Magic3™ Hydrophilic Intermittent Catheter, Male 53614GSRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741072659), received between Aug 9, 2017 and Jun 24, 2022 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Kinked” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE COLLECTION BAG WAS MISSING FROM INTERMITTENT CATHETER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800531 ↗
• MalfunctionOct 10, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE BENT AND TWISTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174955 ↗
• MalfunctionOct 8, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE BENT AND TWISTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9168350 ↗
• MalfunctionOct 7, 2019Material Twisted/Bent; Packaging Problem

  IT WAS REPORTED THAT THE FIRST INCH OF THE CATHETERS WERE BENT DUE TO BAD PACKAGING. THIS RESULTED IN THE PATIENT EXPERIENCING SELF LIMITED BLEED DURING INSERTION OF THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9161888 ↗
• MalfunctionJul 10, 2019Material Twisted/Bent

  IT WAS REPORTED THAT SOME OF THE CATHETERS WERE BENT. IT WAS LATER REPORTED PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON 02JUL2019, THE CATHETERS WERE FOLDED IN HALF INSIDE THE PACKAGING AND WERE STILL BENT WHEN THEY WERE REMOVED. THE PATIENT REPORTEDLY EXPERIENCED PAIN ONCE THE CATHETER WAS INSERTED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8776179 ↗
• MalfunctionJun 21, 2019Short Fill; Burst Container or Vessel; Short Fill; Component Missing

  IT WAS REPORTED THAT 10 OF THE CATHETERS HAD BURST PACKETS THAT HAD NO SOLUTION AND THE PATIENT DID NOT USE THEM. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8722711 ↗
• MalfunctionMay 15, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH LUBRICATION ON SOME OF THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8612460 ↗
• MalfunctionJul 9, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH LUBRICANT ON THE MAGIC 3 CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7670599 ↗
• MalfunctionApr 23, 2018Product Quality Problem; Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO FULLY INSERT THE CATHETER AFTER LETTING THE CATHETER SIT FOR 30 SECONDS IN THE LUBRICATION. THE PATIENT REPORTEDLY ADDED LUBRICATION THAT HE PURCHASED AND WAS ABLE TO INSERT THE CATHETER.

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

  MAUDE report 7452578 ↗
• MalfunctionApr 23, 2018Product Quality Problem; Product Quality Problem; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO FULLY INSERT THE CATHETER AFTER LETTING THE CATHETER SIT FOR 30 SECONDS IN THE LUBRICATION. THE PATIENT REPORTEDLY ADDED LUBRICATION THAT HE PURCHASED AND WAS THEN ABLE TO INSERT THE CATHETER.

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

  MAUDE report 7452500 ↗
• MalfunctionDec 6, 2017Bent

  IT WAS REPORTED THAT THE CATHETER WAS BENT, WHICH PUT PRESSURE ON THE URETHRA AFTER INSERTION.

  Patient problems: Discomfort

  MAUDE report 7087017 ↗
• MalfunctionOct 24, 2017Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY. THE PATIENT REPORTEDLY EXPERIENCED SELF LIMITED BLEEDING AFTER USE.

  Patient problems: Blood Loss

  MAUDE report 6973137 ↗
• MalfunctionAug 22, 2017Kinked; Folded

  IT WAS REPORTED THAT THE CATHETER WAS FOLDED IN HALF INSIDE THE PACKAGING, WHICH CAUSED A KINK AND MADE THE PRODUCT UNUSABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6810976 ↗
• MalfunctionAug 22, 2017Kinked; Folded

  IT WAS REPORTED THAT THE CATHETER WAS FOLDED IN HALF INSIDE THE PACKAGING, WHICH CAUSED A KINK AND MADE THE PRODUCT UNUSABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6810842 ↗
• MalfunctionAug 14, 2017Kinked; Device Inoperable

  IT WAS REPORTED THAT THE CATHETER WAS FOLDED IN HALF INSIDE THE PACKAGING CAUSING A KINK, AND MAKING THE PRODUCT UNUSABLE.

  Patient problems: No Patient Involvement

  MAUDE report 6793394 ↗
• InjuryAug 11, 2017Kinked; Folded; Packaging Problem

  IT WAS REPORTED THAT THE CATHETER WAS FOLDED IN HALF INSIDE THE PACKAGING CAUSING A KINK. WHEN THE PATIENT INSERTED THE CATHETER, THE CATHETER ALLEGEDLY CUT THE PATIENT'S PENIS AND CAUSED HIM EXCRUCIATING PAIN. THE PATIENT REPORTEDLY REMOVED THE CATHETER WITHOUT DRAINING THE URINE AND USED ANOTHER CATHETER SUCCESSFULLY. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Pain

  MAUDE report 6789881 ↗
• MalfunctionAug 9, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  IT WAS REPORTED THAT THE CATHETER WAS FOLDED IN HALF INSIDE THE PACKAGING CREATING A KINK. THE USER WAS UNABLE TO USE THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6780468 ↗
• MalfunctionAug 9, 2017Product Quality Problem

  IT WAS REPORTED THAT THE WATER SACHET DID NOT HAVE ENOUGH WATER IN IT TO LUBRICATE THE CATHETER COMPLETELY. THE PATIENT STATED THAT IT FELT LIKE WHAT HE WOULD IMAGINE INSERTING A "NAIL FILE" WOULD FEEL LIKE AND CAUSED DISCOMFORT UPON INSERTION. THE PATIENT WAS ALLEGEDLY UNABLE TO DRAIN URINE WITH THE CATHETER, BUT OBTAINED ANOTHER CATHETER AND DRAINED URINE SUCCESSFULLY.

  Patient problems: Discomfort; Urinary Retention

  MAUDE report 6780450 ↗
• MalfunctionAug 9, 2017Kinked

  IT WAS REPORTED THAT THE CATHETER WAS FOLDED IN HALF INSIDE THE PACKAGING CREATING A KINK AND MAKING THE PRODUCT UNUSABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6780338 ↗
• MalfunctionAug 9, 2017Kinked; Folded; Packaging Problem

  IT WAS REPORTED THAT THE CATHETER WAS FOLDED IN HALF INSIDE THE PACKAGING AND CREATED A KINK. THE USER WAS UNABLE TO USE THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6780015 ↗
• MalfunctionAug 9, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THERE WERE MULTIPLE DIFFERENT LOT NUMBERS IN A SEALED BARD CASE THAT THE PATIENT RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6776590 ↗