Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53516GRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741069727), received between Jun 20, 2017 and Jan 31, 2022 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT WAS REUSING THE MAGIC 3 GO HYDROPHILIC MALE INTERMITTENT CATHETER AND RUNNING UNDER WATER TO RE LUBRICATE THE CATHETER. IT WAS ALSO STATED THAT THE PATIENT EXPERIENCED BLEEDING WHILE USING THE CATHETER. THE REPRESENTATIVE ADVISED THAT THE RUNNING UNDER WATER WOULD NOT RE LUBRICATE THE CATHETERS, AND THEY ONLY MEANT TO BE ONE TIME USE. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 13392937 ↗
• MalfunctionSep 23, 2019Burst Container or Vessel; Short Fill

  IT WAS REPORTED THAT THE PATIENT STATED THAT THERE WAS NOT ENOUGH WATER IN THE BURST PACKET.

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

  MAUDE report 9107211 ↗
• InjuryJul 2, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD 3 INFECTIONS WHILE USING THE MAGIC 3 CATHETER. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON 21JUN2019, THE CATHETER WAS IN USE FOR A COUPLE DAYS WHEN THE ISSUE WAS NOTICED AND THE INFECTION WAS TREATED WITH PRESCRIBED CIPROFLOXACIN ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8755192 ↗
• MalfunctionJul 2, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 GO CATHETERS LACKED LUBRICITY. THE PATIENT ALLEGED THAT IT DIDN'T FEEL LIKE THE HYDROPHILLLIC COATING WAS WORKING ON SOME OF THE CATHETERS. THE PATIENT WAS ABLE TO VOID WITH CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8754963 ↗
• MalfunctionApr 17, 2019Device Damaged Prior to Use; Appropriate Device Problem Term/Code Not Available; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE PATIENT NOTICED A SMALL HARD BUMP NEAR ONE EYELET WHICH CAUSED DISCOMFORT DURING REMOVAL OF THE CATHETER. THE PATIENT WAS ABLE TO VOID. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 8524867 ↗
• MalfunctionFeb 19, 2019Difficult to Insert; Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETERS WERE TOO WIDE, CAUSING THEM TO BE DIFFICULT TO INSERT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8350434 ↗
• MalfunctionFeb 13, 2019Component Missing

  IT WAS REPORTED THAT THE WATER SACHET WAS MISSING FROM THE PACKAGING OF THE MAGIC 3 CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8334545 ↗
• MalfunctionJan 30, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC3 CATHETER WAS NOT LUBRICATED ALL THE WAY AND MADE IT DIFFICULT TO INSERT.

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

  MAUDE report 8290412 ↗
• MalfunctionDec 3, 2018Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SELF LIMITED BLEEDING AFTER THE USE OF THE MAGIC 3 CATHETER AND WAS NOT ABLE TO FULLY INSERT THE CATHETER FOR USE. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND WAS TOLD THAT THE ISSUE WAS "FALSE PASSAGES". THE PATIENT WAS GIVEN WHAT WAS BELIEVED TO BE A 14 FR (SPEEDI) CATHETER TO TRY AND WAS ABLE TO INSERT IT WITHOUT AN ISSUE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8125580 ↗
• MalfunctionNov 13, 2018Product Quality Problem; Product Quality Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE NOT LUBRICATED ENOUGH. THE PATIENT WAS ABLE TO USE SOME OF THE CATHETERS AFTER REPEATED INSERTION ATTEMPTS WITH SOME DIFFICULTY AND DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; No Consequences Or Impact To Patient

  MAUDE report 8066756 ↗
• MalfunctionOct 31, 2018Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024360 ↗
• MalfunctionOct 31, 2018Incorrect Measurement; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CATHETER DIAMETER SEEMED WIDER THAN USUAL. THE PATIENT ALLEGEDLY EXPERIENCED SELF-LIMITED BLEEDING. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 8024351 ↗
• MalfunctionSep 27, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER HAD A LACK OF LUBRICITY UPON INSERTION. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7914939 ↗
• MalfunctionSep 10, 2018Product Quality Problem; Appropriate Device Problem Term/Code Not Available; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY.

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

  MAUDE report 7861907 ↗
• MalfunctionJul 18, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE WATER IN THE SACHET FOR THE MAGIC 3 CATHETER WAS "CLUMPY". NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7698147 ↗
• MalfunctionMay 2, 2018Short Fill; Short Fill; Component Missing

  IT WAS REPORTED THAT THE WATER SACHET DID NOT HAVE THE PROPER AMOUNT OF WATER.

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

  MAUDE report 7479740 ↗
• MalfunctionApr 27, 2018Product Quality Problem; Product Quality Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS LACKED LUBRICATION AND CAUSED DAMAGE TO THE PATIENT'S URETHRA. IT WAS ALSO NOTED THAT THIS RESULTED IN THE PATIENT HAVING TO USE A FOLEY CATHETER FOR APPROXIMATELY A WEEK AND A HALF. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Injury; Tissue Damage

  MAUDE report 7468667 ↗
• MalfunctionJun 20, 2017Product Quality Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER DID NOT LUBRICATE, SUBSEQUENTLY BEING UNABLE TO BE INSERTED INTO THE PATIENT'S BLADDER. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND SELF-LIMITED BLEEDING. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Blood Loss; Pain

  MAUDE report 6654641 ↗