Personal Catheter™ Intermittent Catheter 63614Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741069291), received between Apr 7, 2017 and Sep 23, 2026 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (17 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873306 ↗
• MalfunctionSep 17, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT, THE HOLES IN THE FOLEY CATHETER HAD NOT BEEN CUT OUT PROPERLY. SCRAPES INSIDE THE URETHRA WHEN USING. IT HAD HAPPENED TO AT LEAST 2 OF THEM FROM THE SAME BOX AND CAUSED A LITTLE BLEEDING.

  Patient problems: Abrasion; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23073667 ↗
• MalfunctionApr 4, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED BY THE PATIENT THAT 5 FOLEY CATHETERS FROM ONE BOX HAD VERY LITTLE LUBRICATION ON THEM, AND PATIENT RECEIVED 3 BOXES, ALL THE SAME LOT NUMBER. THE FIRST BOX USED WAS FINE, THERE WAS LACK OF LUBRICATION OF 5 OF THE SECOND BOX USED, PATIENT HAD NOT YET USED THE THIRD BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773888 ↗
• MalfunctionMar 3, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PATIENT ADVISED THAT THE LAST FEW BOXES OF INTERMITTENT CATHETER THEY RECEIVED, THERE WERE ABOUT 5 THAT THEY COULD NOT USE, PATIENT SAID SOMETIMES THEY HAD A KINK IN THEM LOT#JUJU1214, LOT#JUJT9025 AND SOMETIMES THE SACHET HAD NO WATER IN IT LOT#JUJU1214, LOT#JUJT9025. SO, UNABLE TO LUBRICATE IT. PATIENT RECEIVED 5 BOXES FROM LOT NUMBER JUJU1214 AND 5 BOXES OF FROM JUJT9025. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18FEB2025, STATED THAT THE PATIENT DID NOT KNOW HOW MANY BUT THERE WERE ROUGHLY 5 IN EACH BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503974 ↗
• MalfunctionMar 3, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PATIENT ADVISED THAT THE LAST FEW BOXES OF INTERMITTENT CATHETER THEY RECEIVED, THERE WERE ABOUT 5 THAT THEY COULD NOT USE, PATIENT SAID SOMETIMES THEY HAD A KINK IN THEM LOT#JUJU1214, LOT#JUJT9025 AND SOMETIMES THE SACHET HAD NO WATER IN IT LOT#JUJU1214, LOT#JUJT9025. SO, UNABLE TO LUBRICATE IT. PATIENT RECEIVED 5 BOXES FROM LOT NUMBER JUJU1214 AND 5 BOXES OF FROM JUJT9025. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18FEB2025, STATED THAT THE PATIENT DID NOT KNOW HOW MANY BUT THERE WERE ROUGHLY 5 IN EACH BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503973 ↗
• MalfunctionOct 22, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT PATIENT FOUND THIS BATCH WAS DIFFICULT TO USE. PATIENT HAD SOME PAIN AND DISCOMFORT WHEN USING THE INTERMITTENT CATHETERS, WHICH WAS DUE TO THE LUBRICATION. THE GEL DIDN'T SEEM TO BE COATING THE CATHETER AS IT USUALLY WOULD, WHICH WAS MAKING THE CATHETERS MORE DIFFICULT TO USE. THE CONSISTENCY SEEMS DIFFERENT SOMEHOW. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 20504816 ↗
• MalfunctionDec 23, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A COUPLE CATHETERS IN THE 63614 CATHETER BOX WERE LABELED AS 63616 AND MEASURED 16FR. THE CUSTOMER WAS UNABLE TO USE THESE 2 CATHETERS AS WELL.

  Patient problems: No Patient Involvement

  MAUDE report 11066255 ↗
• MalfunctionNov 11, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE 16 FR CATHETERS WERE PRESENT IN THE 14 FR CATHETER BOX. THE USER NOTED THAT THE PRODUCTS WERE MISLABELED. PER FOLLOW-UP INFORMATION RECEIVED ON 21OCT2020, THE BOX AND THE INDIVIDUAL PACKAGE FOR THE CATHETERS STATED 14 FR, BUT THE DIAMETER OF THE CATHETER WAS MUCH BIGGER THAN 14 FR AS THE CUSTOMER WAS UNABLE TO INSERT DUE TO THE LARGER DIAMETER.

  Patient problems: No Patient Involvement

  MAUDE report 10822433 ↗
• MalfunctionMay 26, 2020Component Misassembled; Positioning Problem; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER STATED THE WATER PACKET WAS NOT CORRECTLY PLACED IN THE CARTON.

