Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53618GRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741069796), received between May 24, 2017 and Jul 26, 2021 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH MAGIC 3 INTERMITTENT CATHETER THAT WERE NOT SELF-LUBRICATING. PER ADDITIONAL INFORMATION VIA PHONE ON 19JUL2021, PATIENT ADVISED THE CATHETER NOW CAUSED PATIENT BLEEDING ISSUES. THE PATIENT HAD NOW CONFIRMED A REORDER FOR PREFERRED PRODUCT AND ISSUE HAS BEEN RESOLVED. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 12224220 ↗
• MalfunctionApr 17, 2020Material Twisted/Bent; Packaging Problem

  IT WAS REPORTED THAT THE CATHETERS WERE BENT IN THE PACKAGING BEFORE USE.

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

  MAUDE report 9974923 ↗
• MalfunctionDec 18, 2019Misassembled; Misassembled; Component Missing; No Flow

  IT WAS REPORTED THAT ONE OF THE CATHETERS WAS MISSING THE EYELET, AND WAS UNABLE TO DRAIN. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9490047 ↗
• MalfunctionOct 7, 2019Fluid/Blood Leak; Short Fill; Short Fill

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH WATER IN THE BURST PACKET. THE COMPLAINANT NOTED THAT A LOT OF THE WATER WENT INSIDE THE CATHETERS AND NOT ON THE OUTSIDE.

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

  MAUDE report 9163690 ↗
• MalfunctionSep 16, 2019Burst Container or Vessel; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CONTENTS OF THE BURST PACKET SEEMED MORE GEL-LIKE THAN WATERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9071125 ↗
• InjuryAug 13, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE "HARD TO USE." THE PATIENT REPORTEDLY DEVELOPED A UTI AFTER USING THE CATHETERS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8887862 ↗
• InjuryJul 3, 2019Device Damaged Prior to Use; Difficult to Insert; Material Too Rigid or Stiff; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE MAGIC 3 HYDRO CATHETERS WERE STIFF AND SHARP RENDERING THEM HARD TO INSERT. THE PATIENT EXPERIENCED SELF-LIMITED BLEEDING. THE PATIENT WAS ABLE TO VOID WITH CATHETERS, HOWEVER, HE ALLEGEDLY CONTRACTED AN URINARY TRACT INFECTION FROM USE OF THE CATHETER. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem; Urinary Tract Infection

  MAUDE report 8757897 ↗
• MalfunctionMar 13, 2019Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE EYELETS WERE ROUGH DURING INSERTION OF THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8417664 ↗
• InjuryDec 26, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CATHETER CAUSED SOME IRRITATION INSIDE OF THE PATIENTS PENIS DURING AND AFTER INSERTION OF THE CATHETER. THE PATIENT WAS ABLE TO COMPLETELY INSERT AND VOID USING THE CATHETER. THE PATIENT WAS TREATED WITH A THREE DAY ANTIBIOTIC PRESCRIPTION FOR A URINARY TRACT INFECTION.

  Patient problems: Skin Irritation; Urinary Tract Infection

  MAUDE report 8196999 ↗
• MalfunctionMay 29, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE HYDROPHILIC COATING ON THE MAGIC 3 CATHETERS WERE UNEVEN. THE COATING ALLEGEDLY CLUMPS IN ONE SPOT, FELT SLIMY AND LACKED LUBRICITY IN OTHER AREAS. THE PATIENT ALLEGEDLY EXPERIENCED IRRITATION OF HIS URETHRA, PAIN, AND SELF-LIMITED BLEEDING. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Irritation; Pain

  MAUDE report 7550606 ↗
• MalfunctionMay 29, 2018Short Fill; Device Operates Differently Than Expected; Short Fill

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH STERILE WATER IN THE BURST PACKETS OF THE MAGIC 3 CATHETERS.

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

  MAUDE report 7548739 ↗
• MalfunctionMay 25, 2018Burst Container or Vessel; Short Fill; Short Fill

  IT WAS REPORTED THAT THE BURST PACKETS WERE SHORT FILLED, ALLEGEDLY MAKING THEM DIFFICULT TO INSERT.

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

  MAUDE report 7546463 ↗
• MalfunctionMay 24, 2018Burst Container or Vessel; Short Fill; Short Fill

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER BURST PACKETS WERE SHORT FILLED, THEREFORE THE PATIENT DID NOT USE THEM.

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

  MAUDE report 7542182 ↗
• MalfunctionSep 14, 2017Product Quality Problem

  IT WAS REPORTED THAT THE DEVICE LACKED LUBRICITY, BECAUSE THE WATER SACHET DID NOT HAVE THE PROPER AMOUNT OF LIQUID.

  Patient problems: No Information

  MAUDE report 6865213 ↗
• MalfunctionSep 14, 2017Difficult to Insert

  IT WAS REPORTED THAT THERE WAS A LACK OF LUBRICANT WITHIN THE POUCH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6864833 ↗
• MalfunctionSep 14, 2017Difficult to Insert; Component Missing

  IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO INSERT THE CATHETER, BUT WAS UNABLE TO DUE TO A LACK OF LUBRICITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6864653 ↗
• MalfunctionSep 6, 2017Material Integrity Problem

  IT WAS REPORTED THAT THE POUCH LACKED LUBRICANT.

  Patient problems: No Information

  MAUDE report 6845196 ↗
• MalfunctionSep 6, 2017Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER LACKS LUBRICITY AND BECOMES HARDER TO INSERT AS IT SLIDES IN.

  Patient problems: No Information

  MAUDE report 6845193 ↗
• InjuryAug 8, 2017Difficult to Insert

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY. THE COMPLAINANT ALLEGED THAT CATHETER WAS STILL INSERTED AND ALLOWED VOIDING. IT WAS NOTED THAT USER EXPERIENCED A RIPPED URETHRA, SELF-LIMITED BLEEDING AND DISCOMFORT. THE COMPLAINANT ALSO NOTED THAT MEDICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Tissue Damage

  MAUDE report 6775563 ↗
• MalfunctionMay 24, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE WATER PACKET DID NOT LUBRICATE THE CATHETER ENOUGH.

  Patient problems: No Information

  MAUDE report 6589191 ↗