOT BEING PLACED AS AN INDWELLING. AND REPORTED THAT 5 FRENCH CATHETER KITS WERE VERY SECURE IN THE COLLECTION TUBE. AND SOME RESISTANCE WHEN PULLING OUT THE CATHETER, WHILE THE 8 FRENCH FEMALE CATHETER KITS HAD VERY LITTLE RESISTANCE WHEN PULLING OUT THE CATHETER. IT DID NOT FALL OUT ON ITS OWN BUT TOOK VERY LITTLE PULL TO HAVE IT BECOME COMPLETELY DISLODGED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 19JAN2024, THEY DID NOT HAVE THE LOT NUMBERS FOR THE DEVICES AT CELEBRATION WHERE THE PRODUCT THAT LEAD TO PATIENT HARM WAS USED. BUT THE PRODUCT THAT THEY REVIEWED AND EXPERIENCED EASY MOVEMENT OF THE CATHETER WITHIN THE COLLECTION TUBE WAS NGHN0341. MULTIPLE DIFFERENT LOT NUMBER OF THE INTERMITTENT 8 FRENCH CATH KIT HAVE BEEN LOOKED AT BETWEEN TWO CAMPUSES. THE SAME CONCERN WAS VOICED WITH THE EASE OF MOVEMENT WITH THE 8 FRENCH CATH WITHIN COLLECTION TUBE FO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382951 ↗
• InjuryNov 17, 2023Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT CATHETER IN THE FEMALE CATHETER KIT BECAME DISLODGED FROM COLLECTION DEVICE WHEN REGISTER NURSE WAS INSERTING IT AND CATHETER ITSELF WAS STUCK IN URINARY MEATUS. WHEN COMPARED AFTER TO SIMILAR PRODUCTS, THE OTHER CATHETERS WERE MUCH MORE SECURE IN COLLECTION DEVICE AND HARDER TO REMOVE. WHEN THE NURSES WERE OBTAINING URINE VIA STRAIGHT CATHETER, THE URINE COLLECTION KIT CAME APART, AND THE CATHETER PORTION DISLODGED AND BECAME STUCK IN THE PATIENT. THE PROVIDER STAFF WAS UNABLE TO REMOVE THE CATHETER, AND THE CHILD WAS SENT TO THE OPERATING ROOM FOR UROLOGY TO REMOVE. THE CHILDREN EMERGENCY CENTER HAD 2 TYPES OF STRAIGHT CATHETER KITS. UPON EXAMINATION, THE TYPE OF KIT USED IN THIS CASE EASILY FELL APART, UNLIKE THE OTHER KIT THEY CARRY. THEY WERE REMOVED FROM THE UNIT TO PREVENT FURTHER ISSUES. PER ADDITIONAL CLINICAL INFORMATION RECEIVED VIA EMAIL ON 01NOV2023, THE NURSE MANAGER REPORTED THAT THE CATHETER DEVICE WAS BEING USED ON AN 8-YEAR-OLD MALE PATIENT WITH CHRONIC MEDICAL CONDITIONS EXPERIENCING LETHARGY, AND THERE WERE CONCERNS FOR URINARY TRACT INFECTION/SEPSIS. PRIOR TO USE, THERE WERE NO DEVICE ISSUES NOTED. DURING INSERTION, THE CATHETER PORTION OF

  Patient problems: Foreign Body In Patient

  MAUDE report 18159009 ↗
• MalfunctionMar 21, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT CATHETER IN THE FEMALE STRAIGHT CATHETER KIT WAS VERY LOOSE INSIDE OF CAP. CATHETER USED TO BE HELD IN PLACE INSIDE CAP WHICH WOULD ALLOW IT TO BE PULLED FORWARD BUT WOULD PREVENT IT FROM SLIDING BACK IN TUBE OR FALLING OUT. STATED THAT THE DANGER WAS THAT THE CATHETER COULD BE ADVANCED TO FAR FORWARD INTO THE URETHRA AND BECOME DIFFICULT TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584468 ↗
• MalfunctionSep 2, 2022Disconnection; Component Misassembled; Disconnection; Component Misassembled

  IT WAS REPORTED THAT DAVOL FEMALE CATHETER KIT WAS FALLING OUT OF COLLECTION TUBE INTO PATIENT, FREQUENTLY THUS CAUSING THEM TO HAVE TO FISH OUT THE TUBING FROM THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29-AUG-2022, THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347707 ↗
• MalfunctionJan 27, 2020Component Missing

  IT WAS REPORTED THAT THE FEMALE CATHETER KIT WAS MISSING THE SWABS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9633610 ↗
• MalfunctionOct 29, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE CATHETER WAS RIGID CAUSING URETHRAL TRAUMA DURING INSERTION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9252087 ↗
• MalfunctionFeb 25, 2019Component Missing

  IT WAS REPORTED THAT THE KIT WAS MISSING THE IODINE SWABS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367633 ↗
• MalfunctionSep 10, 2018Break; Material Split, Cut or Torn; Break

  IT WAS REPORTED THAT THE FEMALE CATHETER KIT WAS CAUGHT ON THE PACKING TAPE FOR THE OUTER CARDBOARD BOX RESULTING IN A TEAR FORM THE STERILE PACKAGING AND A RIP.

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

  MAUDE report 7860651 ↗
• MalfunctionOct 30, 2017No Flow

  IT WAS REPORTED THAT THE CATHETER WAS NOT DRAINING URINE AFTER INSERTION IN THE CORRECT ANATOMICAL PLACEMENT. IT WAS NOTED THAT ANOTHER CATHETER WAS INSERTED AND DRAINED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6988615 ↗
• MalfunctionSep 19, 2017Leak/Splash

  IT WAS REPORTED THAT THE POVIDONE-IODINE LEAKED INSIDE THE PACKAGING.

  Patient problems: No Information

  MAUDE report 6875227 ↗
• MalfunctionJul 26, 2017Hole In Material

  IT WAS REPORTED THAT THE FEMALE CATHETER KIT CONTAINED DAMAGED GLOVES. THE GLOVES HAD HOLES IN THEM.

  Patient problems: No Information

  MAUDE report 6745614 ↗
• MalfunctionJul 25, 2017Hole In Material; Material Integrity Problem

  IT WAS REPORTED THAT THE GLOVES IN THE FEMALE CATHETER KIT HAD HOLES IN THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6742806 ↗
• MalfunctionJul 25, 2017Hole In Material

  IT WAS REPORTED THAT THE GLOVES IN THE KIT HAD HOLES IN THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6742793 ↗
• MalfunctionJul 17, 2017No Flow

  IT WAS REPORTED THAT AFTER INSERTION, THE CATHETER WOULD NOT DRAIN URINE. THE CATHETER WAS REMOVED, A NEW CATHETER WAS INSERTED, AND URINE THEN DRAINED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6719738 ↗