Magic3™ Intermittent Catheter 53612Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00801741068560), received between May 3, 2017 and Jul 1, 2025 — classified as 2 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE CATHETER SNAPPED IN HALF WHERE A CLAMP WAS PLACED. REMOVED IMMEDIATELY, REPLACED WITH 10 FR CATHETER DID NOT OCCUR AGAIN. NO PATIENT WAS AFFECTED/ NO ADVERSE CONSEQUENCES. THE INTERMITTENT CATHETER WAS UNFORTUNATELY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372531 ↗
• MalfunctionMar 19, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE WRONG SUPPLIES OF INTERMITTENT CATHETERS WERE TOO BIG AND CAUSING THE PATIENT TO BLEED. IT WAS ALSO STATED THAT IT DID NOT HAVE A GUIDE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932288 ↗
• MalfunctionMar 19, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE WRONG SUPPLIES OF INTERMITTENT CATHETERS WERE TOO BIG AND CAUSING THE PATIENT TO BLEED. IT WAS ALSO STATED THAT IT DID NOT HAVE A GUIDE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 18928909 ↗
• InjuryJul 28, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER CAUSED AN INJURY TO THE PATIENT¿S URETHRA, AND THEY HAD TO GO TO THE EMERGENCY ROOM ON (B)(6) 2022 AS A RESULT OF THE INJURY AND HAD TO USE A FOLEY CATHETER AS OF RIGHT NOW. THE CATHETER HAD A SHARP EDGE THAT SEEMED TO HAVE BEEN CUT WITH A SCISSOR, BECAUSE THE EDGE WAS NOT ROUND AND SMOOTH LIKE IT WOULD USUALLY BE. IT WAS UNKNOWN WHAT INTERVENTION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15124392 ↗
• MalfunctionSep 17, 2021Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE MALE INTERMITTENT CATHETERS CAME DEFECTIVE, BECAUSE THEY WERE ALL MISSING THE SLEEVE. REPLACEMENT ORDER WAS DONE. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490315 ↗
• MalfunctionJun 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS ONE UNIT LEAKAGE IN THE STERILE WATER BAG FOUND FROM AN INTERMITTENT CATHETER. IT WAS STATED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088723 ↗
• MalfunctionJun 29, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT 2 UNITS OF INTERMITTENT CATHETER HAD RAISED BUBBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12087285 ↗
• MalfunctionJun 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 3 UNITS OF INTERMITTENT CATHETERS WERE CONTAMINATED. IT WAS NOTED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12087251 ↗
• MalfunctionJun 29, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT 3 UNITS WITH SILICONE LEFTOVER EMBOSSED ON THE PROBE OF THE INTERMITTENT CATHETER. IT WAS STATED THAT THERE WAS NO IMPACT TO THE PATIENT AND THE PRODUCT WAS NOT AVAILABLE FOR SALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085876 ↗
• MalfunctionJan 6, 2021Inaccurate Flow Rate; Insufficient Device Problem Information; Inaccurate Flow Rate; Insufficient Device Problem Information

  IT WAS REPORTED THAT SOMETIMES THE PATIENT RECEIVED DEFECTIVE CATHETERS AND PATIENT TRIED TO USE ONE THIS WEEK THAT DID NOT HAD ANY SOLUTION IN THE BURST PACK. PER FOLLOW UP, THE CUSTOMER NOTED THAT SOMETIMES THERE IS NO DRAINAGE FROM THE CATHETERS AND THEY HAVE TO BE REPLACED.

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

  MAUDE report 11127839 ↗
• MalfunctionJan 6, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT THE SOMETIMES PATIENT RECEIVED DEFECTIVE CATHETERS AND PATIENT TRIED TO USE ONE THIS WEEK THAT DID NOT HAD ANY SOLUTION IN THE BURST PACK.

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

  MAUDE report 11127438 ↗
• MalfunctionDec 5, 2020Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THREE OF THE CATHETERS WERE NOT AS ¿SMOOTH¿ OR ¿COATED¿AND THEY WERE DIFFICULT TO INSERT, THE LUBRICANT WAS THICKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10954065 ↗
• MalfunctionDec 5, 2020Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THREE OF THE CATHETERS WERE NOT AS ¿SMOOTH¿ OR ¿COATED¿AND THEY WERE DIFFICULT TO INSERT. IT WAS ALSO STATED THAT THE LUBRICANT WAS THICKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10954006 ↗
• MalfunctionFeb 24, 2020Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT SAID IT WAS DIFFICULT TO OPEN THE BURST PACKETS. IN ADDITION, SHE STATED THAT THE CATHETERS WERE FLIMSY AND DIFFICULT FOR HER TO INSERT. IT WAS UNKNOWN IF THE PATIENT WAS ABLE TO VOID.

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

  MAUDE report 9745452 ↗
• MalfunctionNov 5, 2019Difficult to Insert; Product Quality Problem; Therapeutic or Diagnostic Output Failure; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS WERE NOT LUBRICATED ENOUGH. THE PATIENT WAS NOT ABLE TO FULLY INSERT THE CATHETER FOR USE.

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

  MAUDE report 9279823 ↗
• MalfunctionFeb 6, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER HAD A LACK OF LUBRICITY.

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

  MAUDE report 8311575 ↗
• InjuryDec 10, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PATIENT WAS SENT THE WRONG CATHETERS. THE PATIENT USED THE CATHETERS AND ALLEGEDLY DEVELOPED AN INFECTION. THE INFECTION WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8148624 ↗
• MalfunctionSep 19, 2018Short Fill

  IT WAS REPORTED THAT THE WATER PACKET INCLUDED WITH THE CATHETER DID NOT HAVE ENOUGH WATER.

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

  MAUDE report 7890183 ↗
• MalfunctionSep 19, 2018Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER WAS BENT AT THE END.

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

  MAUDE report 7888997 ↗
• MalfunctionAug 28, 2018Misassembled; Manufacturing, Packaging or Shipping Problem; Misassembled

  IT WAS REPORTED THAT THE CATHETER DID NOT HAVE DRAINAGE EYES.

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

  MAUDE report 7824881 ↗
• MalfunctionAug 14, 2018Product Quality Problem; Output Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY. IT WAS LATER REPORTED THAT THE PATIENT WAS UNABLE TO USE THE CATHETER DUE TO THE LACK OF LUBRICATION.

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

  MAUDE report 7783145 ↗
• MalfunctionAug 6, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER HAD A LACK OF LUBRICITY.

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

  MAUDE report 7751616 ↗
• MalfunctionJun 5, 2018Incorrect Measurement; No Flow; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE TAPERED AT THE ENDS AND RESULTED IN SLOWER DRAINAGE.

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

  MAUDE report 7569947 ↗
• MalfunctionJun 5, 2018Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE TWISTED, HOWEVER THE PATIENT WAS STILL ABLE TO USE THE CATHETERS.

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

  MAUDE report 7569263 ↗
• MalfunctionJun 5, 2018Bent; Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER TIPS WERE BENT, HOWEVER THE CATHETERS WERE STILL ABLE TO BE USED.

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

  MAUDE report 7569252 ↗