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

  MAUDE report 10088084 ↗
• MalfunctionApr 2, 2020Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS WERE FLIMSY, AND LACKED LUBRICITY WHICH CAUSED PAINFUL INSERTION AND REMOVAL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 9917909 ↗
• MalfunctionJan 27, 2020Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS HAVING AN ISSUE INSERTING A STRAIGHT TIP CATHETER INTO THE BLADDER, AND WAS UNABLE TO VOID. THE PATIENT HAD TO GO TO THE ER TO VOID HIS BLADDER. THE HOSPITAL GAVE THE PATIENT A FOLEY CATHETER FOR THE TIME BEING.

  Patient problems: Urinary Retention

  MAUDE report 9634453 ↗
• MalfunctionOct 3, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE LUBRICANT ON THE HYDROPHILIC CATHETERS WERE DRYING OUT WHILE THEY WERE BEING INSERTED.

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

  MAUDE report 9151545 ↗
• MalfunctionJul 10, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT THE WATER PACKET WOULD NOT BURST OPEN. IT WAS LATER REPORTED PER EVALUATION OF THE SAMPLE RECEIVED THAT THERE WAS NO WATER IN THE BURST PACKET.

  Patient problems: No Patient Involvement

  MAUDE report 8776178 ↗
• MalfunctionJul 8, 2019Short Fill; Short Fill; Difficult to Open or Close; Moisture or Humidity Problem

  IT WAS REPORTED THAT THE WATER PACKET WOULD NOT BURST OPEN. PER EVALUATION OF THE SAMPLE RECEIVED, THERE WAS LITTLE TO NO WATER IN THE BURST PACKET.

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

  MAUDE report 8768874 ↗
• MalfunctionFeb 15, 2019Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM THE PACKAGE.

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

  MAUDE report 8342844 ↗
• MalfunctionFeb 15, 2019Short Fill

  IT WAS REPORTED THAT THE BURST PACKETS HAD LITTLE TO NO SOLUTION.

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

  MAUDE report 8342687 ↗
• MalfunctionNov 29, 2018Short Fill; Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH WATER IN THE BURST PACKET TO PROPERLY LUBRICATE THE MAGIC 3 CATHETER. COMPLAINANT REPORTED THAT AS A RESULT OF THIS, THE CATHETER GOT "STUCK" UPON REMOVAL RESULTING IN PAIN AND SELF-LIMITED BLEEDING. THE COMPLAINANT WAS ULTIMATELY ABLE TO REMOVE THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8118479 ↗
• MalfunctionOct 24, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THE WATER PACKET WITHIN THE CATHETER PACKAGE WAS EMPTY.

  Patient problems: No Patient Involvement

  MAUDE report 8002190 ↗
• MalfunctionOct 11, 2018Short Fill

  IT WAS REPORTED THAT THE WATER PACKETS WERE EMPTY. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7956015 ↗
• MalfunctionAug 13, 2018Short Fill; Appropriate Device Problem Term/Code Not Available; Short Fill

  IT WAS REPORTED THAT THE WATER SACHET INCLUDED WITH THE CATHETER WAS NOT FILLED WITH THE PROPER AMOUNT OF WATER.

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

  MAUDE report 7777873 ↗
• MalfunctionJul 24, 2018Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WERE SHARP EDGES ON THE CATHETER WHICH SCRATCHED AND SCRAPED THE URETHRA DURING REMOVAL OF THE CATHETER. THERE WAS SELF-LIMITED BLEEDING THAT OCCURRED HOWEVER; NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7716312 ↗
• MalfunctionJul 24, 2018Product Quality Problem; Short Fill

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH WATER IN THE WATER PACKETS TO LUBRICATE THE MAGIC 3 CATHETER.

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

  MAUDE report 7716129 ↗
• MalfunctionJun 19, 2018Short Fill; Appropriate Device Problem Term/Code Not Available; Short Fill

  IT WAS REPORTED THAT THE WATER PACKETS FOR THE MAGIC 3 CATHETERS WERE EMPTY.

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

  MAUDE report 7614249 ↗
• MalfunctionJun 13, 2018Short Fill; Device Damaged Prior to Use; Defective Component

  IT WAS REPORTED THAT THE WATER PACKET INSIDE THE CATHETER PACKAGING WAS EMPTY.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7598791 ↗
• MalfunctionApr 23, 2018Product Quality Problem; Product Quality Problem; Component Missing

  IT WAS REPORTED THAT THE CATHETER DID NOT LUBRICATE WELL.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7451449 ↗